## Protocol Section
### Identification Module
**NCT ID:** NCT01420679

**Brief Title:** Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients

**Official Title:** A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy

#### Organization Study ID Info
**ID:** PDX-017
#### Organization
**Class:** INDUSTRY
**Full Name:** Spectrum Pharmaceuticals, Inc
#### Secondary ID Infos
**ID:** 2010-022230-81
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2017-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-11-19

**Type:** ACTUAL

**Last Update Submit Date:** 2021-11-18

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2017-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-11-19

**Type:** ACTUAL

**Results First Submit Date:** 2021-10-01

**Results First Submit QC Date:** 2021-11-18

#### Start Date
**Date:** 2011-08

**Type:** ACTUAL

**Status Verified Date:** 2021-11

#### Study First Post Date
**Date:** 2011-08-22
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-18
**Study First Submit QC Date:** 2011-08-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Spectrum Pharmaceuticals, Inc

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.

**Detailed Description:** This was an international, multi-center, randomized, Phase 3, open-label study of sequential pralatrexate versus observation in patients with previously undiagnosed PTCL who have achieved an objective response following initial treatment with CHOP-based chemotherapy.

Upon documentation of completion of an objective response following at least 6 cycles of a designated CHOP-based chemotherapy confirmation of histopathology by independent review, and confirmation that all eligibility criteria were met, patients were randomized in a 2:1 ratio to either pralatrexate or observation, according to a permuted block design with stratification factor of Tumor Response per Investigator at completion of CHOP-based therapy (Complete Response \[CR\] vs Partial Response \[PR\]).

All patients who receive at least 1 dose of pralatrexate were followed for safety through 35 (± 5) days after their last dose of pralatrexate or until all treatment-related AEs have resolved or returned to baseline/Grade 1, whichever is longer, or until it was determined that the outcome does not change with further follow-up.

### Conditions Module

**Conditions:**

- Peripheral T-cell Lymphoma

**Keywords:**

- Lymphoproliferative Disorders

- Lymphoma

- Non-Hodgkin's Lymphoma

- T-cell Lymphoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 21

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients randomized to the Pralatrexate Arm will receive pralatrexate injection and Vitamins B12 and Folic Acid until a criterion for pralatrexate injection treatment discontinuation is met.

**Intervention Names:**

- Drug: Pralatrexate Injection

**Label:** Pralatrexate

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients randomized to the Observation Arm will receive Vitamins B12 and Folic Acid and remain under observation until a criterion for observation discontinuation is met.

**Label:** Observation

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pralatrexate

**Description:** Intravenous (IV) push administration over 30 seconds to 5 minutes via a patent IV line containing normal saline (0.9% sodium chloride).

Initial dose: 30 mg/m2

Administered weekly for 3 weeks of a 4-week cycle until criteria for discontinuation per the protocol are met.

**Name:** Pralatrexate Injection

**Other Names:**

- FOLOTYN

- PDX

- Pralatrexate

- (RS)-10-propargyl-10-deazaaminopterin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** PFS was defined as the time in days from randomization to the date of objective documentation of progressive disease (PD) or death, regardless of cause (date of PD or death - date of randomization + 1). PFS was to be assessed according to the International Workshop Criteria (IWC) without including positron emission tomography (PET). PD was defined as any new lesion or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir. Participants who were alive without a disease response assessment of PD was to be censored at their last disease assessment date or the date of randomization, whichever was later. Date of progression was not to be imputed for participants with missing tumor assessments before an assessment of PD. Participants who withdraw from treatment prior to PD were to be followed for disease status whenever possible. Participants who have no response assessments after baseline were to be censored at randomization.

**Measure:** Progression-Free Survival (PFS)

**Time Frame:** From randomization to the date of progression of disease or death due to any cause (up to 76 months)

**Description:** Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1).

**Measure:** Overall Survival (OS)

**Time Frame:** From randomization until death (up to 76 months)

#### Secondary Outcomes

**Description:** Objective response rate was defined as percentage of participants with an objective response of complete response (CR) or partial response (PR), relative to disease status at the time of study entry. The percentage was to be calculated by dividing number of participants within each category of response by the number of participants with measurable disease at baseline. Objective response was assessed according to the IWC without including PET. CR was defined as complete disappearance all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR was defined as regression of measurable disease and no new sites.

**Measure:** Objective Response Rate

**Time Frame:** Up to 2 years

**Description:** An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of "Hematology and Chemistry" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences.

**Measure:** Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities

**Time Frame:** From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification:

  * T/natural killer (NK)-cell leukemia/lymphoma
  * Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+)
  * Angioimmunoblastic TCL
  * Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy
  * PTCL-unspecified
  * Enteropathy-type intestinal lymphoma
  * Hepatosplenic TCL
  * Subcutaneous panniculitis TCL
  * Transformed mycosis fungoides (tMF)
  * Extranodal T/NK-cell lymphoma nasal or nasal type
  * Primary cutaneous gamma-delta TCL
  * Primary cutaneous CD8+ aggressive epidermic cytotoxic TCL
* Documented completion of at least 6 cycles of CHOP-based therapy:

  * CHOP 21
  * CHOP 14
  * CHOP + etoposide
  * Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization.
* Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization.
* Eastern Cooperative Oncology Group performance status less than or equal to 2.
* Adequate blood, liver, and kidney function as defined by laboratory tests.
* Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate.
* Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate.
* Has given written informed consent.

Exclusion Criteria:

* Patient has:

  * Precursor T/NK neoplasms
  * ALCL (ALK+) with IPI score less than 2 at initial diagnosis and CR after CHOP-based therapy
  * T cell prolymphocytic leukemia
  * T cell large granular lymphocytic leukemia
  * Mycosis fungoides, except tMF
  * Sézary syndrome
  * Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis
* If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease.

  * non-melanoma skin cancer
  * carcinoma in situ of the cervix
  * localized prostate cancer
  * localized thyroid cancer
* Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except:

  * Patients with nasal NK lymphoma who received local RT less than 4 weeks prior to randomization.
  * Patients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation.
* Prior exposure to pralatrexate.
* Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of 10 mg/day or less of oral prednisone or equivalent for at least 4 weeks or as part of a CHOP prednisone taper.
* Planned use of any treatment for PTCL during the course of the study.
* Patient has:

  * Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and receiving anti-retroviral therapy.
  * Hepatitis B (HBV)-positive serology and is receiving interferon therapy or has liver function test results outside the parameters of study inclusion criteria. Other antiviral therapies are permitted if at a stable dose for at least 4 weeks.
  * Hepatitis C (HCV) virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
  * Symptomatic central nervous system metastases or lesions requiring treatment.
  * Uncontrolled hypertension or congestive heart failure Class III/IV per the New York Heart Association's Heart Failure Guidelines
  * Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability of the patient to receive protocol treatment.
* Major surgery within 2 weeks prior to study entry, except for line placement or biopsy procedure.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Novi

**Country:** United States

**Facility:** Detroit Clinical Research Center, PC

**State:** Michigan

**Zip:** 48377

**Location 2:**

**City:** New York

**Country:** United States

**Facility:** New York Presbyterian Hospital

**State:** New York

**Zip:** 10021

**Location 3:**

**City:** New York

**Country:** United States

**Facility:** Memorial Sloan-Kettering Cancer Center

**State:** New York

**Zip:** 10065

**Location 4:**

**City:** Adelaide

**Country:** Australia

**Facility:** Royal Adelaide Hospital

**State:** South Australia

**Zip:** 5000

**Location 5:**

**City:** Bedford Park

**Country:** Australia

**Facility:** Flinders Medical Center

**State:** South Australia

**Zip:** 5042

**Location 6:**

**City:** Hobart

**Country:** Australia

**Facility:** Royal Hobart Hospital

**State:** Tasmania

**Zip:** 7001

**Location 7:**

**City:** Clayton

**Country:** Australia

**Facility:** Monash Medical Centre

**State:** Victoria

**Zip:** 3168

**Location 8:**

**City:** Fitzroy

**Country:** Australia

**Facility:** Saint Vincent's Hospital Melbourne

**State:** Victoria

**Zip:** 3109

**Location 9:**

**City:** Frankston

**Country:** Australia

**Facility:** Frankston Hospital

**State:** Victoria

**Zip:** 3199

**Location 10:**

**City:** Malvern

**Country:** Australia

**Facility:** Cabrini Health

**State:** Victoria

**Zip:** 3144

**Location 11:**

**City:** Perth

**Country:** Australia

**Facility:** Royal Perth Hospital

**State:** Western Australia

**Zip:** 6000

**Location 12:**

**City:** Brugge

**Country:** Belgium

**Facility:** AZ Sint-Jan

**Zip:** 8000

**Location 13:**

**City:** Gent

**Country:** Belgium

**Facility:** Universitair Ziekenhuis Gent

**Zip:** 9000

**Location 14:**

**City:** Toronto

**Country:** Canada

**Facility:** Sunnybrook Health Science Centre

**State:** Ontario

**Zip:** M4N 3M5

**Location 15:**

**City:** Montreal

**Country:** Canada

**Facility:** Hôpital du Sacré-Coeur de Montréal

**State:** Quebec

**Zip:** H4J 1C5

**Location 16:**

**City:** Brest

**Country:** France

**Facility:** Hôpital Morvan

**Zip:** 29609

**Location 17:**

**City:** Pessac

**Country:** France

**Facility:** CHU Haut-Leveque

**Zip:** 33604

**Location 18:**

**City:** Dublin 8

**Country:** Ireland

**Facility:** St James Hospital

**Location 19:**

**City:** Jerusalem

**Country:** Israel

**Facility:** Shaare Zedek Medical Center

**Zip:** 91031

**Location 20:**

**City:** Jerusalem

**Country:** Israel

**Facility:** Hadassah Ein-Kerem Medical Centre

**Zip:** 91120

**Location 21:**

**City:** Petach Tikva

**Country:** Israel

**Facility:** Rabin Medical Center

**Zip:** 49100

**Location 22:**

**City:** Tel Hashomer

**Country:** Israel

**Facility:** Chaim Sheba Medical Center

**Zip:** 52621

**Location 23:**

**City:** Meldola

**Country:** Italy

**Facility:** Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

**State:** Forli

**Zip:** 47014

**Location 24:**

**City:** Bologna

**Country:** Italy

**Facility:** Az. Ospedaliera Universitaria S. Orsola Malpighi

**Zip:** 40138

**Location 25:**

**City:** Brescia

**Country:** Italy

**Facility:** Spedali Civili di Brescia

**Zip:** 25123

**Location 26:**

**City:** Ravenna

**Country:** Italy

**Facility:** Ospedale S. Maria delle Croci

**Zip:** 48121

**Location 27:**

**City:** Roma

**Country:** Italy

**Facility:** Università Cattolica del Sacro Cuore

**Zip:** 00168

**Location 28:**

**City:** Siena

**Country:** Italy

**Facility:** Az. Ospedaliera Università Senese

**Zip:** 53100

**Location 29:**

**City:** Otahuhu

**Country:** New Zealand

**Facility:** Middlemore Hospital

**State:** Auckland

**Zip:** 1640

**Location 30:**

**City:** Auckland

**Country:** New Zealand

**Facility:** Auckland City Hospital / Auckland University

**Zip:** 1010

**Location 31:**

**City:** Christchurch

**Country:** New Zealand

**Facility:** Christchurch Hospital

**Zip:** 8011

**Location 32:**

**City:** Milford

**Country:** New Zealand

**Facility:** North Shore Hospital

**Location 33:**

**City:** Warszawa

**Country:** Poland

**Facility:** Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie

**State:** Mazowieckie

**Zip:** 02-781

**Location 34:**

**City:** Gdansk

**Country:** Poland

**Facility:** Dept of Hematology and Transplantology

**Zip:** 80-952

**Location 35:**

**City:** Kraków

**Country:** Poland

**Facility:** Małopolskie Centrum Medyczne

**Zip:** 30-510

**Location 36:**

**City:** San Juan

**Country:** Puerto Rico

**Facility:** Auxilio Mutuo Cancer Center

**Zip:** 00918

**Location 37:**

**City:** Pamplona

**Country:** Spain

**Facility:** Clinica Universidad de Navarra

**State:** Navarra

**Zip:** 31008

**Location 38:**

**City:** Pamplona

**Country:** Spain

**Facility:** Complejo Hospitalario de Navarra, Servicio de Hematologia

**State:** Navarra

**Zip:** 31008

**Location 39:**

**City:** A Coruña

**Country:** Spain

**Facility:** Complejo Hospitalario Universitario A Coruña- Hospital A Coruña

**Zip:** 15006

**Location 40:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital General Vall d'Hebron

**Zip:** 08035

**Location 41:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Clínic i Provincial de Barcelona

**Zip:** 08036

**Location 42:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario Ramón y Cajal

**Zip:** 28034

**Location 43:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital de Madrid Norte-Sanchinarro

**Zip:** 28050

**Location 44:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario Puerta de Hierro Majadahonda

**Zip:** 28222

**Location 45:**

**City:** Truro

**Country:** United Kingdom

**Facility:** Royal Cornwall Hospital

**State:** Cornwall

**Zip:** TR1 3LJ

**Location 46:**

**City:** Poole

**Country:** United Kingdom

**Facility:** Poole Hospital NHS Foundation Trust, Poole General Hospital

**State:** Dorset

**Zip:** BH15 2JB

**Location 47:**

**City:** Plymouth

**Country:** United Kingdom

**Facility:** Derriford Hospital

**State:** England

**Zip:** PL68DH

**Location 48:**

**City:** West Bromwich

**Country:** United Kingdom

**Facility:** Sandwell & West Birmingham Hospitals NHS Trust

**State:** England

**Zip:** B71 4HJ

**Location 49:**

**City:** Antrim

**Country:** United Kingdom

**Facility:** Antrim Area Hospital

**State:** Northern Ireland

**Zip:** BT41 2RL

**Location 50:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** NHS Greater Glasgow and Clyde Western Infirmary

**State:** Scotland

**Zip:** G11 6NT

**Location 51:**

**City:** Belfast

**Country:** United Kingdom

**Facility:** Belfast City Hospital

**Zip:** BT9 7AB

**Location 52:**

**City:** Cardiff

**Country:** United Kingdom

**Facility:** Velindre Hospital

**Zip:** CF14 2TL

**Location 53:**

**City:** Liverpool

**Country:** United Kingdom

**Facility:** Royal Liverpool University Hospital

**Zip:** L7 8XP

**Location 54:**

**City:** Middlesex

**Country:** United Kingdom

**Facility:** Mount Vernon Cancer Centre

**Zip:** HA6 2RN

**Location 55:**

**City:** Warwick

**Country:** United Kingdom

**Facility:** UHCW (University Hospital Coventry and Warwickshire)

**Zip:** CA34 5BW

## Document Section

### Large Document Module

#### Large Docs

- Date: 2011-10-31

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 14850796

- Type Abbrev: Prot

- Upload Date: 2021-10-01T10:27

- Date: 2012-04-18

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 297079

- Type Abbrev: SAP

- Upload Date: 2021-10-01T10:28

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M18829

- Name: Lymphoma, T-Cell

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M18833

- Name: Lymphoma, T-Cell, Peripheral

- Relevance: HIGH

- As Found: Peripheral T-cell Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T4496

- Name: Peripheral T-cell Lymphoma

- Relevance: HIGH

- As Found: Peripheral T-cell Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000016399

- Term: Lymphoma, T-Cell

- ID: D000016411

- Term: Lymphoma, T-Cell, Peripheral

### Intervention Browse Module - Ancestors

- ID: D000005493

- Term: Folic Acid Antagonists

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M17548

- Name: Vitamin B 12

- Relevance: LOW

- As Found: Unknown

- ID: M9934

- Name: Hydroxocobalamin

- Relevance: LOW

- As Found: Unknown

- ID: M237319

- Name: 10-deazaaminopterin

- Relevance: HIGH

- As Found: Repairing

- ID: M3968

- Name: Aminopterin

- Relevance: HIGH

- As Found: Patient navigator

- ID: M8619

- Name: Folic Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T451

- Name: Methylcobalamin

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

- ID: T476

- Name: Vitamin B12

- Relevance: LOW

- As Found: Unknown

- ID: T441

- Name: Cobalamin

- Relevance: LOW

- As Found: Unknown

- ID: T444

- Name: Cyanocobalamin

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000017178

- Term: 10-deazaaminopterin

- ID: D000000630

- Term: Aminopterin

### Misc Info Module

#### Removed Countries

- Country: Austria

- Country: Brazil

- Country: Bulgaria

- Country: Chile

- Country: Colombia

- Country: Czech Republic

- Country: Germany

- Country: Hong Kong

- Country: Hungary

- Country: Korea, Republic of

- Country: Mexico

- Country: Peru

- Country: Romania

- Country: Russian Federation

- Country: Singapore

- Country: Taiwan

- Country: Ukraine

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.

#### Event Groups

**Group ID:** EG000

**Title:** Pralatrexate Arm

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 14

**Description:** Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.

**ID:** EG000

**Other Num Affected:** 14

**Other Num at Risk:** 14

**Serious Number Affected:** 4

**Serious Number At Risk:** 14

**Title:** Pralatrexate Arm

**Group ID:** EG001

**Title:** Observation Arm

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 7

**Description:** Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.

**ID:** EG001

**Other Num Affected:** 6

**Other Num at Risk:** 7

**Serious Number At Risk:** 7

**Title:** Observation Arm

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Abdominal Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Aphthous stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dry mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Haematochezia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Haemorrhoids

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Impaired gastric emptying

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Lip ulceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Oral dysaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Face oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Local swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Mucosal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Bronchitis Viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Clostridium difficile colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Conjunctivitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Cystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Diverticulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Fungal infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Rhinitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Viral infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

**Term:** Foot fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

**Term:** Skull fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

**Term:** Subdural haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

**Term:** Wound

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

**Term:** Body temperature increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

**Term:** Gammaglutamyltransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

**Term:** Weight increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 17.0

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Flank pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Musculoskeletal chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Musculoskeletal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Carotid artery occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Convulsion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dysaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Haemorrhage intracranial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Hypokinesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Lethargy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Neuropathy peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Sciatica

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** VIIth nerve paralysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Hallucination

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Mental status changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dysuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Nocturia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Urinary incontinence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Urinary tract pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dysphonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Hiccups

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Nasal congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Pleuritic pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Productive cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Rhinorrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Sneezing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Blister

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Eczema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Macule

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Melanosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Nail disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Night sweats

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Onychoclasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Penile ulceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Pigmentation disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Pruritus generalised

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Rash maculo-papular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Rash pruritic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Skin hyperpigmentation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Skin ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Varicose vein

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Cataract

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Ocular hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Visual acuity reduced

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Endodontic procedure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 17.0

**Term:** Stent removal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 17.0

**Term:** Erectile dysfunction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Sinus bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Ichthyosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Skin infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 17.0

**Term:** Decreased appetite/Anorexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Mucosal inflammation/Intermittant Mucositis of Mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

**Term:** Disturbance in attention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

#### Serious Events

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** Subdural hematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** Haemorrhage intracranial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** Carotid artery occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** VIIth nerve paralysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 17.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Group ID:** EG001

**Num At Risk:** 7

**Time Frame:** From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 14

**Group ID:** BG001

**Value:** 7

**Group ID:** BG002

**Value:** 21

**Units:** Participants

### Group

**ID:** BG000

**Title:** Pralatrexate Arm

**Description:** Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.

### Group

**ID:** BG001

**Title:** Observation Arm

**Description:** Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 51

**Upper Limit:** 83

**Value:** 72.0

#### Measurement

**Group ID:** BG001

**Lower Limit:** 44

**Upper Limit:** 83

**Value:** 61.0

#### Measurement

**Group ID:** BG002

**Lower Limit:** 44

**Upper Limit:** 83

**Value:** 68.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 13

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Black

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Arabic

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 15

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Missing

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** The study was prematurely terminated due to business reasons. There were no safety concerns that led to study closure. No efficacy assessments and analysis was conducted. A full statistical analysis and report were not completed.
### Point of Contact
**Email:** gajanan.Bhat@sppirx.com
**Organization:** Spectrum Pharmaceuticals, Inc
**Phone:** 949-743-9219
**Title:** Gajanan Bhat
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** Median and 95% CI were not estimable due to low number of participants with events.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Median and 95% CI were not estimable due to low number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 3
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** PFS was defined as the time in days from randomization to the date of objective documentation of progressive disease (PD) or death, regardless of cause (date of PD or death - date of randomization + 1). PFS was to be assessed according to the International Workshop Criteria (IWC) without including positron emission tomography (PET). PD was defined as any new lesion or increase by greater than or equal to (\>=) 50 percent (%) of previously involved sites from nadir. Participants who were alive without a disease response assessment of PD was to be censored at their last disease assessment date or the date of randomization, whichever was later. Date of progression was not to be imputed for participants with missing tumor assessments before an assessment of PD. Participants who withdraw from treatment prior to PD were to be followed for disease status whenever possible. Participants who have no response assessments after baseline were to be censored at randomization.
**Population Description:** Data for this outcome measure was not collected and analyzed due to the early termination of the study.
**Reporting Status:** POSTED
**Time Frame:** From randomization to the date of progression of disease or death due to any cause (up to 76 months)
**Title:** Progression-Free Survival (PFS)
**Type:** PRIMARY
##### Group
**Description:** Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
**ID:** OG000
**Title:** Pralatrexate Arm
##### Group
**Description:** Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
**ID:** OG001
**Title:** Observation Arm
#### Outcome Measure 2
**Description:** Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population included all randomized participants classified according to the treatment arms into which they were randomized, regardless of the actual study treatment received (or not received).
**Reporting Status:** POSTED
**Time Frame:** From randomization until death (up to 76 months)
**Title:** Overall Survival (OS)
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
**ID:** OG000
**Title:** Pralatrexate Arm
##### Group
**Description:** Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
**ID:** OG001
**Title:** Observation Arm
#### Outcome Measure 3
**Description:** Objective response rate was defined as percentage of participants with an objective response of complete response (CR) or partial response (PR), relative to disease status at the time of study entry. The percentage was to be calculated by dividing number of participants within each category of response by the number of participants with measurable disease at baseline. Objective response was assessed according to the IWC without including PET. CR was defined as complete disappearance all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR was defined as regression of measurable disease and no new sites.
**Population Description:** Data for this outcome measure was not collected and analyzed due to early termination of the study.
**Reporting Status:** POSTED
**Time Frame:** Up to 2 years
**Title:** Objective Response Rate
**Type:** SECONDARY
##### Group
**Description:** Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
**ID:** OG000
**Title:** Pralatrexate Arm
##### Group
**Description:** Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
**ID:** OG001
**Title:** Observation Arm
#### Outcome Measure 4
**Description:** An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of "Hematology and Chemistry" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.
**Reporting Status:** POSTED
**Time Frame:** From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)
**Title:** Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
**ID:** OG000
**Title:** Pralatrexate Arm
##### Group
**Description:** Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
**ID:** OG001
**Title:** Observation Arm
### Participant Flow Module
#### Group
**Description:** Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
**ID:** FG000
**Title:** Pralatrexate Arm
#### Group
**Description:** Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
**ID:** FG001
**Title:** Observation Arm
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Disease Progression
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** More Than 28 Days Between Doses of Drug
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Patient Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Investigator Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Sponsor Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
**Pre-Assignment Details:** A total of 21 participants with peripheral T-cell lymphoma (PTCL) were randomized in 2:1 ratio to Pralatrexate arm or Observation arm.
**Has Results:** True