Phase III Study of Two Different Schedules (Weekly and Tr... | NCT00236899

NCT00236899

ID	Type	Description	Link
B9E-IT-S376	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A: Docetaxel and Gemcitabine (Tri-weekly)	Experimental	Docetaxel and Gemcitabine (Tri-weekly)	Drug: Gemcitabine Drug: Docetaxel
B: Paclitaxel and Gemcitabine (Tri-weekly)	Experimental	Paclitaxel and Gemcitabine (Tri-weekly)	Drug: Gemcitabine Drug: Paclitaxel
C: Docetaxel and Gemcitabine (Weekly)	Experimental	Docetaxel and Gemcitabine (Weekly)	Drug: Gemcitabine Drug: Docetaxel
D: Paclitaxel and Gemcitabine (Weekly)	Experimental	Paclitaxel and Gemcitabine (Weekly)	Drug: Gemcitabine Drug: Paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug	Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Progressive Disease (TTPD) by Treatment Schedule	TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.	Baseline up to 49.84 months
Time to Progressive Disease (TTPD) by Treatment Drug	TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.	Baseline up to 49.84 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) by Treatment Schedule	OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).	Baseline up to 51.64 months
Overall Survival (OS) by Treatment Drug

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Avellino		50019

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23537313	Derived	Del Mastro L, Fabi A, Mansutti M, De Laurentiis M, Durando A, Merlo DF, Bruzzi P, La Torre I, Ceccarelli M, Kazeem G, Marchi P, Boy D, Venturini M, De Placido S, Cognetti F. Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments. BMC Cancer. 2013 Mar 28;13:164. doi: 10.1186/1471-2407-13-164.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Docetaxel and Gemcitabine (Tri-weekly)	Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Arm A: Docetaxel and Gemcitabine (Tri-weekly)	Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
BG001	Arm B: Paclitaxel and Gemcitabine (Tri-weekly)	Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
BG002	Arm C: Docetaxel and Gemcitabine (Weekly)	Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
BG003	Arm D: Paclitaxel and Gemcitabine (Weekly)	Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.58± 10.21 BG00156.31± 9.84 BG00255.78± 8.99 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00060 BG00164 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00058 BG00163 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Italy

Title	Measurements
	BG00060 BG00164 BG002

Menopausal Status

Menopausal status is defined as the number of participants with premenopausal or postmenopausal status.

Number

participants

Title

Denominators

Categories

Premenopausal

Title	Measurements
	BG00019 BG00117 BG002

Previous Hormonal Therapy

Previous hormonal therapy status is defined as the number of participants who had previously received hormonal therapy.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00044 BG00148 BG002

Presence or Absence of Visceral Metastases

Visceral metastases are defined as any metastases to the major organs excluding bone, skin, soft tissue, and lymph nodes.

Number

participants

Title

Denominators

Categories

Absence

Title	Measurements
	BG00019 BG00119

Number of Participants with Previous Adjuvant/Neoadjuvant Taxane Therapy

This baseline measure presents the number of participants who had previously received adjuvant/neoadjuvant taxane therapy.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00021 BG00124

Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)

The RSSC is a valid and reliable instrument use to measure psychological and physical distress of cancer patients. The overall QOL of patients are assessed and categorized as: Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor.

Number

participants

Title

Denominators

Categories

Excellent

Title	Measurements
	BG0005 BG001

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

Time to Progressive Disease (TTPD) by Treatment Schedule

TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.

Intention to treat (ITT) population is defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 33 participants were censored with 16 (13.68%)in the Weekly arm and 17 (13.71%) participants in the 3 Weekly arm.

Posted

Median

95% Confidence Interval

months

Baseline up to 49.84 months

ID	Title	Description
OG000	Treatment Schedule (Weekly)	Arm C, Docetaxel and Gemcitabine (Weekly): Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D, Paclitaxel and Gemcitabine (Weekly): Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
OG001	Treatment Schedule (3 Weekly)	Arm A, Docetaxel and Gemcitabine (3 Weekly): Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm B, Paclitaxel and Gemcitabine (3 Weekly): Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Units	Counts
Participants	OG000117 OG001124

Title

Denominators

Categories

Title	Measurements
	OG0008.33(6.19 to 10.16) OG0017.51(5.93 to 8.33)

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		Regression, Cox		0.345		Hazard Ratio (HR)	1.14				95	0.87	1.50				No	Superiority or Other

Secondary

Overall Survival (OS) by Treatment Schedule

OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).

Intention to treat (ITT) population defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 109 (45.2%) participants were censored with 53 (45.3%) in the Weekly arm and 56 (45.2%) participants in the 3 Weekly arm.

Posted

Mean

95% Confidence Interval

months

Baseline up to 51.64 months

ID	Title	Description
OG000	Treatment Schedule (Weekly)	Arm C, Docetaxel and Gemcitabine (Weekly): Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D, Paclitaxel and Gemcitabine (Weekly): Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
OG001	Treatment Schedule (3 Weekly)

Secondary

Overall Survival (OS) by Treatment Drug

OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).

ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 109 participants were censored with 55 (46.61%) in the Docetaxel+Gemcitabine arm and 54 (43.90%) in the Paclitaxel+Gemcitabine arm.

Posted

Median

95% Confidence Interval

months

Baseline up to 51.64 months

ID	Title	Description
OG000	Treatment Drug (Docetaxel)	Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
OG001	Treatment Drug (Paclitaxel)	Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression.

Secondary

Overall Response Rate (ORR) by Treatment Schedule

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.

All randomized patients treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population.

Posted

Number

percentage of responses

Baseline up to 49.84 months

ID	Title	Description
OG000	Treatment Schedule (Weekly)	Arm C, Docetaxel and Gemcitabine (Weekly): Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D, Paclitaxel and Gemcitabine (Weekly): Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Primary

Time to Progressive Disease (TTPD) by Treatment Drug

ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 33 (13.7%) participants were censored with 17 (13.68%) in the Docetaxel+Gemcitabine arm and 18 (13.71%) in the Paclitaxel+Gemcitabine arm.

Posted

Median

95% Confidence Interval

months

Baseline up to 49.84 months

ID	Title	Description
OG000	Treatment Drug (Docetaxel)	Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Secondary

Overall Response Rate(ORR) by Treatment Drug

All randomized participants treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population.

Posted

Number

percentage of responses

Baseline up to 49.84 months

ID	Title	Description
OG000	Treatment Drug (Docetaxel)	Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Secondary

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

Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.

Intent to treat (ITT) population defined as the population of all randomized participants.

Posted

Number

participants

Baseline up to 51.64 months

ID	Title	Description
OG000	Arm A: Docetaxel and Gemcitabine (Tri-weekly)	Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
OG001	Arm B: Paclitaxel and Gemcitabine (Tri-weekly)	Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Secondary

Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle

RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.

Intent to treat (ITT) population defined as all randomized participants.

Posted

Number

participants

Baseline up to 51.64 months

ID	Title	Description
OG000	Arm A: Docetaxel and Gemcitabine (Tri-weekly)	Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
OG001

Secondary

Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit

Intent to treat (ITT) population defined as all randomized participants.

Posted

Number

participants

Baseline up to 51.64 months

ID	Title	Description
OG000	Arm A: Docetaxel and Gemcitabine (Tri-weekly)	Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
OG001	Arm B: Paclitaxel and Gemcitabine (Tri-weekly)	Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Docetaxel and Gemcitabine (Tri-weekly)	Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.	9	59	57	59
EG001	Arm B: Paclitaxel and Gemcitabine (Tri-weekly)	Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.	10	62	58	62
EG002	Arm C: Docetaxel and Gemcitabine (Weekly)	Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.	7	58	53	58
EG003	Arm D: Paclitaxel and Gemcitabine (Weekly)	Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.	11	59	56	59

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG0032 events2 affected59 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0012 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected59 at risk EG0010 events0 affected62 at risk EG0021 events1 affected58 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0021 events1 affected58 at risk EG003
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
General physical health deterioration	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0021 events1 affected58 at risk EG003
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0021 events1 affected58 at risk EG003
Device related infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0021 events1 affected58 at risk EG003
Meningitis pneumococcal	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0021 events1 affected58 at risk EG003
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Weight decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0021 events1 affected58 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0012 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Presyncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0021 events1 affected58 at risk EG003
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Femoral artery occlusion	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Vasculitis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0020 events0 affected58 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00019 events12 affected59 at risk EG00113 events10 affected62 at risk EG00215 events12 affected58 at risk EG00323 events17 affected59 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00041 events21 affected59 at risk EG00115 events9 affected62 at risk EG00235 events14 affected58 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0005 events3 affected59 at risk EG0013 events2 affected62 at risk EG0025 events3 affected58 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG000154 events50 affected59 at risk EG00185 events33 affected62 at risk EG00271 events20 affected58 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected59 at risk EG0016 events3 affected62 at risk EG00225 events10 affected58 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0012 events2 affected62 at risk EG0025 events4 affected58 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected59 at risk EG0017 events7 affected62 at risk EG0024 events3 affected58 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected59 at risk EG0014 events4 affected62 at risk EG0026 events5 affected58 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0008 events8 affected59 at risk EG00110 events9 affected62 at risk EG00216 events10 affected58 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00027 events18 affected59 at risk EG00113 events11 affected62 at risk EG00237 events21 affected58 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected59 at risk EG0010 events0 affected62 at risk EG0023 events2 affected58 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00038 events25 affected59 at risk EG00134 events21 affected62 at risk EG00234 events20 affected58 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00013 events10 affected59 at risk EG0014 events3 affected62 at risk EG00210 events8 affected58 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00018 events13 affected59 at risk EG00117 events10 affected62 at risk EG00217 events11 affected58 at risk EG003
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG00034 events17 affected59 at risk EG00128 events18 affected62 at risk EG00240 events18 affected58 at risk EG003
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG00018 events15 affected59 at risk EG00116 events12 affected62 at risk EG00224 events13 affected58 at risk EG003
Influenza like illness	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected62 at risk EG0023 events3 affected58 at risk EG003
Mucosal inflammation	General disorders	MedDRA 13.1	Systematic Assessment	EG00026 events17 affected59 at risk EG0018 events7 affected62 at risk EG00211 events10 affected58 at risk EG003
Oedema	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected59 at risk EG0012 events2 affected62 at risk EG0027 events6 affected58 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0013 events2 affected62 at risk EG0026 events4 affected58 at risk EG003
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG00022 events17 affected59 at risk EG00127 events16 affected62 at risk EG00232 events23 affected58 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0012 events1 affected62 at risk EG0020 events0 affected58 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0005 events4 affected59 at risk EG0012 events2 affected62 at risk EG0020 events0 affected58 at risk EG003
Cystitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0023 events3 affected58 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG00018 events11 affected59 at risk EG00128 events14 affected62 at risk EG00246 events17 affected58 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG00010 events8 affected59 at risk EG00113 events12 affected62 at risk EG00225 events12 affected58 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0005 events3 affected59 at risk EG0011 events1 affected62 at risk EG0024 events3 affected58 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected59 at risk EG0010 events0 affected62 at risk EG0020 events0 affected58 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0014 events4 affected62 at risk EG0024 events3 affected58 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0006 events3 affected59 at risk EG0012 events2 affected62 at risk EG0023 events3 affected58 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0008 events3 affected59 at risk EG0017 events3 affected62 at risk EG0022 events2 affected58 at risk EG003
Platelet count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0013 events3 affected62 at risk EG0029 events5 affected58 at risk EG003
White blood cell count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG00015 events4 affected59 at risk EG00116 events5 affected62 at risk EG0022 events1 affected58 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected62 at risk EG0025 events5 affected58 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected59 at risk EG0012 events2 affected62 at risk EG0021 events1 affected58 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0016 events6 affected62 at risk EG0022 events2 affected58 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0012 events2 affected62 at risk EG0024 events3 affected58 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG00013 events10 affected59 at risk EG00116 events11 affected62 at risk EG00213 events9 affected58 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG00011 events8 affected59 at risk EG00117 events13 affected62 at risk EG0029 events4 affected58 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected59 at risk EG0017 events6 affected62 at risk EG0023 events3 affected58 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0003 events2 affected59 at risk EG0017 events6 affected62 at risk EG0023 events3 affected58 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG00110 events8 affected62 at risk EG0028 events7 affected58 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected59 at risk EG0015 events4 affected62 at risk EG0020 events0 affected58 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0005 events4 affected59 at risk EG00113 events13 affected62 at risk EG00211 events8 affected58 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0003 events2 affected59 at risk EG00111 events8 affected62 at risk EG0020 events0 affected58 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected59 at risk EG0012 events2 affected62 at risk EG0021 events1 affected58 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0005 events4 affected59 at risk EG0015 events4 affected62 at risk EG0026 events4 affected58 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected59 at risk EG0014 events4 affected62 at risk EG0026 events3 affected58 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0012 events2 affected62 at risk EG0027 events4 affected58 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00022 events22 affected59 at risk EG00118 events18 affected62 at risk EG00215 events14 affected58 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0016 events4 affected62 at risk EG0025 events3 affected58 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected59 at risk EG0011 events1 affected62 at risk EG0025 events5 affected58 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0003 events3 affected59 at risk EG0016 events6 affected62 at risk EG0021 events1 affected58 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0007 events6 affected59 at risk EG0016 events5 affected62 at risk EG0023 events3 affected58 at risk EG003
Phlebitis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0003 events2 affected59 at risk EG0011 events1 affected62 at risk EG0023 events3 affected58 at risk EG003

ID	Term
D001943	Breast Neoplasms

ID	Term
D000093542	Gemcitabine
D000077143	Docetaxel
D017239	Paclitaxel

Ancestor Terms

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

Arm A, Docetaxel and Gemcitabine (3 Weekly):

Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Arm B, Paclitaxel and Gemcitabine (3 Weekly):

Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

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