Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer P... | NCT00063570

ID	Type	Description	Link
H3E-US-JMEO

Label	Type	Description	Intervention Names
A	Experimental		Drug: Pemetrexed Drug: Gemcitabine
B	Experimental		Drug: Gemcitabine Drug: Pemetrexed

Name	Type	Description	Arm Group Labels	Other Names
Pemetrexed	Drug	500 mg/m2, intravenous (IV), every 14 days, until disease progression	A

Measure	Description	Time Frame
Overall Tumor Response	Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.	Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

Measure	Description	Time Frame
Duration of (Confirmed) Complete Response or Partial Response	Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12).	Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.		Aurora	Colorado

ID	Title	Description
FG000	Bi-Weekly Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
FG001	21-Day Schedule

ID	Title	Description
BG000	Bi-Weekly Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
BG001	21-Day Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00052 BG00121 BG00273

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Tumor Response

Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.

Patients who received at least one dose of study drug (pemetrexed or gemcitabine) were included in the analyses.

Posted

Number

participants

Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated

ID	Title	Description
OG000	Bi-Weekly Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
OG001	21-Day Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.

Units	Counts
Participants	OG00052 OG00121

Title

Denominators

Categories

Complete Response

Title	Measurements
	OG0002 OG0010

Partial Response

Title	Measurements
	OG000

Secondary

Duration of (Confirmed) Complete Response or Partial Response

Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12).

Number of patients with a confirmed complete or partial response.

Posted

Median

Full Range

months

ID	Title	Description
OG000	Bi-Weekly Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
OG001	21-Day Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.

Units	Counts
Participants

Secondary

Time to Progressive Disease

Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12).

Intention to Treat analysis

Posted

Median

Full Range

months

ID	Title	Description
OG000	Bi-Weekly Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
OG001	21-Day Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.

Units	Counts
Participants

Secondary

Time to Treatment Failure

Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12)

Intention to Treat analysis

Posted

Median

Full Range

months

ID	Title	Description
OG000	Bi-Weekly Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
OG001	21-Day Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.

Units	Counts
Participants

Secondary

Overall Survival

Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12).

Posted

Median

Full Range

months

ID	Title	Description
OG000	Bi-Weekly Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.
OG001	21-Day Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0010 events0 affected21 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0005 events4 affected52 at risk EG0011 events1 affected21 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Constipation	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Pyrexia	General disorders	MedDRA 10	Systematic Assessment	EG0003 events2 affected52 at risk EG0011 events1 affected21 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 10	Systematic Assessment	EG0002 events1 affected52 at risk EG0010 events0 affected21 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Device related infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Pneumonia	Infections and infestations	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0010 events0 affected21 at risk
Sepsis	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Drug level increased	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0010 events0 affected21 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Convulsion	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Dizziness	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Meningitis noninfective	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Mental status changes	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0010 events0 affected21 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected21 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk
Aortic stenosis	Vascular disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected21 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG00040 events23 affected52 at risk EG00122 events12 affected21 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0013 events3 affected21 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG00018 events13 affected52 at risk EG00122 events6 affected21 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0002 events1 affected52 at risk EG00110 events2 affected21 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG00035 events23 affected52 at risk EG00153 events16 affected21 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0013 events2 affected21 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG00014 events10 affected52 at risk EG00120 events8 affected21 at risk
Tachycardia	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0005 events5 affected52 at risk EG0011 events1 affected21 at risk
Diplopia	Eye disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0014 events2 affected21 at risk
Eye irritation	Eye disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected52 at risk EG0014 events3 affected21 at risk
Eye swelling	Eye disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected21 at risk
Lacrimation increased	Eye disorders	MedDRA 10	Systematic Assessment	EG0009 events8 affected52 at risk EG0011 events1 affected21 at risk
Vision blurred	Eye disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected21 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected21 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0007 events5 affected52 at risk EG0013 events3 affected21 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00013 events10 affected52 at risk EG0016 events5 affected21 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0006 events5 affected52 at risk EG0010 events0 affected21 at risk
Constipation	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00040 events26 affected52 at risk EG00111 events6 affected21 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00018 events16 affected52 at risk EG00114 events12 affected21 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0006 events3 affected52 at risk EG0010 events0 affected21 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0005 events5 affected52 at risk EG0013 events3 affected21 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0006 events6 affected52 at risk EG0010 events0 affected21 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0012 events2 affected21 at risk
Nausea	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00046 events28 affected52 at risk EG00128 events14 affected21 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00012 events9 affected52 at risk EG0014 events3 affected21 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG00013 events10 affected52 at risk EG00116 events7 affected21 at risk
Asthenia	General disorders	MedDRA 10	Systematic Assessment	EG0009 events6 affected52 at risk EG0016 events4 affected21 at risk
Chest discomfort	General disorders	MedDRA 10	Systematic Assessment	EG0005 events3 affected52 at risk EG0012 events1 affected21 at risk
Chest pain	General disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected52 at risk EG0015 events4 affected21 at risk
Chills	General disorders	MedDRA 10	Systematic Assessment	EG0009 events7 affected52 at risk EG0017 events6 affected21 at risk
Face oedema	General disorders	MedDRA 10	Systematic Assessment	EG0004 events4 affected52 at risk EG0010 events0 affected21 at risk
Fatigue	General disorders	MedDRA 10	Systematic Assessment	EG00068 events35 affected52 at risk EG00128 events15 affected21 at risk
Feeling hot	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events2 affected21 at risk
Mucosal inflammation	General disorders	MedDRA 10	Systematic Assessment	EG0007 events6 affected52 at risk EG0014 events4 affected21 at risk
Oedema	General disorders	MedDRA 10	Systematic Assessment	EG0006 events5 affected52 at risk EG0011 events1 affected21 at risk
Oedema peripheral	General disorders	MedDRA 10	Systematic Assessment	EG00015 events12 affected52 at risk EG0015 events4 affected21 at risk
Pain	General disorders	MedDRA 10	Systematic Assessment	EG0006 events5 affected52 at risk EG0014 events3 affected21 at risk
Pyrexia	General disorders	MedDRA 10	Systematic Assessment	EG00023 events15 affected52 at risk EG00125 events14 affected21 at risk
Hypersensitivity	Immune system disorders	MedDRA 10	Systematic Assessment	EG0004 events3 affected52 at risk EG0010 events0 affected21 at risk
Cellulitis	Infections and infestations	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected21 at risk
Sinusitis	Infections and infestations	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0012 events2 affected21 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0007 events5 affected52 at risk EG0013 events3 affected21 at risk
Urinary tract infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0006 events4 affected52 at risk EG0011 events1 affected21 at risk
Alanine aminotransferase increased	Investigations	MedDRA 10	Systematic Assessment	EG00015 events12 affected52 at risk EG00117 events7 affected21 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 10	Systematic Assessment	EG00017 events14 affected52 at risk EG00119 events9 affected21 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 10	Systematic Assessment	EG0006 events6 affected52 at risk EG0017 events5 affected21 at risk
Haemoglobin decreased	Investigations	MedDRA 10	Systematic Assessment	EG0005 events4 affected52 at risk EG0017 events2 affected21 at risk
Neutrophil count decreased	Investigations	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0014 events4 affected21 at risk
Weight decreased	Investigations	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected21 at risk
White blood cell count decreased	Investigations	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0015 events3 affected21 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG00011 events10 affected52 at risk EG00112 events8 affected21 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0003 events2 affected52 at risk EG0012 events2 affected21 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0012 events2 affected21 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG00016 events11 affected52 at risk EG00110 events2 affected21 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0014 events2 affected21 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0016 events2 affected21 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0009 events6 affected52 at risk EG0019 events6 affected21 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0005 events4 affected52 at risk EG0014 events3 affected21 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG00011 events9 affected52 at risk EG00113 events6 affected21 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0008 events8 affected52 at risk EG0016 events5 affected21 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0004 events3 affected52 at risk EG0013 events3 affected21 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events2 affected21 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0006 events6 affected52 at risk EG0012 events1 affected21 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0005 events3 affected52 at risk EG0014 events4 affected21 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG00014 events7 affected52 at risk EG00116 events5 affected21 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0005 events4 affected52 at risk EG0017 events6 affected21 at risk
Dizziness	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0015 events4 affected21 at risk
Dysgeusia	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0008 events5 affected52 at risk EG0012 events2 affected21 at risk
Headache	Nervous system disorders	MedDRA 10	Systematic Assessment	EG00017 events11 affected52 at risk EG00112 events11 affected21 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0013 events3 affected21 at risk
Lethargy	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0013 events2 affected21 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0013 events3 affected21 at risk
Paraesthesia	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0014 events3 affected21 at risk
Sinus headache	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events2 affected21 at risk
Somnolence	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events2 affected21 at risk
Tremor	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected21 at risk
Anxiety	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0006 events6 affected52 at risk EG0014 events3 affected21 at risk
Confusional state	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0005 events4 affected52 at risk EG0010 events0 affected21 at risk
Insomnia	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0009 events9 affected52 at risk EG0013 events3 affected21 at risk
Dysuria	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0011 events1 affected21 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0012 events2 affected21 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG00015 events14 affected52 at risk EG0019 events7 affected21 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG00020 events15 affected52 at risk EG00110 events6 affected21 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0006 events5 affected52 at risk EG0010 events0 affected21 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0005 events5 affected52 at risk EG0012 events2 affected21 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected21 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected21 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0005 events3 affected52 at risk EG0014 events4 affected21 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0019 events5 affected21 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected52 at risk EG0013 events2 affected21 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected52 at risk EG0015 events2 affected21 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0008 events8 affected52 at risk EG0013 events3 affected21 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0006 events5 affected52 at risk EG0011 events1 affected21 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0006 events5 affected52 at risk EG0019 events4 affected21 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0005 events5 affected52 at risk EG0013 events3 affected21 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG00010 events9 affected52 at risk EG0016 events4 affected21 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG00030 events23 affected52 at risk EG00118 events15 affected21 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0004 events3 affected52 at risk EG0011 events1 affected21 at risk
Flushing	Vascular disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected52 at risk EG0016 events6 affected21 at risk
Lymphoedema	Vascular disorders	MedDRA 10	Systematic Assessment	EG0009 events6 affected52 at risk EG0012 events2 affected21 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bi-Weekly Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression. Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.			17		51
EG001	21-Day Schedule	Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression. Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.			7		21