A Study of Tarceva (Erlotinib) in Combination With Platin... | NCT01998919

Label	Type	Description	Intervention Names
Tarceva + gemcitabine/platinum	Experimental		Drug: erlotinib [Tarceva] Drug: gemcitabine Drug: cisplatin Drug: carboplatin
Placebo + gemcitabine/platinum	Placebo Comparator		Drug: placebo Drug: gemcitabine Drug: cisplatin Drug: carboplatin

Name	Type	Description	Arm Group Labels	Other Names
erlotinib [Tarceva]	Drug	150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily	Tarceva + gemcitabine/platinum

Measure	Description	Time Frame
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)	Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.	Week 8

Measure	Description	Time Frame
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST	Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.	Week 16
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

ID	Title	Description
FG000	Placebo Plus Chemotherapy	Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 times [x] area under the serum concentration-time curve [AUC]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.

ID	Title	Description
BG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
BG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00078 BG00176 BG002154

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

Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.

FAS; for analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
OG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.

Units	Counts
Participants	OG00078 OG00176

Title

Denominators

Categories

Title	Measurements
	OG00076.9(66.0 to 85.7) OG00180.3(69.5 to 88.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Mean Difference (Final Values)	3.34			2-Sided	95	-10.3	17.0			Approximate 95% CI for difference of two rates using Hauck-Anderson method.	No	Superiority or Other

Secondary

Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST

Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

Week 16

ID	Title	Description
OG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
OG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.

Secondary

Percentage of Participants With Confirmed CR or PR as Assessed by RECIST

CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases

ID	Title	Description
OG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
OG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.

Secondary

Duration of Response

Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.

FAS; only participants with CR or PR were included in the analysis.

Posted

Median

95% Confidence Interval

weeks

Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases

ID	Title	Description
OG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
OG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.

Secondary

Time to Progression

Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.

FAS Population

Posted

Median

95% Confidence Interval

weeks

Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases

ID	Title	Description
OG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
OG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.

Secondary

Progression-Free Survival (PFS)

PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.

FAS Population

Posted

Median

95% Confidence Interval

weeks

Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases

ID	Title	Description
OG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
OG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.

Secondary

Overall Survival

Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.

FAS Population

Posted

Median

95% Confidence Interval

weeks

Date of randomization until date of death or date of last follow-up assessment

ID	Title	Description
OG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
OG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG00019 affected79 at risk EG00120 affected74 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0007 affected79 at risk EG00117 affected74 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0006 affected79 at risk EG00110 affected74 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00037 affected79 at risk EG00134 affected74 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00029 affected79 at risk EG00122 affected74 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00025 affected79 at risk EG00122 affected74 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00020 affected79 at risk EG00126 affected74 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0019 affected74 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0015 affected74 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0015 affected74 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0016 affected74 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG00033 affected79 at risk EG00130 affected74 at risk
Fatigue	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00018 affected79 at risk EG00123 affected74 at risk
Pyrexia	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00011 affected79 at risk EG00110 affected74 at risk
Chest pain	General disorders	MedDRA 12.1	Non-systematic Assessment	EG00010 affected79 at risk EG0015 affected74 at risk
Asthenia	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0005 affected79 at risk EG0015 affected74 at risk
Mucosal inflammation	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0016 affected74 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG00012 affected79 at risk EG00119 affected74 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG00017 affected79 at risk EG00117 affected74 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0006 affected79 at risk EG0016 affected74 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0014 affected74 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG00014 affected79 at risk EG00114 affected74 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0008 affected79 at risk EG0016 affected74 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0005 affected79 at risk EG0014 affected74 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0016 affected74 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0015 affected74 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0014 affected74 at risk
Insomnia	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG00011 affected79 at risk EG0019 affected74 at risk
Platelet count decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0005 affected79 at risk EG0017 affected74 at risk
White blood cell count decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0007 affected79 at risk EG0015 affected74 at risk
Neutrophil count decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0005 affected79 at risk EG0016 affected74 at risk
Haemoglobin decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0016 affected74 at risk
Dizziness	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0006 affected79 at risk EG0017 affected74 at risk
Dysgeusia	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0015 affected74 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0014 affected74 at risk
Paronychia	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0017 affected74 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0006 affected79 at risk EG0017 affected74 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0007 affected79 at risk EG0014 affected74 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0014 affected74 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0013 affected74 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0014 affected74 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0013 affected74 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0011 affected74 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG00032 affected79 at risk EG00148 affected74 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0018 affected74 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0019 affected74 at risk
Malaise	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0007 affected79 at risk EG0012 affected74 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0006 affected79 at risk EG0013 affected74 at risk
Alanine aminotransferase increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0008 affected79 at risk EG0013 affected74 at risk
White blood cell count	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0006 affected79 at risk EG0012 affected74 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0005 affected79 at risk EG0012 affected74 at risk
Neutrophil count	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0011 affected74 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0006 affected79 at risk EG0011 affected74 at risk
Headache	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0009 affected79 at risk EG0013 affected74 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0012 affected74 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0006 affected79 at risk EG0013 affected74 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0012 affected74 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0013 affected74 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 12.1	Non-systematic Assessment	EG0004 affected79 at risk EG0011 affected74 at risk
Deafness	Ear and labyrinth disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Ear disorder	Ear and labyrinth disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Dysuria	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Proteinuria	Renal and urinary disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Palpitations	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0012 affected74 at risk
Angina pectoris	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Arrhythmia	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Tachycardia	Cardiac disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected74 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Breast swelling	Reproductive system and breast disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Hypersensitivity	Immune system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Dry eye	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0013 affected74 at risk
Vision blurred	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0011 affected74 at risk
Conjunctivitis	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected74 at risk
Abnormal sensation in eye	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Eye pain	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Eye pruritus	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Eyelid oedema	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Lacrimation increased	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Meibomian gland dysfunction	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Visual impairment	Eye disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Hypotension	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Flushing	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Hot flush	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Thrombosis	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Vasculitis	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Vein pain	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0011 affected74 at risk
Pneumonia	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0011 affected74 at risk
Infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Nail infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected74 at risk
Oral herpes	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Abscess limb	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Candidiasis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Cellulitis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Herpes virus infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Laryngitis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Oral candidiasis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Pharyngitis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Sepsis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Tinea infection	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Tinea versicolour	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Tonsillitis	Infections and infestations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Anxiety	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0011 affected74 at risk
Depression	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Delirium	Psychiatric disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0011 affected74 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0013 affected74 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected74 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0011 affected74 at risk
Somnolence	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Cognitive disorder	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Disturbance in attention	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Paraesthesia	Nervous system disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Blood creatinine increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0011 affected74 at risk
Platelet count	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0011 affected74 at risk
Blood sodium decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Haemoglobin	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Hepatic enzyme increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Weight decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Weight increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Alanine aminotransferase	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Aspartate aminotransferase	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Blood albumin decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Blood bilirubin increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Blood creatinine abnormal	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Blood potassium decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Blood pressure increased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Liver function test abnormal	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Neutrophil percentage decreased	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Sputum abnormal	Investigations	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0013 affected74 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0013 affected74 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Pharyngeal ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Chest discomfort	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0013 affected74 at risk
Pain	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0012 affected74 at risk
Chills	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0012 affected74 at risk
Influenza like illness	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0012 affected74 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0012 affected74 at risk
Oedema	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Catheter site swelling	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Discomfort	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Face oedema	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Gait disturbance	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Local swelling	General disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0011 affected74 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0010 affected74 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0013 affected74 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0012 affected74 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected74 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Dyshidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Toothache	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0013 affected74 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0012 affected74 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0012 affected74 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0013 affected74 at risk
Glossitis	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected74 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Parotid gland enlargement	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Tooth socket haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Campbelltown		2560	Australia

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D000069347	Erlotinib Hydrochloride
D000093542	Gemcitabine
D002945	Cisplatin
D016190	Carboplatin

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Plus Chemotherapy	Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.			17	79	74	79
EG001	Erlotinib Plus Chemotherapy	Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.			17	74	73	74

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0005 affected79 at risk EG0015 affected74 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Pneumonia	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected74 at risk
Diverticulitis	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Infection	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Lymphangitis	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Pyelonephritis acute	Infections and infestations	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Nausea	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected74 at risk
Constipation	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0003 affected79 at risk EG0011 affected74 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Fatigue	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Pain	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Pyrexia	General disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0011 affected74 at risk
Cerebral infarction	Nervous system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA version 12.1	Non-systematic Assessment	EG0001 affected79 at risk EG0010 affected74 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Myocardial infarction	Cardiac disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk
Renal Impairment	Renal and urinary disorders	MedDRA version 12.1	Non-systematic Assessment	EG0000 affected79 at risk EG0011 affected74 at risk