A Study to Evaluate the Effect of the Combination of Pert... | NCT02004093

NCT02004093

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

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
Chemotherapy + Pertuzumab	Experimental		Drug: pertuzumab Drug: paclitaxel Drug: gemcitabine Drug: carboplatin
Chemotherapy	Active Comparator		Drug: paclitaxel Drug: gemcitabine Drug: carboplatin

Name	Type	Description	Arm Group Labels	Other Names
pertuzumab	Drug	Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks	Chemotherapy + Pertuzumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Disease Progression or Death	Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.	Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Progression-Free Survival	Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.	Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Kaplan-Meier Probability of No Disease or Progression at 1 Year	The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements	Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were "response", "stable disease" and "progressive disease". Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

References Module

No data available

No data is available for this block.

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	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 milligrams (mg) intravenously (IV) on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/square meters (m^2) IV on Day 1 and carboplatin target area under the curve (AUC) 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

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

FG00075 subjectsIncludes 1 participant who was randomized to chemotherapy group but received pertuzumab+chemotherapy

All participants who received randomized treatment (All Treated Population, for Efficacy Analyses); 1 participant was randomized to the chemotherapy arm but received pertuzumab+chemotherapy and is thus included in this arm for all analyses.

Arm/Group Information

ID	Title	Description
BG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
BG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
BG002	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
	OG00087.8 OG00180.0

Primary

Progression-Free Survival

Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.

All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.

Posted

Median

Full Range

weeks

Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Secondary

Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements

Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were "response", "stable disease" and "progressive disease". Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".

All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.

Posted

Number

percentage of participants

Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Secondary

Duration of Response

For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.

Only participants with a response were included in the analysis; 8 participants and 13 participants were censored in the chemotherapy + pertuzumab and chemotherapy only treatment groups, respectively.

Posted

Median

Inter-Quartile Range

weeks

Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Secondary

Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year

All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 7 and 5 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.

Posted

Number

percent

1 year

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Units	Counts

Secondary

Percentage of Participants With Disease Progression

Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.

All treated participants were included in analysis

Posted

Number

percentage of participants

Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Secondary

Time to Progressive Disease

The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.

All treated patients with an event (disease progression) were included in analysis

Posted

Median

Inter-Quartile Range

weeks

Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Secondary

Kaplan-Meier Probability of Being Progression Free at 1 Year

All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 16 and 10 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.

Posted

Number

percent

1 year

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Units	Counts

Primary

Kaplan-Meier Probability of No Disease or Progression at 1 Year

The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.

All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 17 and 12 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.

Posted

Number

percent

1 year

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Secondary

Time To Response

Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.

Only participants with a response were included in the analysis.

Posted

Median

Inter-Quartile Range

weeks

Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen17 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Secondary

Percentage of Participants Who Died

All treated participants were included in analysis

Posted

Number

percentage of participants

Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Units	Counts
Participants

Secondary

Overall Survival

Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.

All treated participants were included in analysis

Posted

Median

Full Range

months

Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Secondary

Kaplan-Meier Probability of Being Alive at 1 Year

All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.

Posted

Number

percent

1 year

ID	Title	Description
OG000	Chemotherapy + Pertuzumab	Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles. Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
OG001	Chemotherapy	Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Chemotherapy + Pertuzumab	Participants received loading dose of 840mg IV Pertuzumab, followed by 420 mg IV every 3 weeks (for a total of 17 cycles), along with chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles, followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.			20	75	72	75
EG001	Chemotherapy	Participants received chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/ m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.			12	74	68	74

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected75 at risk EG0011 affected74 at risk
Ascites	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0011 affected74 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected75 at risk EG0010 affected74 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected75 at risk EG0010 affected74 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected75 at risk EG0010 affected74 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected74 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Large intesting perforation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected74 at risk
Appendicitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected74 at risk
Cystitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected74 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected75 at risk EG0013 affected74 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected74 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected75 at risk EG0010 affected74 at risk
Local swelling	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Obstruction	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected74 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected75 at risk EG0010 affected74 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0011 affected74 at risk
Diaphragmatic hernia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Syncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Blood glucose increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0010 affected74 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected75 at risk EG0011 affected74 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00044 affected75 at risk EG00133 affected74 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00044 affected75 at risk EG00114 affected74 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00024 affected75 at risk EG00122 affected74 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00020 affected75 at risk EG00122 affected74 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00018 affected75 at risk EG00114 affected74 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0009 affected75 at risk EG0016 affected74 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00010 affected75 at risk EG0013 affected74 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0012 affected74 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA13.1	Systematic Assessment	EG0006 affected75 at risk EG0011 affected74 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected75 at risk EG0014 affected74 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected75 at risk EG0010 affected74 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00036 affected75 at risk EG00143 affected74 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00019 affected75 at risk EG00121 affected74 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00011 affected75 at risk EG00118 affected74 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0009 affected75 at risk EG00112 affected74 at risk
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG00030 affected75 at risk EG00127 affected74 at risk
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG0009 affected75 at risk EG00110 affected74 at risk
Oedema peripheral	General disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected75 at risk EG0016 affected74 at risk
Mucosal inflammation	General disorders	MedDRA 13.1	Systematic Assessment	EG0007 affected75 at risk EG0011 affected74 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0013 affected74 at risk
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0011 affected74 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00022 affected75 at risk EG00125 affected74 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00017 affected75 at risk EG0017 affected74 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0007 affected75 at risk EG0019 affected74 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0008 affected75 at risk EG0010 affected74 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0012 affected74 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected75 at risk EG0011 affected74 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00016 affected75 at risk EG0018 affected74 at risk
Dizziness	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0009 affected75 at risk EG0016 affected74 at risk
Dysgeusia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00010 affected75 at risk EG0015 affected74 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00011 affected75 at risk EG0014 affected74 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0008 affected75 at risk EG0014 affected74 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected75 at risk EG0014 affected74 at risk
Lethargy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected75 at risk EG0012 affected74 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG00011 affected75 at risk EG0014 affected74 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0017 affected74 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0016 affected74 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected75 at risk EG0015 affected74 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected75 at risk EG0013 affected74 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0007 affected75 at risk EG0011 affected74 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0012 affected74 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00014 affected75 at risk EG0013 affected74 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0008 affected75 at risk EG0015 affected74 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0014 affected74 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG00011 affected75 at risk EG00113 affected74 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG00019 affected75 at risk EG0014 affected74 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0006 affected75 at risk EG0012 affected74 at risk
Cystitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0007 affected75 at risk EG0010 affected74 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0012 affected74 at risk
Phlebitis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected75 at risk EG0015 affected74 at risk
Flushing	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected75 at risk EG0012 affected74 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected75 at risk EG0010 affected74 at risk
Insomnia	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected75 at risk EG0015 affected74 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected75 at risk EG0010 affected74 at risk

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders

ID	Term
C485206	pertuzumab
D017239	Paclitaxel
D000093542	Gemcitabine
D016190	Carboplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D056831	Coordination Complexes

Units	Counts
Participants	OG00074 OG00175

Units	Counts
Participants	OG00074 OG00175

Facility	Status	City	State	ZIP	Country	Contacts
		Brussels		1000	Belgium