An Efficacy and Safety Study of MORAb-003 in Platinum-Res... | NCT00738699

Label	Type	Description	Intervention Names
1	Active Comparator	MORAb-003 (Farletuzumab) Plus Paclitaxel	Drug: MORAb-003 (farletuzumab) Drug: Paclitaxel
2	Placebo Comparator	Placebo Plus Paclitaxel	Drug: 0.9% Saline Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
MORAb-003 (farletuzumab)	Drug	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).	Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Overall Survival (OS)	OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.	Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

Measure	Description	Time Frame
Best Overall Response	BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).

Measure	Description	Time Frame
Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)	Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.	Length of study
Serologic Response Rate

Facility	Status	City	State	ZIP	Country	Contacts
Southern Cancer Center		Mobile	Alabama	36608	United States
St. Joseph's Hospital and Medical Center

ID	Title	Description
FG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.

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

Progression-Free Survival (PFS)

PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).

Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment.

Posted

Median

95% Confidence Interval

Months

Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

ID	Title	Description
OG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
OG001	Placebo (Normal Saline) Plus Paclitaxel	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.

Units	Counts
Participants	OG000275 OG001140

Title

Denominators

Categories

Title	Measurements
	OG0003.5(3.3 to 3.9) OG0013.7(3.3 to 5.2)

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		0.8360	One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).	Cox Proportional Hazard	1.13			2-Sided	95	0.88	1.46			Stratified as described above.		Superiority or Other

Primary

Overall Survival (OS)

OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.

ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.

Posted

Median

95% Confidence Interval

Months

Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

ID	Title	Description
OG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
OG001	Placebo (Normal Saline) Plus Paclitaxel	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.

Secondary

Best Overall Response

BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).

ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.

Posted

Number

Percentage of participants

Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

ID	Title	Description
OG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.

Secondary

Time to Tumor Response (TTR)

TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.

ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.

Posted

Median

95% Confidence Interval

Months

Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months

ID	Title	Description
OG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
OG001	Placebo (Normal Saline) Plus Paclitaxel

Other Pre-specified

Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)

Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.

Posted

Length of study

ID	Title	Description
OG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
OG001	Placebo (Normal Saline) Plus Paclitaxel	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.

Other Pre-specified

Serologic Response Rate

Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.

Posted

Length of study

ID	Title	Description
OG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
OG001	Placebo (Normal Saline) Plus Paclitaxel	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDra 14.1	Non-systematic Assessment	EG0007 affected279 at risk EG0017 affected133 at risk
Neutropenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0006 affected279 at risk EG0011 affected133 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0004 affected279 at risk EG0011 affected133 at risk
Leukopenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0010 affected133 at risk
Atrial Fibrillation	Cardiac disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0011 affected133 at risk
Cardiac Failure Congestive	Cardiac disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Cardio-Respiratory Arrest	Cardiac disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	Select	Systematic Assessment	EG00018 affected279 at risk EG0017 affected133 at risk
Intestinal Obstruction	Gastrointestinal disorders	Select	Systematic Assessment	EG00010 affected279 at risk EG0014 affected133 at risk
Vomiting	Gastrointestinal disorders	Select	Systematic Assessment	EG0009 affected279 at risk EG0015 affected133 at risk
Constipation	Gastrointestinal disorders	Select	Systematic Assessment	EG0009 affected279 at risk EG0012 affected133 at risk
Ascites	Gastrointestinal disorders	Select	Systematic Assessment	EG0008 affected279 at risk EG0012 affected133 at risk
Nausea	Gastrointestinal disorders	Select	Systematic Assessment	EG0005 affected279 at risk EG0013 affected133 at risk
Abdominal Pain	Gastrointestinal disorders	Select	Systematic Assessment	EG0005 affected279 at risk EG0011 affected133 at risk
Diarrhoea	Gastrointestinal disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0013 affected133 at risk
Colonic Obstruction	Gastrointestinal disorders	Select	Systematic Assessment	EG0003 affected279 at risk EG0010 affected133 at risk
Ileus	Gastrointestinal disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0011 affected133 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0010 affected133 at risk
Gastrointestinal Obstruction	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Intestinal Perforation	Gastrointestinal disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0010 affected133 at risk
Large Intestinal Obstruction	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Large Intestine Perforation	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Abdominal adhesions	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Colonic Pseudo-obstruction	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Diverticulum	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Enterocutaneous Fistula	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Faecal Volume Decreased	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Faecal Volume Increased	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Gastric Ulcer	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Gastrointestinal Inflammation	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Gastrointestinal Perforation	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Oesophageal Obstruction	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Rectourethral Fistula	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Short-Bowel Syndrome	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Disease Progression	General disorders	Select	Systematic Assessment	EG00017 affected279 at risk EG0017 affected133 at risk
Pyrexia	General disorders	Select	Systematic Assessment	EG00015 affected279 at risk EG0012 affected133 at risk
Fatigue	General disorders	Select	Systematic Assessment	EG0003 affected279 at risk EG0011 affected133 at risk
Asthenia	General disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Obstruction	General disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Pain	General disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Generalised Oedema	General disorders	MedDra 14.1	Non-systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Hernia Obstructive	General disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Oedema Peripheral	General disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDra 14.1	Non-systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Cholangitis	Hepatobiliary disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Cellulitis	Infections and infestations	MedDra 14.1	Non-systematic Assessment	EG0006 affected279 at risk EG0012 affected133 at risk
Urinary Tract Infection	Infections and infestations	Select	Systematic Assessment	EG0005 affected279 at risk EG0013 affected133 at risk
Pneumonia	Infections and infestations	Select	Systematic Assessment	EG0004 affected279 at risk EG0012 affected133 at risk
Sepsis	Infections and infestations	Select	Systematic Assessment	EG0003 affected279 at risk EG0011 affected133 at risk
Catheter Site Infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Device Related Infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Lobar Pneumonia	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Abdominal Infection	Infections and infestations	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Bacterial Pyelonephritis	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Candida Sepsis	Infections and infestations	MedDra 14.1	Non-systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Clostridium Difficle Colitis	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Escherichia Sepsis	Infections and infestations	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Herpes Zoster	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Incision Site Infection	Infections and infestations	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Infectious Peritonitis	Infections and infestations	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Klebsiella Bacteraemia	Infections and infestations	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Meningitis	Infections and infestations	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Parotitis	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Pelvic Infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Postoperative Wound Infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Pseudomonal Sepsis	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Respiratory Tract Infection	Infections and infestations	MedDra 14.1	Non-systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Retroperitoneal Abcess	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Urosepsis	Infections and infestations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Postoperative Ileus	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Tibia fracture	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Haemoglobin Decreased	Investigations	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Weight decreased	Investigations	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Dehydration	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0004 affected279 at risk EG0010 affected133 at risk
Decreased Appetite	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Failure to thrive	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Hypocalcaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Hypokalaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDra 14.1	Non-systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Hyponatraemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Hypophagia	Metabolism and nutrition disorders	MedDra 14.1	Non-systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Malnutrition	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Back Pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0011 affected133 at risk
Fistula	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Muscle Necrosis	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Systemic Lupus Erythematosus	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Oncologic Complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDra 14.1	Non-systematic Assessment	EG0003 affected279 at risk EG0010 affected133 at risk
Metastases to Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Select	Systematic Assessment	EG0000 affected279 at risk EG0012 affected133 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Metastatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Tumour Associated Fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Syncope	Nervous system disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0011 affected133 at risk
Brain Mass	Nervous system disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Convulsion	Nervous system disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Encephelopathy	Nervous system disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Lethargy	Nervous system disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Mononeuritis	Nervous system disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Neuropathy Peripheral	Nervous system disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Posterior Reversible Encephelopathy Syndrome	Nervous system disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Depression	Psychiatric disorders	MedDra 14.1	Non-systematic Assessment	EG0002 affected279 at risk EG0011 affected133 at risk
Anxiety	Psychiatric disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Disorientation	Psychiatric disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Mental Status Change	Psychiatric disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Renal Failure Acute	Renal and urinary disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0012 affected133 at risk
Hydronephrosis	Renal and urinary disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0011 affected133 at risk
Renal Failure	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0012 affected133 at risk
Bladder Spasm	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Dysuria	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Renal Impairment	Renal and urinary disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Ureteric Obstruction	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Urinary Tract Obstruction	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDra 14.1	Non-systematic Assessment	EG00010 affected279 at risk EG0014 affected133 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0007 affected279 at risk EG0014 affected133 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0003 affected279 at risk EG0012 affected133 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDra 14.1	Non-systematic Assessment	EG0005 affected279 at risk EG0010 affected133 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Dermatits Exfoliative	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Rash	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Skin Toxicity	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Hypotension	Vascular disorders	Select	Systematic Assessment	EG0002 affected279 at risk EG0012 affected133 at risk
Thrombosis	Vascular disorders	Select	Systematic Assessment	EG0003 affected279 at risk EG0010 affected133 at risk
Deep Vein Thrombosis	Vascular disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0011 affected133 at risk
Subclavian Vein Thrombosis	Vascular disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Superior Vena Cava Syndrome	Vascular disorders	Select	Systematic Assessment	EG0000 affected279 at risk EG0011 affected133 at risk
Venous Thrombosis Limb	Vascular disorders	Select	Systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk
Pneumonia bacterial	Infections and infestations	MedDra 14.1	Non-systematic Assessment	EG0001 affected279 at risk EG0010 affected133 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDra 14.1	Non-systematic Assessment	EG000132 affected279 at risk EG00166 affected133 at risk
Diarrhoea	Gastrointestinal disorders	Select	Systematic Assessment	EG000119 affected279 at risk EG00153 affected133 at risk
Constipation	Gastrointestinal disorders	Select	Systematic Assessment	EG00096 affected279 at risk EG00153 affected133 at risk
Abdominal pain	Gastrointestinal disorders	Select	Systematic Assessment	EG00088 affected279 at risk EG00134 affected133 at risk
Vomiting	Gastrointestinal disorders	Select	Systematic Assessment	EG00084 affected279 at risk EG00137 affected133 at risk
Abdominal Distension	Gastrointestinal disorders	Select	Systematic Assessment	EG00051 affected279 at risk EG00121 affected133 at risk
Ascites	Gastrointestinal disorders	Select	Systematic Assessment	EG00022 affected279 at risk EG00111 affected133 at risk
Stomatitis	Gastrointestinal disorders	Select	Systematic Assessment	EG00026 affected279 at risk EG0017 affected133 at risk
Dyspepsia	Gastrointestinal disorders	Select	Systematic Assessment	EG00022 affected279 at risk EG00110 affected133 at risk
Abdominal Pain Upper	Gastrointestinal disorders	Select	Systematic Assessment	EG00025 affected279 at risk EG0016 affected133 at risk
Dry mouth	Gastrointestinal disorders	Select	Systematic Assessment	EG00019 affected279 at risk EG0018 affected133 at risk
Small intestinal Obstruction	Gastrointestinal disorders	Select	Systematic Assessment	EG00019 affected279 at risk EG0017 affected133 at risk
Flatulence	Gastrointestinal disorders	Select	Systematic Assessment	EG00018 affected279 at risk EG0015 affected133 at risk
Gastroresophageal Reflux Disease	Gastrointestinal disorders	Select	Systematic Assessment	EG00010 affected279 at risk EG0018 affected133 at risk
Fatigue	General disorders	Select	Systematic Assessment	EG000184 affected279 at risk EG00182 affected133 at risk
Oedema Peripheral	General disorders	Select	Systematic Assessment	EG00060 affected279 at risk EG00126 affected133 at risk
Pyrexia	General disorders	Select	Systematic Assessment	EG00043 affected279 at risk EG00118 affected133 at risk
Asthenia	General disorders	Select	Systematic Assessment	EG00024 affected279 at risk EG00112 affected133 at risk
Mucosal Inflammation	General disorders	Select	Systematic Assessment	EG00024 affected279 at risk EG00111 affected133 at risk
Chills	General disorders	Select	Systematic Assessment	EG00018 affected279 at risk EG0017 affected133 at risk
Disease Progression	General disorders	Select	Systematic Assessment	EG00017 affected279 at risk EG0017 affected133 at risk
Pain	General disorders	Select	Systematic Assessment	EG00017 affected279 at risk EG0017 affected133 at risk
Oedema	General disorders	Select	Systematic Assessment	EG0006 affected279 at risk EG0017 affected133 at risk
Neuropathy Peripheral	Nervous system disorders	MedDra 14.1	Non-systematic Assessment	EG00075 affected279 at risk EG00137 affected133 at risk
Headache	Nervous system disorders	Select	Systematic Assessment	EG00072 affected279 at risk EG00128 affected133 at risk
Dizziness	Nervous system disorders	Select	Systematic Assessment	EG00042 affected279 at risk EG00118 affected133 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	Select	Systematic Assessment	EG00038 affected279 at risk EG00115 affected133 at risk
Dysguesia	Nervous system disorders	Select	Systematic Assessment	EG00029 affected279 at risk EG00122 affected133 at risk
Restless Legs Syndrome	Nervous system disorders	Select	Systematic Assessment	EG00014 affected279 at risk EG0012 affected133 at risk
Hypoaesthesia	Nervous system disorders	Select	Systematic Assessment	EG0006 affected279 at risk EG0017 affected133 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDra 14.1	Non-systematic Assessment	EG00058 affected279 at risk EG00127 affected133 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG00056 affected279 at risk EG00121 affected133 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG00050 affected279 at risk EG00125 affected133 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG00029 affected279 at risk EG0016 affected133 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG00016 affected279 at risk EG00113 affected133 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0009 affected279 at risk EG0019 affected133 at risk
Urinary Tract Infection	Infections and infestations	Select	Systematic Assessment	EG00047 affected279 at risk EG00130 affected133 at risk
Upper Respiratory Tract Infection	Infections and infestations	Select	Systematic Assessment	EG00024 affected279 at risk EG0016 affected133 at risk
Nasopharyngitits	Infections and infestations	Select	Systematic Assessment	EG00016 affected279 at risk EG0014 affected133 at risk
Sinusitis	Infections and infestations	Select	Systematic Assessment	EG00010 affected279 at risk EG0019 affected133 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDra 14.1	Non-systematic Assessment	EG00043 affected279 at risk EG00122 affected133 at risk
Back Pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG00036 affected279 at risk EG00126 affected133 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG00028 affected279 at risk EG00117 affected133 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG00031 affected279 at risk EG00112 affected133 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG00014 affected279 at risk EG00112 affected133 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG00015 affected279 at risk EG0016 affected133 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG00014 affected279 at risk EG0016 affected133 at risk
Decreased Appetite	Metabolism and nutrition disorders	Select	Systematic Assessment	EG00067 affected279 at risk EG00127 affected133 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG00031 affected279 at risk EG00118 affected133 at risk
Hypokalaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG00028 affected279 at risk EG0019 affected133 at risk
Dehydration	Metabolism and nutrition disorders	Select	Systematic Assessment	EG00014 affected279 at risk EG0015 affected133 at risk
Anaemia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG00078 affected279 at risk EG00137 affected133 at risk
Neutropenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG00038 affected279 at risk EG00118 affected133 at risk
Leukopenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG00016 affected279 at risk EG0019 affected133 at risk
Insomnia	Psychiatric disorders	Select	Systematic Assessment	EG00054 affected279 at risk EG00123 affected133 at risk
Anxiety	Psychiatric disorders	Select	Systematic Assessment	EG00025 affected279 at risk EG00116 affected133 at risk
Depression	Psychiatric disorders	Select	Systematic Assessment	EG00024 affected279 at risk EG0018 affected133 at risk
Flushing	Vascular disorders	Select	Systematic Assessment	EG00028 affected279 at risk EG0019 affected133 at risk
Hypotension	Vascular disorders	Select	Systematic Assessment	EG00010 affected279 at risk EG0017 affected133 at risk
Dysuria	Renal and urinary disorders	Select	Systematic Assessment	EG0009 affected279 at risk EG00112 affected133 at risk
Pollakiuria	Renal and urinary disorders	Select	Systematic Assessment	EG0007 affected279 at risk EG0019 affected133 at risk
Contusion	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG00019 affected279 at risk EG0011 affected133 at risk
Vision Blurred	Eye disorders	Select	Systematic Assessment	EG00014 affected279 at risk EG0018 affected133 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDra 14.1	Non-systematic Assessment	EG000143 affected279 at risk EG00159 affected133 at risk
Rash	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG00055 affected279 at risk EG00119 affected133 at risk
Nail disorder	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG00047 affected279 at risk EG00119 affected133 at risk
Dry skin	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG00018 affected279 at risk EG0017 affected133 at risk
Erythema	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG00018 affected279 at risk EG0016 affected133 at risk
Pruritus	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG00015 affected279 at risk EG0018 affected133 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG00013 affected279 at risk EG0017 affected133 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG00011 affected279 at risk EG0017 affected133 at risk

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
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
BG001	Placebo (Normal Saline) Plus Paclitaxel	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MORAb-003 (Farletuzumab) Plus Paclitaxel	Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.			127	279	278	279
EG001	Placebo (Normal Saline) Plus Paclitaxel	An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.			55	133	133	133

ID	Term
C527484	farletuzumab
D000077330	Saline Solution
D017239	Paclitaxel