Chemotherapy Treatment in Re-occurring Non Small Cell Lun... | NCT00356525

ID	Type	Description	Link
H3E-US-S082	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Less Than One Year: Pemetrexed	Experimental	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy	Drug: pemetrexed Drug: gemcitabine
Less Than One Year: Pemetrexed + Gemcitabine	Experimental	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy	Drug: Pemetrexed
One Year or Greater: Pemetrexed + Carboplatin	Experimental	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy	Drug: carboplatin Drug: Pemetrexed
One Year or Greater: Pemetrexed + Gemcitabine	Experimental	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy	Drug: pemetrexed Drug: gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
pemetrexed	Drug	500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression	Less Than One Year: Pemetrexed One Year or Greater: Pemetrexed + Gemcitabine

Measure	Description	Time Frame
Objective Tumor Response	Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.	baseline to time of response (up to 17.5 months)

Measure	Description	Time Frame
Overall Survival	Overall survival is the number of participants who were alive when the trial was terminated.	baseline to trial termination (17.5 months)
Time to Progressive Disease		baseline to measured progressive disease (up to 17.5 months)

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM 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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Miami	Florida	33179

ID	Title	Description
FG000	Less Than One Year: Pemetrexed	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
FG001	Less Than One Year: Pemetrexed + Gemcitabine

ID	Title	Description
BG000	Less Than One Year: Pemetrexed	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
BG001	Less Than One Year: Pemetrexed + Gemcitabine	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
BG002	One Year or Greater: Pemetrexed + Carboplatin	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
BG003	One Year or Greater: Pemetrexed + Gemcitabine	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00014 BG00111 BG0027 BG0039 BG00441

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00010 events6 affected14 at risk EG00115 events10 affected11 at risk EG0023 events1 affected7 at risk EG0036 events3 affected9 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0014 events3 affected11 at risk EG0020 events0 affected7 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0005 events3 affected14 at risk EG0014 events4 affected11 at risk EG0028 events2 affected7 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected14 at risk EG0012 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0012 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Cardiac flutter	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Cardiac valve disease	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0014 events4 affected11 at risk EG0021 events1 affected7 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Palpitations	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Porokeratosis	Congenital, familial and genetic disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Hearing impaired	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Cataract	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Eye allergy	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Eye pruritus	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Glaucoma	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Macular degeneration	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Vision blurred	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0022 events1 affected7 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected14 at risk EG0016 events6 affected11 at risk EG0024 events3 affected7 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0023 events3 affected7 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0008 events7 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00015 events9 affected14 at risk EG00110 events6 affected11 at risk EG0027 events3 affected7 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0022 events1 affected7 at risk EG003
Reflux gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected14 at risk EG0014 events4 affected11 at risk EG0022 events1 affected7 at risk EG003
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0003 events2 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Chest discomfort	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Chills	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Face oedema	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG00017 events11 affected14 at risk EG00121 events11 affected11 at risk EG0027 events5 affected7 at risk EG003
Gait disturbance	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Malaise	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Mucosal dryness	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Mucosal inflammation	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0021 events1 affected7 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0003 events2 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Oedema	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0013 events3 affected11 at risk EG0021 events1 affected7 at risk EG003
Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0005 events3 affected14 at risk EG0017 events5 affected11 at risk EG0020 events0 affected7 at risk EG003
Secretion discharge	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0013 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Candidiasis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Empyema	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Collapse of lung	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Aspiration pleural cavity	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Blood creatinine increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Blood glucose increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Cardiac murmur	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Glomerular filtration rate abnormal	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Platelet count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Prothrombin time ratio	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Sputum culture positive	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Troponin increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
White blood cell count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0021 events1 affected7 at risk EG003
White blood cell count increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected14 at risk EG0013 events2 affected11 at risk EG0024 events2 affected7 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0005 events4 affected14 at risk EG0017 events4 affected11 at risk EG0022 events2 affected7 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected11 at risk EG0021 events1 affected7 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0003 events2 affected14 at risk EG0013 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected14 at risk EG0013 events3 affected11 at risk EG0021 events1 affected7 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0021 events1 affected7 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0013 events3 affected11 at risk EG0020 events0 affected7 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected11 at risk EG0021 events1 affected7 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0011 events1 affected11 at risk EG0022 events2 affected7 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Anosmia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Ataxia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected14 at risk EG0012 events2 affected11 at risk EG0021 events1 affected7 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0013 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Migraine	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0016 events5 affected11 at risk EG0020 events0 affected7 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0023 events1 affected7 at risk EG003
Radial nerve palsy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Sciatica	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Sedation	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Syncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Tremor	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected14 at risk EG0019 events4 affected11 at risk EG0021 events1 affected7 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0019 events6 affected11 at risk EG0021 events1 affected7 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0014 events4 affected11 at risk EG0022 events2 affected7 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0013 events3 affected11 at risk EG0022 events2 affected7 at risk EG003
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0014 events4 affected11 at risk EG0020 events0 affected7 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected14 at risk EG0014 events4 affected11 at risk EG0026 events4 affected7 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0008 events8 affected14 at risk EG0017 events6 affected11 at risk EG0025 events4 affected7 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 events2 affected14 at risk EG0012 events2 affected11 at risk EG0022 events1 affected7 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected11 at risk EG0020 events0 affected7 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0022 events1 affected7 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected11 at risk EG0021 events1 affected7 at risk EG003
Increased tendency to bruise	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Periorbital oedema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0013 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected14 at risk EG0017 events3 affected11 at risk EG0023 events2 affected7 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0012 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0021 events1 affected7 at risk EG003
Mechanical ventilation	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Thoracotomy	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Flushing	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected14 at risk EG0011 events1 affected11 at risk EG0020 events0 affected7 at risk EG003
Haematoma	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0022 events1 affected7 at risk EG003
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected14 at risk EG0016 events6 affected11 at risk EG0025 events5 affected7 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected11 at risk EG0021 events1 affected7 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003
Phlebitis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected11 at risk EG0020 events0 affected7 at risk EG003

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract 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
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Less Than One Year: Pemetrexed	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression	3	14	14	14
EG001	Less Than One Year: Pemetrexed + Gemcitabine	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression	5	11	11	11
EG002	One Year or Greater: Pemetrexed + Carboplatin	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression	0	7	7	7
EG003	One Year or Greater: Pemetrexed + Gemcitabine	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression	2	9	9	9