Comparison of IV Topotecan/Docetaxel to Docetaxel Alone i... | NCT00065182

ID	Type	Description	Link
2004-002892-17	EudraCT Number

Name	Type	Description	Arm Group Labels	Other Names
Topotecan/Docetaxel combination	Drug
Docetaxel	Drug			Topotecan/Docetaxel combination

Measure	Description	Time Frame
Median Time of Overall Survival	Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.	Up to one year from Day -1 (randomization)

Measure	Description	Time Frame
Number of Participants With One-year Survival	Number of participants with one-year survival were planned to be reported.	Up to one year from Day -1 (randomization)
Median Time to Progression

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Huntsville	Alabama	35801	United States
GSK Investigational Site

ID	Title	Description
FG000	IV Topotecan + IV Docetaxel	Eligible participants received intravenous (IV) topotecan 3.5 milligrams per square meter per day (mg/m^2/day) and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

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

Median Time of Overall Survival

Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.

Intent-to-treat (ITT) population was defined as all participants randomized to one of the two treatment regimens.

Posted

Median

95% Confidence Interval

Weeks

Up to one year from Day -1 (randomization)

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Units	Counts
Participants	OG000202 OG001197

Title

Denominators

Categories

Title	Measurements
	OG00030.7(26.1 to 35.9) OG00128.6(23.6 to 36.4)

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		Log Rank		0.9460		Hazard Ratio (HR)	1.007			2-Sided	95	0.813	1.248			Unadjusted hazard ratio.		Superiority
OG000 OG001

Secondary

Number of Participants With One-year Survival

Number of participants with one-year survival were planned to be reported.

ITT population. Data was not collected for this outcome measure.

Posted

Up to one year from Day -1 (randomization)

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Units	Counts
Participants

Secondary

Median Time to Progression

Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression.

ITT population. Data was not collected for this outcome measure.

Posted

Up to one year from Day -1 (randomization)

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Units	Counts
Participants

Secondary

Response Rate

Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response.

ITT population. Data was not collected for this outcome measure.

Posted

Up to one year from Day -1 (randomization)

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Units	Counts
Participants

Secondary

Response Duration

Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression.

ITT population. Data was not collected for this outcome measure.

Posted

Up to one year from Day -1 (randomization)

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Units	Counts
Participants

Secondary

Time to Response-assessed Every 8 Weeks

Time to response is defined as the time between randomization and the first radiologically documented complete or partial response.

ITT population. Data was not collected for this outcome measure.

Posted

Every 8 Weeks post randomization

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Units	Counts
Participants

Secondary

Assessment of Quality of Life-assessed Every 4 Weeks

The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be).

ITT population. Data was not collected for this outcome measure.

Posted

Every 4 Weeks post randomization

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant.

mITT Population was defined as all participants who were randomized and received at least one dose of study medication.

Posted

Count of Participants

Participants

Up to 16 months

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Secondary

Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities

Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented.

mITT population. Only those participants available at the indicated time points were analyzed.

Posted

Count of Participants

Participants

Up to 16 months

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Secondary

Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities

Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented.

mITT population. Only those participants available at the indicated time points were analyzed.

Posted

Count of Participants

Participants

Up to 16 months

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Secondary

Number of Participants With Clinically Significant Abnormal Vital Signs Data

Vital sign parameters included (blood pressure, and pulse rate after five minutes sitting, body temperature). Blood pressure and pulse rate was measured after sitting for 5 minutes. Only participants with clinically significant abnormal Vital sign data was reported.

mITT population.

Posted

Count of Participants

Participants

Up to 16 months

ID	Title	Description
OG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
OG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.

Units

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0007 affected200 at risk EG0014 affected195 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected200 at risk EG0010 affected195 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected200 at risk EG0012 affected195 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected200 at risk EG0017 affected195 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0005 affected200 at risk EG0011 affected195 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected200 at risk EG0011 affected195 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected200 at risk EG0012 affected195 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected200 at risk EG0010 affected195 at risk
Bronchitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 affected200 at risk EG0010 affected195 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected200 at risk EG0010 affected195 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected200 at risk EG0011 affected195 at risk
Respiratory tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 affected200 at risk EG0011 affected195 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0011 affected195 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Asthenia	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Atrial flutter	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0011 affected195 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0011 affected195 at risk
Bronchopneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0011 affected195 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Catheter related complication	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Disease progression	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Electrocardiogram ST-T change	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Empyema	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Haemorrhage	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Infusion site phlebitis	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0012 affected195 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Pharyngitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0011 affected195 at risk
Pyrexia	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0011 affected195 at risk
Sepsis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0012 affected195 at risk
Shock	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0010 affected195 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected200 at risk EG0012 affected195 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0014 affected195 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0012 affected195 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0012 affected195 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Angina unstable	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Appendicitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Catheter site infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Cellulitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Clostridial infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Lobar pneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Mucosal inflammation	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Oedema	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Perforated ulcer	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Proctitis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected200 at risk EG0011 affected195 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 10.1	Systematic Assessment	EG00090 affected200 at risk EG00174 affected195 at risk
Oedema peripheral	General disorders	MedDRA 10.1	Systematic Assessment	EG00028 affected200 at risk EG00131 affected195 at risk
Pyrexia	General disorders	MedDRA 10.1	Systematic Assessment	EG00031 affected200 at risk EG00128 affected195 at risk
Asthenia	General disorders	MedDRA 10.1	Systematic Assessment	EG00019 affected200 at risk EG00121 affected195 at risk
Chest pain	General disorders	MedDRA 10.1	Systematic Assessment	EG00017 affected200 at risk EG00119 affected195 at risk
Oedema	General disorders	MedDRA 10.1	Systematic Assessment	EG0008 affected200 at risk EG00110 affected195 at risk
Mucosal inflammation	General disorders	MedDRA 10.1	Systematic Assessment	EG00011 affected200 at risk EG0016 affected195 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00057 affected200 at risk EG00143 affected195 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00051 affected200 at risk EG00140 affected195 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00039 affected200 at risk EG00138 affected195 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00026 affected200 at risk EG00122 affected195 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00012 affected200 at risk EG00111 affected195 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00012 affected200 at risk EG0018 affected195 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG00046 affected200 at risk EG00136 affected195 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG00031 affected200 at risk EG00129 affected195 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG00015 affected200 at risk EG0018 affected195 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG00010 affected200 at risk EG0019 affected195 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG00011 affected200 at risk EG0014 affected195 at risk
Headache	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG00024 affected200 at risk EG00120 affected195 at risk
Dysgeusia	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG00013 affected200 at risk EG00120 affected195 at risk
Dizziness	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG00021 affected200 at risk EG00110 affected195 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG00012 affected200 at risk EG0017 affected195 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0008 affected200 at risk EG00110 affected195 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG00044 affected200 at risk EG00121 affected195 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG00034 affected200 at risk EG0019 affected195 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG00022 affected200 at risk EG0012 affected195 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG00033 affected200 at risk EG00137 affected195 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG00017 affected200 at risk EG0018 affected195 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG00010 affected200 at risk EG00111 affected195 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG00036 affected200 at risk EG00135 affected195 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG00010 affected200 at risk EG00118 affected195 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0004 affected200 at risk EG00113 affected195 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0008 affected200 at risk EG00120 affected195 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00011 affected200 at risk EG00117 affected195 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0007 affected200 at risk EG00115 affected195 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0007 affected200 at risk EG00114 affected195 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00011 affected200 at risk EG0016 affected195 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected200 at risk EG00110 affected195 at risk
Insomnia	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG00019 affected200 at risk EG00128 affected195 at risk
Anxiety	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG00011 affected200 at risk EG00111 affected195 at risk
Confusional state	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG00010 affected200 at risk EG0013 affected195 at risk
Lacrimation increased	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0005 affected200 at risk EG00113 affected195 at risk
Hypotension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG00010 affected200 at risk EG0017 affected195 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
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
BG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IV Topotecan + IV Docetaxel	Eligible participants received IV topotecan 3.5 mg/m^2/day and IV docetaxel 30 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of every 28 day treatment cycle. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.	170	200	58	200	181	200
EG001	IV Docetaxel	Eligible participants received single-agent IV docetaxel administered either 75 mg/m^2/day Day 1 (±2 days) of each 21 day treatment cycle or 35 mg/m^2/day on Days 1, 8 and 15 (± 2 days) of each 28 day treatment cycle, based on the investigator's choice. Participants received at least 4 cycles of treatment unless disease progression was noted or the participant withdrew from the study.	165	195	49	195	166	195