Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin... | NCT00191139

ID	Type	Description	Link
B9E-US-S182	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Gemcitabine	Experimental		Drug: gemcitabine Drug: cisplatin Drug: etoposide Radiation: radiation therapy
Gemcitabine plus Docetaxel	Experimental		Drug: gemcitabine Drug: docetaxel Drug: cisplatin Drug: etoposide Radiation: radiation therapy

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine	Drug	After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.

Measure	Description	Time Frame
2-Year Survival	Percentage of participants alive at 2 years.	2 years

Measure	Description	Time Frame
Number of Patients With Overall Tumor Response	Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).

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 ph		Denver	Colorado	80218

ID	Title	Description
FG000	Gemcitabine	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
FG001	Gemcitabine Plus Docetaxel

ID	Title	Description
BG000	Gemcitabine	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
BG001	Gemcitabine Plus Docetaxel	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00032 BG00132 BG00264

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

2-Year Survival

Percentage of participants alive at 2 years.

Intention to treat (ITT) population

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Gemcitabine	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
OG001	Gemcitabine Plus Docetaxel	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.

Units	Counts
Participants	OG00032 OG00132

Title

Denominators

Categories

Title	Measurements
	OG00040.6 OG00155.7

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		normal approximation	Count the number of surviving participants at each time interval to get survival rates.			survival rate	40.6				95	23.8	56.8				No	Superiority or Other
OG001		normal approximation

Secondary

Number of Patients With Overall Tumor Response

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).

ITT population

Posted

Number

participants

randomization and every 3 months up to 2 years of post-study followup

ID	Title	Description
OG000	Gemcitabine	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
OG001	Gemcitabine Plus Docetaxel	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.

Units	Counts

Secondary

Progression-Free Survival

Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.

ITT population

Posted

Median

95% Confidence Interval

days

baseline to measured progressive disease up to 2057 days

ID	Title	Description
OG000	Gemcitabine	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
OG001	Gemcitabine Plus Docetaxel	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.

Units	Counts
Participants

Secondary

Overall Survival

Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.

ITT population

Posted

Median

95% Confidence Interval

days

baseline to date of death from any cause up to 2057 days

ID	Title	Description
OG000	Gemcitabine	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
OG001	Gemcitabine Plus Docetaxel	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.

Units	Counts
Participants	OG000

Secondary

Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization

LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.

as-treated population

Posted

Number

participants

baseline to 3 months after last dose of study treatment (three 21-day cycles)

ID	Title	Description
OG000	Gemcitabine	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
OG001	Gemcitabine Plus Docetaxel	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia NOS	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0018 events4 affected32 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0012 events2 affected32 at risk
Leukopenia NOS	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected32 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0017 events1 affected32 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0002 events1 affected32 at risk EG0016 events2 affected32 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Cardiac failure NOS	Cardiac disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0011 events1 affected32 at risk
Retinal detachment	Eye disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Diarrhoea NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected32 at risk
Diverticulitis NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Gastrointestinal haemorrhage NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Ileus	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0012 events2 affected32 at risk
Oesophagitis NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events1 affected32 at risk EG0013 events2 affected32 at risk
Vomiting NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0011 events1 affected32 at risk
Asthenia	General disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events1 affected32 at risk
Chest pain	General disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Death NOS	General disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected32 at risk
Fatigue	General disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Pyrexia	General disorders	MedDRA 6.0	Systematic Assessment	EG0002 events1 affected32 at risk EG0012 events2 affected32 at risk
Candidal infection NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Lung infection NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Pneumonia NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0005 events4 affected32 at risk EG0015 events5 affected32 at risk
Sepsis NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0010 events0 affected32 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0011 events1 affected32 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0014 events4 affected32 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Convulsions NOS	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected32 at risk
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Chronic obstructive airways disease exacerbated	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0012 events2 affected32 at risk
Pneumonitis NOS	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0013 events3 affected32 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Face oedema	Skin and subcutaneous tissue disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0011 events1 affected32 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia NOS	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG00026 events18 affected32 at risk EG00163 events24 affected32 at risk
Erythropenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0014 events2 affected32 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0013 events3 affected32 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0002 events1 affected32 at risk EG0014 events2 affected32 at risk
Leukopenia NOS	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG00041 events12 affected32 at risk EG00141 events13 affected32 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG0006 events4 affected32 at risk EG0016 events3 affected32 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG00093 events19 affected32 at risk EG00173 events23 affected32 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 6.0	Systematic Assessment	EG00027 events9 affected32 at risk EG00133 events13 affected32 at risk
Tachycardia NOS	Cardiac disorders	MedDRA 6.0	Systematic Assessment	EG0008 events7 affected32 at risk EG0015 events5 affected32 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 6.0	Systematic Assessment	EG0005 events5 affected32 at risk EG0013 events3 affected32 at risk
Vision blurred	Eye disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0013 events3 affected32 at risk
Abdominal pain NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0015 events5 affected32 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0015 events4 affected32 at risk
Constipation	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG00016 events13 affected32 at risk EG00125 events14 affected32 at risk
Diarrhoea NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG00015 events9 affected32 at risk EG00122 events16 affected32 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0005 events5 affected32 at risk EG00113 events9 affected32 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG00015 events11 affected32 at risk EG00119 events13 affected32 at risk
Flatulence	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected32 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0012 events1 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG00054 events23 affected32 at risk EG00162 events28 affected32 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0005 events3 affected32 at risk EG0013 events2 affected32 at risk
Oesophagitis NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG00011 events6 affected32 at risk EG00112 events9 affected32 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0004 events3 affected32 at risk EG0017 events5 affected32 at risk
Toothache	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG0003 events3 affected32 at risk EG0010 events0 affected32 at risk
Vomiting NOS	Gastrointestinal disorders	MedDRA 6.0	Systematic Assessment	EG00037 events17 affected32 at risk EG00147 events22 affected32 at risk
Asthenia	General disorders	MedDRA 6.0	Systematic Assessment	EG0005 events5 affected32 at risk EG0019 events5 affected32 at risk
Chest discomfort	General disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0012 events2 affected32 at risk
Chest pain	General disorders	MedDRA 6.0	Systematic Assessment	EG0008 events6 affected32 at risk EG0015 events4 affected32 at risk
Fatigue	General disorders	MedDRA 6.0	Systematic Assessment	EG00034 events19 affected32 at risk EG00159 events26 affected32 at risk
Influenza like illness	General disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0013 events2 affected32 at risk
Oedema NOS	General disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0018 events3 affected32 at risk
Oedema peripheral	General disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0016 events4 affected32 at risk
Pain NOS	General disorders	MedDRA 6.0	Systematic Assessment	EG0003 events3 affected32 at risk EG0013 events2 affected32 at risk
Pyrexia	General disorders	MedDRA 6.0	Systematic Assessment	EG00020 events10 affected32 at risk EG00122 events14 affected32 at risk
Rigors	General disorders	MedDRA 6.0	Systematic Assessment	EG0004 events3 affected32 at risk EG00110 events7 affected32 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 6.0	Systematic Assessment	EG0003 events3 affected32 at risk EG0014 events2 affected32 at risk
Candidal infection NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0002 events1 affected32 at risk EG0012 events2 affected32 at risk
Lower respiratory tract infection NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected32 at risk
Nasopharyngitis	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0012 events2 affected32 at risk
Pneumonia NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0004 events4 affected32 at risk EG0011 events1 affected32 at risk
Upper respiratory tract infection NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected32 at risk
Urinary tract infection NOS	Infections and infestations	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0012 events2 affected32 at risk
Dermatitis radiation NOS	Injury, poisoning and procedural complications	MedDRA 6.0	Systematic Assessment	EG0005 events4 affected32 at risk EG0015 events5 affected32 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 6.0	Systematic Assessment	EG0005 events4 affected32 at risk EG0012 events2 affected32 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 6.0	Systematic Assessment	EG0002 events1 affected32 at risk EG0014 events4 affected32 at risk
Alanine aminotransferase increased	Investigations	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0015 events2 affected32 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 6.0	Systematic Assessment	EG0005 events2 affected32 at risk EG0013 events2 affected32 at risk
Sputum increased	Investigations	MedDRA 6.0	Systematic Assessment	EG0003 events2 affected32 at risk EG0010 events0 affected32 at risk
Weight decreased	Investigations	MedDRA 6.0	Systematic Assessment	EG0005 events5 affected32 at risk EG0014 events4 affected32 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG00023 events16 affected32 at risk EG00131 events17 affected32 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG0006 events5 affected32 at risk EG0017 events5 affected32 at risk
Hyperglycaemia NOS	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG0003 events3 affected32 at risk EG00119 events6 affected32 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected32 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0017 events2 affected32 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG0005 events1 affected32 at risk EG0013 events3 affected32 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG00010 events5 affected32 at risk EG0019 events3 affected32 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 6.0	Systematic Assessment	EG0003 events2 affected32 at risk EG0013 events3 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 6.0	Systematic Assessment	EG0003 events3 affected32 at risk EG0016 events6 affected32 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 6.0	Systematic Assessment	EG0003 events3 affected32 at risk EG0011 events1 affected32 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0013 events2 affected32 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0012 events2 affected32 at risk
Local swelling	Musculoskeletal and connective tissue disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected32 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 6.0	Systematic Assessment	EG0004 events3 affected32 at risk EG0018 events7 affected32 at risk
Ataxia	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected32 at risk
Dizziness	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG0005 events3 affected32 at risk EG00115 events11 affected32 at risk
Dysgeusia	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG0005 events4 affected32 at risk EG0017 events7 affected32 at risk
Headache	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG00010 events7 affected32 at risk EG00110 events9 affected32 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected32 at risk
Peripheral neuropathy NOS	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected32 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG0004 events2 affected32 at risk EG0011 events1 affected32 at risk
Syncope	Nervous system disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0014 events4 affected32 at risk
Anxiety	Psychiatric disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0015 events5 affected32 at risk
Insomnia	Psychiatric disorders	MedDRA 6.0	Systematic Assessment	EG0008 events7 affected32 at risk EG0018 events6 affected32 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG00024 events17 affected32 at risk EG00122 events16 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG00018 events14 affected32 at risk EG00126 events16 affected32 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0015 events4 affected32 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0013 events3 affected32 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0012 events2 affected32 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0004 events4 affected32 at risk EG0017 events7 affected32 at risk
Pneumonitis NOS	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events1 affected32 at risk EG0012 events2 affected32 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0010 events0 affected32 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected32 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0000 events0 affected32 at risk EG0012 events2 affected32 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0002 events2 affected32 at risk EG0011 events1 affected32 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 6.0	Systematic Assessment	EG0003 events2 affected32 at risk EG0011 events1 affected32 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 6.0	Systematic Assessment	EG00016 events14 affected32 at risk EG00124 events20 affected32 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0012 events2 affected32 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 6.0	Systematic Assessment	EG0004 events3 affected32 at risk EG0014 events3 affected32 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 6.0	Systematic Assessment	EG0003 events2 affected32 at risk EG0010 events0 affected32 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 6.0	Systematic Assessment	EG0002 events1 affected32 at risk EG0015 events2 affected32 at risk
Rash NOS	Skin and subcutaneous tissue disorders	MedDRA 6.0	Systematic Assessment	EG0006 events2 affected32 at risk EG0013 events3 affected32 at risk
Sweating increased	Skin and subcutaneous tissue disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0014 events4 affected32 at risk
Hypotension NOS	Vascular disorders	MedDRA 6.0	Systematic Assessment	EG0005 events4 affected32 at risk EG00110 events7 affected32 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 6.0	Systematic Assessment	EG0001 events1 affected32 at risk EG0012 events2 affected32 at risk

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
D000093542	Gemcitabine
D000077143	Docetaxel
D002945	Cisplatin
D005047	Etoposide
C061400	etoposide phosphate
D011878	Radiotherapy

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D013812	Therapeutics

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gemcitabine	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles			13	32	32	32
EG001	Gemcitabine Plus Docetaxel	Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.			18	32	32	32