A Phase III Trial For Patients With Metastatic Breast Cancer | NCT00191152

ID	Type	Description	Link
B9E-US-S188

Label	Type	Description	Intervention Names
Gemcitabine + Docetaxel	Experimental		Drug: gemcitabine Drug: docetaxel
Capecitabine + Docetaxel	Active Comparator		Drug: docetaxel Drug: capecitabine

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine	Drug	1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression	Gemcitabine + Docetaxel

Measure	Description	Time Frame
Time to Disease Progression (Initial Treatment)	Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.	Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)

Measure	Description	Time Frame
Time to Disease Progression (Crossover Treatment)	For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.

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 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.		Glendale	Arizona

PubMed Identifier	Type	Citation	Retractions
34037241	Derived	Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

ID	Title	Description
FG000	Gemcitabine Plus Docetaxel	Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2),intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. PD during crossover was defined as the Response Evaluation Criteria in Solid Tumors (RECIST) guideline with the tumor measurement at the start of crossover treatment (or end of initial treatment) considered as the crossover baseline, with subsequent tumor measurements during crossover treatment compared to the crossover baseline.

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

Secondary

Time to Disease Progression (Crossover Treatment)

For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.

ITT population: all randomized participants. Censored participants in crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.

Posted

Median

95% Confidence Interval

months

Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)

ID	Title	Description
OG000	Capecitabine	capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
OG001	Gemcitabine	gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Units	Counts
Participants	OG00077 OG00181

Title

Denominators

Categories

Title	Measurements
	OG0004.51(2.11 to 7.80) OG0012.34(2.04 to 3.78)

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		0.145							95						No	Superiority or Other

Secondary

Progression-Free Survival (Initial Treatment)

For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.

ITT: all randomized participants. Censored participants (initial treatment): 64 in gemcitabine/docetaxel arm; 80 in docetaxel/capecitabine arm.

Posted

Median

95% Confidence Interval

months

Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)

ID	Title	Description
OG000	Gemcitabine Plus Docetaxel	gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
OG001	Docetaxel Plus Capecitabine	docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.

Secondary

Progression-Free Survival (Crossover Treatment)

For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.

ITT population: all randomized participants. Censored participants, crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.

Posted

Median

95% Confidence Interval

months

First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)

ID	Title	Description
OG000	Capecitabine	capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
OG001	Gemcitabine	gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Primary

Time to Disease Progression (Initial Treatment)

Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.

Intent-to-treat (ITT) population: all randomized participants. Censored participants in initial treatment: 68 gemcitabine/docetaxel arm; 83 docetaxel/capecitabine arm.

Posted

Median

95% Confidence Interval

months

Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)

ID	Title	Description
OG000	Gemcitabine Plus Docetaxel	gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
OG001	Docetaxel Plus Capecitabine	docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.

Secondary

Duration of Response (Initial Treatment)

Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.

ITT population: participants with CR or PR as best overall response (initial treatment). Censored participants: 16 in gemcitabine/docetaxel arm; 30 in docetaxel/capecitabine arm.

Posted

Median

95% Confidence Interval

months

Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)

ID	Title	Description
OG000	Gemcitabine Plus Docetaxel	gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
OG001	Docetaxel Plus Capecitabine	docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.

Secondary

Duration of Response (Crossover Treatment)

At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.

ITT population: participants with CR or PR as best overall response at crossover treatment. Censored participants: 4 in capecitabine arm; 2 in gemcitabine arm.

Posted

Median

95% Confidence Interval

months

Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)

ID	Title	Description
OG000	Capecitabine	capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
OG001	Gemcitabine	gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Secondary

Overall Survival

Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.

Intent to treat population: all randomized participant. Censored participants: 75 in gemcitabine/docetaxel arm; 72 in docetaxel/capecitabine arm.

Posted

Median

95% Confidence Interval

months

Date of randomization to date of death from any cause (up to 82 months)

ID	Title	Description
OG000	Gemcitabine Plus Docetaxel	gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
OG001	Docetaxel Plus Capecitabine	docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.

Units	Counts
Participants

Secondary

Best Overall Response (Initial Treatment)

Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.

ITT population.

Posted

Number

participants

Best response from start of treatment until disease progression/recurrence (up to 82 months)

ID	Title	Description
OG000	Gemcitabine Plus Docetaxel	gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
OG001	Docetaxel Plus Capecitabine	docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.

Secondary

Best Overall Response (Crossover Treatment)

Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.

Only included participants who crossed over from initial treatment to crossover treatment.

Posted

Number

participants

Best response from start of treatment until disease progression/recurrence (up to 82 months)

ID	Title	Description
OG000	Capecitabine	capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
OG001	Gemcitabine	gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Units	Counts

Secondary

Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)

KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).

Intent-to-treat population, initial treatment, participants with KPS at baseline and end of initial treatment.

Posted

Mean

Standard Deviation

units on a scale

Baseline until crossover treatment began (up to 82 months)

ID	Title	Description
OG000	Gemcitabine Plus Docetaxel	gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
OG001	Docetaxel Plus Capecitabine	docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.

Units	Counts
Participants

Secondary

Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)

KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).

Participants with KPS at baseline (conclusion of initial treatment) and end of crossover treatment

Posted

Mean

Standard Deviation

units on a scale

First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)

ID	Title	Description
OG000	Capecitabine	capecitabine 1000 mg/m2, by mouth two times per day, days 1-14, every 21 days
OG001	Gemcitabine	gemcitabine 1000 mg/m2 intravenously, days 1 and 8, every 21 days

Units	Counts
Participants	OG000

Secondary

Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)

RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].

Participants with RSCL at baseline and end of initial treatment.

Posted

Mean

Standard Deviation

units on a scale

Baseline until crossover treatment began (up to 82 months)

ID	Title	Description
OG000	Gemcitabine Plus Docetaxel	gemcitabine 1000 mg/m2, intravenous, on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, on Day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
OG001	Docetaxel Plus Capecitabine	docetaxel 75 mg/m2, intravenous on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth, twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.

Secondary

Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)

Participants with RSCL at baseline (conclusion of initial treatment)and end of crossover treatment

Posted

Mean

Standard Deviation

units on a scale

First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)

ID	Title	Description
OG000	Capecitabine	capecitabine 1000 mg/m2, by mouth twice day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
OG001	Gemcitabine	gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0011 events1 affected226 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG00010 events9 affected237 at risk EG0019 events9 affected226 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0009 events6 affected237 at risk EG0013 events2 affected226 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG00038 events25 affected237 at risk EG00111 events7 affected226 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected226 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected226 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Pericardial effusion	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected237 at risk EG0010 events0 affected226 at risk
Tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected226 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0014 events4 affected226 at risk
Diverticulitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events1 affected237 at risk EG0010 events0 affected226 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0012 events2 affected226 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Ruptured diverticulum	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Volvulus of bowel	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected237 at risk EG0013 events3 affected226 at risk
Asthenia	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Catheter site erythema	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected237 at risk EG0012 events2 affected226 at risk
Lethargy	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Malaise	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Mucosal inflammation	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Multi-organ failure	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected237 at risk EG0015 events5 affected226 at risk
Bronchopneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Catheter related infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Catheter sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Catheter site infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected226 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0013 events3 affected226 at risk
Cellulitis orbital	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Clostridium colitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected226 at risk
Escherichia infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0013 events3 affected226 at risk
Lobar pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected226 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected237 at risk EG0013 events3 affected226 at risk
Pyelonephritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected226 at risk
Septic shock	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0010 events0 affected226 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0011 events1 affected226 at risk
Urosepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Haematocrit decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0011 events1 affected226 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected237 at risk EG0012 events2 affected226 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected237 at risk EG0012 events2 affected226 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0011 events1 affected226 at risk
Bilateral hydronephrosis	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Renal insufficiency	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected237 at risk EG0010 events0 affected226 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Chronic obstructive airways disease exacerbated	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 events1 affected237 at risk EG0010 events0 affected226 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected237 at risk EG0012 events2 affected226 at risk
Dyspnoea exacerbated	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0012 events2 affected226 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0011 events1 affected226 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected237 at risk EG0011 events1 affected226 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected237 at risk EG0010 events0 affected226 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0014 events4 affected226 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0012 events2 affected226 at risk
Embolism	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Phlebothrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Shock	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0011 events1 affected226 at risk
Thrombophlebitis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk
Thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected237 at risk EG0012 events2 affected226 at risk
Venous occlusion	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected237 at risk EG0010 events0 affected226 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG000278 events113 affected237 at risk EG001110 events59 affected226 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG000294 events86 affected237 at risk EG00153 events25 affected226 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG000883 events193 affected237 at risk EG001216 events73 affected226 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG000152 events70 affected237 at risk EG00113 events6 affected226 at risk
Lacrimation increased	Eye disorders	MedDRA 11.0	Systematic Assessment	EG00023 events15 affected237 at risk EG00138 events29 affected226 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00042 events33 affected237 at risk EG00143 events30 affected226 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000100 events65 affected237 at risk EG00171 events49 affected226 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000217 events111 affected237 at risk EG001221 events108 affected226 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00028 events21 affected237 at risk EG00144 events28 affected226 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000233 events113 affected237 at risk EG001248 events118 affected226 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00092 events47 affected237 at risk EG001113 events60 affected226 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000120 events71 affected237 at risk EG001134 events74 affected226 at risk
Asthenia	General disorders	MedDRA 11.0	Systematic Assessment	EG000104 events45 affected237 at risk EG00161 events32 affected226 at risk
Chest pain	General disorders	MedDRA 11.0	Systematic Assessment	EG00023 events15 affected237 at risk EG00113 events12 affected226 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG000285 events129 affected237 at risk EG001224 events120 affected226 at risk
Mucosal inflammation	General disorders	MedDRA 11.0	Systematic Assessment	EG00081 events38 affected237 at risk EG001117 events65 affected226 at risk
Oedema	General disorders	MedDRA 11.0	Systematic Assessment	EG00077 events31 affected237 at risk EG00146 events27 affected226 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG00090 events54 affected237 at risk EG00167 events44 affected226 at risk
Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG00045 events25 affected237 at risk EG00131 events18 affected226 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG00093 events60 affected237 at risk EG00138 events33 affected226 at risk
Rigors	General disorders	MedDRA 11.0	Systematic Assessment	EG00022 events15 affected237 at risk EG0019 events9 affected226 at risk
Candidiasis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0009 events5 affected237 at risk EG00114 events12 affected226 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00021 events17 affected237 at risk EG0018 events8 affected226 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00019 events13 affected237 at risk EG00111 events11 affected226 at risk
Alanine aminotransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG00042 events28 affected237 at risk EG00119 events13 affected226 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG00031 events21 affected237 at risk EG00122 events14 affected226 at risk
Weight decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG00023 events16 affected237 at risk EG00114 events10 affected226 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG000122 events59 affected237 at risk EG00192 events59 affected226 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00024 events21 affected237 at risk EG00126 events22 affected226 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00047 events21 affected237 at risk EG00121 events15 affected226 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00022 events10 affected237 at risk EG00117 events12 affected226 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00016 events13 affected237 at risk EG00117 events14 affected226 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00060 events43 affected237 at risk EG00162 events39 affected226 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00034 events24 affected237 at risk EG00131 events23 affected226 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00029 events21 affected237 at risk EG00112 events10 affected226 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG000105 events46 affected237 at risk EG00162 events33 affected226 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00042 events25 affected237 at risk EG00131 events25 affected226 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00024 events21 affected237 at risk EG00132 events19 affected226 at risk
Dysgeusia	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00050 events32 affected237 at risk EG00139 events29 affected226 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00053 events41 affected237 at risk EG00138 events32 affected226 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG000133 events78 affected237 at risk EG001141 events83 affected226 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00021 events16 affected237 at risk EG00110 events9 affected226 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00038 events31 affected237 at risk EG00137 events30 affected226 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00092 events54 affected237 at risk EG00155 events45 affected226 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00081 events55 affected237 at risk EG00151 events37 affected226 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00026 events20 affected237 at risk EG00117 events11 affected226 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG000120 events86 affected237 at risk EG001127 events98 affected226 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00010 events10 affected237 at risk EG00119 events15 affected226 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00070 events38 affected237 at risk EG001118 events67 affected226 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00020 events15 affected237 at risk EG001370 events129 affected226 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00016 events14 affected237 at risk EG00111 events10 affected226 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00082 events59 affected237 at risk EG00144 events32 affected226 at risk
Hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00013 events12 affected237 at risk EG0016 events6 affected226 at risk
Lymphoedema	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00024 events14 affected237 at risk EG00112 events10 affected226 at risk

ID	Title	Description
BG000	Gemcitabine Plus Docetaxel	Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO)twice a day (BID), Days 1-14, every 21 days until progressive disease (PD) at which time all treatment is discontinued.
BG001	Docetaxel Plus Capecitabine	Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID),Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued.
BG002	Total	Total of all reporting groups

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

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
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gemcitabine Plus Docetaxel	Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued.			72	237	233	237
EG001	Docetaxel Plus Capecitabine	Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins. Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued.			55	226	221	226

ID	Term
D000093542	Gemcitabine
D000077143	Docetaxel
D000069287	Capecitabine