Trial Outcomes & Findings for Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse (NCT NCT00849667)

NCT ID: NCT00849667

Last Updated: 2022-12-30

Results Overview

PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors \[RECIST\]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, 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).

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1100 participants
• Primary outcome timeframe: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
• Results posted on: 2022-12-30

Participant Flow

Participants took part in the study at 274 investigative sites in North America, Europe, Asia Pacific, Latin America, and Japan from 16 April 2009 to 12 April 2013.

A total of 1100 participants were randomized and enrolled, out of which 1091 participants received study treatment. Study was terminated early due to lack of efficacy based on the results for progression-free survival (PFS).

Participant milestones

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin Participants received farletuzumab 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion, weekly followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve area under curve (AUC) 5 or 6 milligram per minute per milliliter (mg/min/mL) (carboplatin dose \[milligram {mg}\] = Target AUC \[mg\*min/mL\]\*glomerular filtration rate \[GFR\] milliliter per minute \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin Participants received farletuzumab-matched placebo (0.9 percent \[%\] saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Overall Study STARTED	370	366	364
Overall Study Safety Analysis Set	376	363	352
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	370	366	364

Reasons for withdrawal

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin Participants received farletuzumab 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion, weekly followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve area under curve (AUC) 5 or 6 milligram per minute per milliliter (mg/min/mL) (carboplatin dose \[milligram {mg}\] = Target AUC \[mg\*min/mL\]\*glomerular filtration rate \[GFR\] milliliter per minute \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin Participants received farletuzumab-matched placebo (0.9 percent \[%\] saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Overall Study Withdrawal by Subject	16	33	35
Overall Study Lost to Follow-up	8	8	8
Overall Study Adverse Event	1	2	0
Overall Study Other	18	19	18
Overall Study Progressive disease	119	100	112
Overall Study Sponsor decision	208	204	190
Overall Study Investigator discretion	0	0	1

Baseline Characteristics

Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

Baseline characteristics by cohort

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=370 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=366 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=364 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Total n=1100 Participants Total of all reporting groups
Age, Continuous	58.3 Years STANDARD_DEVIATION 10.35 • n=93 Participants	58.3 Years STANDARD_DEVIATION 10.26 • n=4 Participants	59.0 Years STANDARD_DEVIATION 10.22 • n=27 Participants	58.6 Years STANDARD_DEVIATION 10.27 • n=483 Participants
Sex: Female, Male Female	370 Participants n=93 Participants	366 Participants n=4 Participants	364 Participants n=27 Participants	1100 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=93 Participants	38 Participants n=4 Participants	25 Participants n=27 Participants	97 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	331 Participants n=93 Participants	321 Participants n=4 Participants	331 Participants n=27 Participants	983 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	7 Participants n=4 Participants	8 Participants n=27 Participants	20 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) Asian	85 Participants n=93 Participants	76 Participants n=4 Participants	86 Participants n=27 Participants	247 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	10 Participants n=4 Participants	1 Participants n=27 Participants	16 Participants n=483 Participants
Race (NIH/OMB) White	272 Participants n=93 Participants	271 Participants n=4 Participants	268 Participants n=27 Participants	811 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	7 Participants n=4 Participants	7 Participants n=27 Participants	19 Participants n=483 Participants

PRIMARY outcome

Timeframe: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

Population: ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.

PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors [RECIST]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, 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).

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=370 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=366 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=364 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Progression-free Survival (PFS)	9.5 months Interval 8.6 to 10.2	9.7 months Interval 8.8 to 10.4	9.0 months Interval 8.4 to 9.8

SECONDARY outcome

Timeframe: From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)

Population: ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.

OS was defined as the time (in months) from the date of randomization to the date of death, due to any 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.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=370 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=366 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=364 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Overall Survival (OS)	28.7 months Interval 26.6 to 33.5	32.1 months Interval 26.7 to 35.0	29.1 months Interval 25.6 to 30.7

SECONDARY outcome

Timeframe: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

Population: ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.

CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (>=) 2 multiple (*) ULN with either event documented on two occasions or CA-125 >=2*nadir value with either event documented on two occasions.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=370 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=366 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=364 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Cancer Antigen-125 (CA-125) Progression-Free Survival	13.2 months Interval 11.8 to 14.4	18.1 months Interval 12.7 to Here NA signifies that the upper limit of confidence interval (CI) was not estimable due to insufficient number of events.	12.0 months Interval 11.1 to 14.6

SECONDARY outcome

Timeframe: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

Population: ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.

PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 >=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 >=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 >=two times ULN on two occasions at least one week apart.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=370 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=366 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=364 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria	8.8 months Interval 8.4 to 9.7	8.6 months Interval 8.3 to 9.5	8.4 months Interval 8.2 to 9.0

SECONDARY outcome

Timeframe: From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)

Population: ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. Here "N" overall number of participants analyzed included all participants with potential for second remission greater than first remission.

Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=198 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=200 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=201 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Percentage of Participants With Length of Second Remission Greater Than First Remission	4.0 percentage of participants Interval 1.8 to 7.8	6.5 percentage of participants Interval 3.5 to 10.9	4.5 percentage of participants Interval 2.1 to 8.3

SECONDARY outcome

Timeframe: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)

Population: ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.

Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=370 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=366 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=364 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Percentage of Participants With Objective Response	57.6 percentage of participants Interval 52.4 to 62.7	58.2 percentage of participants Interval 53.0 to 63.3	55.8 percentage of participants Interval 50.5 to 60.9

SECONDARY outcome

Timeframe: From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)

Population: Analysis performed on a subset of participants who had objective response.

Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=211 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=211 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=200 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Duration of Tumor Response	8.0 months Interval 7.6 to 9.2	8.9 months Interval 7.7 to 9.7	7.6 months Interval 7.1 to 8.7

SECONDARY outcome

Timeframe: From the date of randomization to first documentation of objective response (up to 48 months)

Population: Analysis performed on a subset of participants who had objective response.

Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=211 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=211 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=200 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Time to Tumor Response (TTR)	1.5 months Interval 1.4 to 1.7	1.5 months Interval 1.4 to 1.7	1.5 months Interval 1.4 to 1.9

SECONDARY outcome

Timeframe: Up to 48 months

Population: SR Evaluable Populations included all randomized participants who received at least one dose of study drug and who had a baseline and at least one assessment during treatment, sufficient to assess the endpoint of interest.

SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=273 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=273 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=272 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Percentage of Participants With Serologic Response (SR) 50% SR (Responder)	91.9 percentage of participants Interval 88.1 to 94.9	97.4 percentage of participants Interval 94.8 to 99.0	92.3 percentage of participants Interval 88.4 to 95.2
Percentage of Participants With Serologic Response (SR) 75% SR (Responder)	86.1 percentage of participants Interval 81.4 to 90.0	85.7 percentage of participants Interval 81.0 to 89.6	82.0 percentage of participants Interval 76.9 to 86.4
Percentage of Participants With Serologic Response (SR) SR leading to normalization (Responder)	65.2 percentage of participants Interval 59.2 to 70.8	64.8 percentage of participants Interval 58.9 to 70.5	59.9 percentage of participants Interval 53.8 to 65.8

SECONDARY outcome

Timeframe: From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)

Population: Analysis was performed on a subset of participants who had serologic response.

Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=251 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=266 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=251 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Duration of 50% Serologic Response	10.7 months Interval 9.7 to 12.0	12.0 months Interval 10.4 to 16.7	9.9 months Interval 9.0 to 11.5

SECONDARY outcome

Timeframe: From the date of randomization to first documentation of 50% SR (up to 48 months)

Population: Analysis was performed on a subset of participants who had serologic response.

TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=251 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=266 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=251 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Time to 50% Serologic Response (TSR)	1.0 months Interval 0.9 to 1.0	0.9 months Interval 0.9 to 1.0	1.2 months Interval 1.0 to 1.4

SECONDARY outcome

Timeframe: Up to 48 months

Population: ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.

Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=370 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=366 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=364 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Percentage of Participants With Clinical Benefit	68.9 percentage of participants	66.4 percentage of participants	64.6 percentage of participants

SECONDARY outcome

Timeframe: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

Population: Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=1 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=2 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=4 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel Total Carboplatin	19.30 microgram per milliliter (mcg/mL) Standard Deviation NA Here NA signifies that standard deviation could not be determined because only one participant was analyzed.	43.55 microgram per milliliter (mcg/mL) Standard Deviation 22.84	21.72 microgram per milliliter (mcg/mL) Standard Deviation 12.08
Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel Total Paclitaxel	3.29 microgram per milliliter (mcg/mL) Standard Deviation NA Here NA signifies that standard deviation could not be determined because only one participant was analyzed.	3.86 microgram per milliliter (mcg/mL) Standard Deviation 0.20	4.95 microgram per milliliter (mcg/mL) Standard Deviation 2.73

SECONDARY outcome

Timeframe: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

Population: Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=1 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=2 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=4 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel Total Carboplatin	0.75 hours Interval 0.75 to 0.75	0.79 hours Interval 0.5 to 1.08	1.96 hours Interval 0.75 to 3.83
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel Total Paclitaxel	3.00 hours Interval 3.0 to 3.0	3.21 hours Interval 3.0 to 3.42	3.00 hours Interval 2.0 to 3.17

SECONDARY outcome

Timeframe: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

Population: Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=1 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=2 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=3 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel Total Carboplatin	58.70 microgram hour per liter (mcg*h/L) Standard Deviation NA Here NA signifies that standard deviation could not be determined because only one participant was analyzed.	77.05 microgram hour per liter (mcg*h/L) Standard Deviation 8.41	70.37 microgram hour per liter (mcg*h/L) Standard Deviation 10.40
AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel Total Paclitaxel	—	12.30 microgram hour per liter (mcg*h/L) Standard Deviation 1.27	16.19 microgram hour per liter (mcg*h/L) Standard Deviation 6.41

SECONDARY outcome

Timeframe: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

Population: Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=1 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=2 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=4 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel Total Carboplatin	2.94 hours Standard Deviation NA Here NA signifies that standard deviation could not be determined because only one participant was analyzed.	1.64 hours Standard Deviation 0.31	1.72 hours Standard Deviation 0.65
T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel Total Paclitaxel	1.55 hours Standard Deviation NA Here NA signifies that standard deviation could not be determined because only one participant was analyzed.	4.82 hours Standard Deviation 2.88	4.78 hours Standard Deviation 3.24

SECONDARY outcome

Timeframe: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

Population: Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=1 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=2 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=3 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
CL: Clearance of Total Carboplatin and Total Paclitaxel Total Paclitaxel	—	24.80 liter per hour (L/h) Standard Deviation 1.27	21.00 liter per hour (L/h) Standard Deviation 11.08
CL: Clearance of Total Carboplatin and Total Paclitaxel Total Carboplatin	6.65 liter per hour (L/h) Standard Deviation NA Here NA signifies that standard deviation could not be determined because only one participant was analyzed.	8.77 liter per hour (L/h) Standard Deviation 2.02	7.21 liter per hour (L/h) Standard Deviation 2.40

SECONDARY outcome

Timeframe: Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)

Population: Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=1 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=2 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=3 Participants Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel Total Carboplatin	28.20 liter Standard Deviation NA Here NA signifies that standard deviation could not be determined because only one participant was analyzed.	20.30 liter Standard Deviation 0.85	14.86 liter Standard Deviation 5.51
Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel Total Paclitaxel	—	169.50 liter Standard Deviation 94.05	110.23 liter Standard Deviation 52.34

SECONDARY outcome

Timeframe: Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days)

Population: The population comprised of all evaluable participants who received at least one dose of farletuzumab or placebo, with study treatment assignment designated according to the IWRS/IVRS, and who completed a baseline FACT-O assessment and at least one follow-up FACT-O assessment during the study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure.

Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.

Outcome measures

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=644 Participants Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=300 Participants Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores Cycle 3	69.6 score on a scale Standard Deviation 1.0	70.7 score on a scale Standard Deviation 1.1	—
Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores Cycle 6	70.1 score on a scale Standard Deviation 1.0	70.7 score on a scale Standard Deviation 1.1	—
Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores Cycle 12	76.2 score on a scale Standard Deviation 1.7	72.9 score on a scale Standard Deviation 2.4	—

Adverse Events

1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin

Serious events: 140 serious events

Other events: 373 other events

Deaths: 143 deaths

2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin

Serious events: 130 serious events

Other events: 358 other events

Deaths: 119 deaths

Placebo Plus Taxane and Carboplatin

Serious events: 112 serious events

Other events: 347 other events

Deaths: 121 deaths

Serious adverse events

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=376 participants at risk Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=363 participants at risk Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=352 participants at risk Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Blood and lymphatic system disorders Neutropenia	9.3% 35/376 • Number of events 43 • Up to 48 months	6.1% 22/363 • Number of events 42 • Up to 48 months	6.5% 23/352 • Number of events 33 • Up to 48 months
Blood and lymphatic system disorders Febrile neutropenia	4.3% 16/376 • Number of events 18 • Up to 48 months	7.2% 26/363 • Number of events 30 • Up to 48 months	4.3% 15/352 • Number of events 15 • Up to 48 months
Blood and lymphatic system disorders Anaemia	3.7% 14/376 • Number of events 18 • Up to 48 months	3.6% 13/363 • Number of events 16 • Up to 48 months	2.8% 10/352 • Number of events 14 • Up to 48 months
Blood and lymphatic system disorders Thrombocytopenia	3.2% 12/376 • Number of events 14 • Up to 48 months	1.9% 7/363 • Number of events 8 • Up to 48 months	1.7% 6/352 • Number of events 7 • Up to 48 months
Cardiac disorders Cardio-respiratory arrest	0.00% 0/376 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Cardiac disorders Cardiopulmonary failure	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Abdominal pain	2.1% 8/376 • Number of events 9 • Up to 48 months	2.8% 10/363 • Number of events 10 • Up to 48 months	2.0% 7/352 • Number of events 7 • Up to 48 months
Gastrointestinal disorders Vomiting	2.7% 10/376 • Number of events 11 • Up to 48 months	1.7% 6/363 • Number of events 7 • Up to 48 months	2.3% 8/352 • Number of events 10 • Up to 48 months
Gastrointestinal disorders Ascites	1.9% 7/376 • Number of events 10 • Up to 48 months	1.4% 5/363 • Number of events 7 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Gastrointestinal disorders Diarrhoea	1.1% 4/376 • Number of events 4 • Up to 48 months	1.9% 7/363 • Number of events 7 • Up to 48 months	2.3% 8/352 • Number of events 9 • Up to 48 months
Gastrointestinal disorders Intestinal obstruction	1.6% 6/376 • Number of events 6 • Up to 48 months	1.1% 4/363 • Number of events 7 • Up to 48 months	1.4% 5/352 • Number of events 5 • Up to 48 months
Gastrointestinal disorders Ileus	1.3% 5/376 • Number of events 7 • Up to 48 months	0.83% 3/363 • Number of events 3 • Up to 48 months	0.85% 3/352 • Number of events 3 • Up to 48 months
Gastrointestinal disorders Small intestine obstruction	1.1% 4/376 • Number of events 13 • Up to 48 months	0.83% 3/363 • Number of events 3 • Up to 48 months	1.1% 4/352 • Number of events 4 • Up to 48 months
Gastrointestinal disorders Nausea	1.1% 4/376 • Number of events 5 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	2.0% 7/352 • Number of events 7 • Up to 48 months
Gastrointestinal disorders Subileus	0.00% 0/376 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	1.1% 4/352 • Number of events 4 • Up to 48 months
Gastrointestinal disorders Ileus paralytic	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders Pyrexia	1.1% 4/376 • Number of events 6 • Up to 48 months	1.4% 5/363 • Number of events 5 • Up to 48 months	1.7% 6/352 • Number of events 6 • Up to 48 months
General disorders Fatigue	0.80% 3/376 • Number of events 3 • Up to 48 months	0.83% 3/363 • Number of events 3 • Up to 48 months	1.7% 6/352 • Number of events 6 • Up to 48 months
General disorders Disease progression	0.27% 1/376 • Number of events 1 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	1.1% 4/352 • Number of events 4 • Up to 48 months
General disorders Asthenia	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	1.1% 4/352 • Number of events 4 • Up to 48 months
General disorders Death	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders Device failure	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders General physical health deterioration	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders Multi-organ failure	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders Sudden death	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Immune system disorders Drug hypersensitivity	1.9% 7/376 • Number of events 7 • Up to 48 months	1.7% 6/363 • Number of events 6 • Up to 48 months	0.85% 3/352 • Number of events 4 • Up to 48 months
Infections and infestations Pneumonia	0.80% 3/376 • Number of events 3 • Up to 48 months	1.4% 5/363 • Number of events 5 • Up to 48 months	1.4% 5/352 • Number of events 5 • Up to 48 months
Infections and infestations Urinary tract infection	1.3% 5/376 • Number of events 6 • Up to 48 months	0.83% 3/363 • Number of events 3 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Neutropenic sepsis	1.1% 4/376 • Number of events 4 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Infections and infestations Sepsis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 2 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Infections and infestations Biliary tract infection	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Lower respiratory tract infection	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.85% 3/352 • Number of events 3 • Up to 48 months
Infections and infestations Necrotising fasciitis	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Metabolism and nutrition disorders Dehydration	1.1% 4/376 • Number of events 5 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.85% 3/352 • Number of events 4 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pulmomary embolism	0.80% 3/376 • Number of events 3 • Up to 48 months	2.2% 8/363 • Number of events 8 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Blood and lymphatic system disorders Leukopenia	0.27% 1/376 • Number of events 1 • Up to 48 months	0.55% 2/363 • Number of events 3 • Up to 48 months	0.85% 3/352 • Number of events 3 • Up to 48 months
Blood and lymphatic system disorders Agranulocytosis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Blood and lymphatic system disorders Febrile Bone Marrow Aplasia	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Blood and lymphatic system disorders Pancytopenia	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Cardiac disorders Atrial Fibrillation	0.53% 2/376 • Number of events 3 • Up to 48 months	0.83% 3/363 • Number of events 3 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Cardiac disorders Angina Pectoris	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Cardiac disorders Atrial Flutter	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Cardiac disorders Myocardial Ischaemia	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Cardiac disorders Cardiac Failure Congestive	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Cardiac disorders Tachycardia	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Ear and labyrinth disorders Vertigo	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Ear and labyrinth disorders Vertigo Positional	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Eye disorders Retinal Detachment	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Gastrointestinal disorders Constipation	0.80% 3/376 • Number of events 3 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.85% 3/352 • Number of events 3 • Up to 48 months
Gastrointestinal disorders Colitis	0.00% 0/376 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Colonic Obstruction	0.53% 2/376 • Number of events 2 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Abdominal Discomfort	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Abdominal Hernia	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Colitis Ischaemic	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Enteritis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Gastrointestinal disorders Gastric Hypomotility	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Large Intestinal Obstruction	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Gastrointestinal disorders Large Intestine Perforation	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Melaena	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Mesenteric Panniculitis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Pancreatitis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Gastrointestinal disorders Enterocolitis	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Gastrointestinal disorders Umbilical Hernia	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
General disorders Malaise	0.53% 2/376 • Number of events 2 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
General disorders Non-Cardiac Chest Pain	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders Catheter Site Inflammation	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders Chest Discomfort	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
General disorders Chest Pain	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders Hernia	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
General disorders Pain	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
General disorders Chills	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
General disorders Feeling Hot	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
General disorders Multi-Organ Disorder	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Hepatobiliary disorders Hyperbilirubinaemia	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Hepatobiliary disorders Ampulla Of Vater Stenosis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Hepatobiliary disorders Bile Duct Obstruction	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Hepatobiliary disorders Bile Duct Stone	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Hepatobiliary disorders Hepatic Function Abnormal	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Hepatobiliary disorders Jaundice Cholestatic	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Immune system disorders Hypersensitivity	0.80% 3/376 • Number of events 3 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Immune system disorders Anaphylactic Reaction	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.57% 2/352 • Number of events 3 • Up to 48 months
Immune system disorders Anaphylactic Shock	0.00% 0/376 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Abdominal Abscess	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Gastroenteritis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Infection	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 2 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/376 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Bronchiolitis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Catheter Site Infection	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.85% 3/352 • Number of events 3 • Up to 48 months
Infections and infestations Cellulitis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Infections and infestations Clostridial Infection	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Clostridium Difficile Colitis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Infections and infestations Device Related Infection	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Infections and infestations Escherichia Infection	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Herpes Zoster	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Infected Lymphocele	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Influenza	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Klebsiella Sepsis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Lobar Pneumonia	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Malaria	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Nasopharyngitis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Neutropenic Infection	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Infections and infestations Pharyngitis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Psoas Abscess	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Pyelonephritis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Septic Shock	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Staphylococcal Infection	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Subcutaneous Abscess	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Tooth Abscess	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Urinary Tract Infection Bacterial	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Urosepsis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Infections and infestations Herpes Zoster Oticus	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Infections and infestations Infective Exacerbation Of Bronchiectasis	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 2 • Up to 48 months
Infections and infestations Pneumonia Cryptococcal	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Infections and infestations Pyelonephritis Acute	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Injury, poisoning and procedural complications Contusion	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Injury, poisoning and procedural complications Femur Fracture	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Injury, poisoning and procedural complications Rib Fracture	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Injury, poisoning and procedural complications Vascular Access Complication	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Injury, poisoning and procedural complications Wrist Fracture	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Injury, poisoning and procedural complications Joint Injury	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Injury, poisoning and procedural complications Post Procedural Discomfort	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Investigations Platelet Count Decreased	0.53% 2/376 • Number of events 2 • Up to 48 months	0.83% 3/363 • Number of events 3 • Up to 48 months	0.00% 0/352 • Up to 48 months
Investigations Blood Creatinine Increased	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Investigations Activated Partial Thromboplastin Time Prolonged	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Investigations Alanine Aminotransferase Increased	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Investigations C-Reactive Protein Increased	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 2 • Up to 48 months	0.00% 0/352 • Up to 48 months
Investigations Haemoglobin Decreased	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Investigations International Normalised Ratio Increased	0.27% 1/376 • Number of events 2 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Investigations White Blood Cell Count Decreased	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Investigations Aspartate Aminotransferase Increased	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Investigations Blood Magnesium Decreased	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Investigations Chest X-Ray Abnormal	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Investigations Clostridium Test Positive	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Metabolism and nutrition disorders Hypokalaemia	0.80% 3/376 • Number of events 4 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.85% 3/352 • Number of events 4 • Up to 48 months
Metabolism and nutrition disorders Hypomagnesaemia	0.27% 1/376 • Number of events 1 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/376 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.00% 0/352 • Up to 48 months
Metabolism and nutrition disorders Hypocalcaemia	0.53% 2/376 • Number of events 2 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Metabolism and nutrition disorders Failure To Thrive	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Metabolism and nutrition disorders Electrolyte Imbalance	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Musculoskeletal and connective tissue disorders Back Pain	0.53% 2/376 • Number of events 2 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Musculoskeletal and connective tissue disorders Joint Swelling	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Musculoskeletal and connective tissue disorders Pain In Extremity	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Adrenals	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Lung	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Spleen	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer Recurrent	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Associated Fever	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Nervous system disorders Cerebrovascular Accident	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Nervous system disorders Convulsion	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Nervous system disorders Dizziness	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Nervous system disorders Guillain-Barre Syndrome	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Nervous system disorders Headache	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Nervous system disorders Neuropathy Peripheral	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Nervous system disorders Petit Mal Epilepsy	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Nervous system disorders Sciatica	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Nervous system disorders Transient Ischaemic Attack	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Nervous system disorders Paraesthesia	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Nervous system disorders Presyncope	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Psychiatric disorders Confusional State	0.27% 1/376 • Number of events 2 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Psychiatric disorders Mental Status Changes	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Psychiatric disorders Panic Attack	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Renal and urinary disorders Renal Failure Acute	0.53% 2/376 • Number of events 2 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Renal and urinary disorders Hydronephrosis	0.53% 2/376 • Number of events 2 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Renal and urinary disorders Haematuria	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Renal and urinary disorders Nephrolithiasis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Renal and urinary disorders Renal Impairment	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Renal and urinary disorders Renal Vein Thrombosis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Renal and urinary disorders Urogenital Haemorrhage	0.27% 1/376 • Number of events 2 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Renal and urinary disorders Renal Failure	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/376 • Up to 48 months	0.83% 3/363 • Number of events 3 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Reproductive system and breast disorders Female Genital Tract Fistula	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.53% 2/376 • Number of events 3 • Up to 48 months	0.28% 1/363 • Number of events 2 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/376 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pulmonary Artery Thrombosis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Cough	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Obliterative Bronchiolitis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Skin and subcutaneous tissue disorders Rash	0.00% 0/376 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.00% 0/352 • Up to 48 months
Skin and subcutaneous tissue disorders Pruritus	0.27% 1/376 • Number of events 2 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Surgical and medical procedures Malignant Tumour Excision	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Surgical and medical procedures Mass Excision	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Surgical and medical procedures Ureteral Stent Insertion	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Surgical and medical procedures Cytoreductive Surgery	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.57% 2/352 • Number of events 2 • Up to 48 months
Vascular disorders Deep Vein Thrombosis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.55% 2/363 • Number of events 2 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Vascular disorders Embolism	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Vascular disorders Flushing	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 2 • Up to 48 months	0.00% 0/352 • Up to 48 months
Vascular disorders Hot Flush	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Vascular disorders Hypotension	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Vascular disorders Vena Cava Thrombosis	0.27% 1/376 • Number of events 1 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.00% 0/352 • Up to 48 months
Vascular disorders Venous Thrombosis	0.00% 0/376 • Up to 48 months	0.28% 1/363 • Number of events 1 • Up to 48 months	0.00% 0/352 • Up to 48 months
Vascular disorders Peripheral Ischaemia	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months
Vascular disorders Thrombophlebitis	0.00% 0/376 • Up to 48 months	0.00% 0/363 • Up to 48 months	0.28% 1/352 • Number of events 1 • Up to 48 months

Other adverse events

Measure	1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin n=376 participants at risk Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin n=363 participants at risk Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).	Placebo Plus Taxane and Carboplatin n=352 participants at risk Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).
Gastrointestinal disorders Nausea	57.2% 215/376 • Number of events 486 • Up to 48 months	51.0% 185/363 • Number of events 395 • Up to 48 months	53.4% 188/352 • Number of events 459 • Up to 48 months
Gastrointestinal disorders Diarrhoea	35.6% 134/376 • Number of events 251 • Up to 48 months	34.4% 125/363 • Number of events 207 • Up to 48 months	35.8% 126/352 • Number of events 262 • Up to 48 months
Gastrointestinal disorders Vomiting	34.3% 129/376 • Number of events 224 • Up to 48 months	30.3% 110/363 • Number of events 167 • Up to 48 months	29.3% 103/352 • Number of events 211 • Up to 48 months
Gastrointestinal disorders Constipation	31.6% 119/376 • Number of events 167 • Up to 48 months	29.2% 106/363 • Number of events 164 • Up to 48 months	28.7% 101/352 • Number of events 155 • Up to 48 months
Gastrointestinal disorders Abdominal pain	28.2% 106/376 • Number of events 155 • Up to 48 months	23.1% 84/363 • Number of events 122 • Up to 48 months	25.9% 91/352 • Number of events 149 • Up to 48 months
Gastrointestinal disorders Abdominal pain upper	12.2% 46/376 • Number of events 55 • Up to 48 months	12.9% 47/363 • Number of events 54 • Up to 48 months	11.6% 41/352 • Number of events 51 • Up to 48 months
Gastrointestinal disorders Dyspepsia	11.7% 44/376 • Number of events 57 • Up to 48 months	9.6% 35/363 • Number of events 46 • Up to 48 months	9.7% 34/352 • Number of events 47 • Up to 48 months
Gastrointestinal disorders Stomatitis	9.6% 36/376 • Number of events 52 • Up to 48 months	6.9% 25/363 • Number of events 28 • Up to 48 months	9.4% 33/352 • Number of events 58 • Up to 48 months
Gastrointestinal disorders Abdominal distension	7.2% 27/376 • Number of events 28 • Up to 48 months	6.9% 25/363 • Number of events 29 • Up to 48 months	6.8% 24/352 • Number of events 30 • Up to 48 months
Blood and lymphatic system disorders Neutropenia	54.5% 205/376 • Number of events 622 • Up to 48 months	51.0% 185/363 • Number of events 584 • Up to 48 months	48.0% 169/352 • Number of events 639 • Up to 48 months
Blood and lymphatic system disorders Anaemia	37.0% 139/376 • Number of events 214 • Up to 48 months	42.4% 154/363 • Number of events 265 • Up to 48 months	34.1% 120/352 • Number of events 193 • Up to 48 months
Blood and lymphatic system disorders Thrombocytopenia	33.5% 126/376 • Number of events 351 • Up to 48 months	33.3% 121/363 • Number of events 296 • Up to 48 months	28.1% 99/352 • Number of events 237 • Up to 48 months
Blood and lymphatic system disorders Leukopenia	19.7% 74/376 • Number of events 283 • Up to 48 months	19.8% 72/363 • Number of events 194 • Up to 48 months	21.0% 74/352 • Number of events 282 • Up to 48 months
Blood and lymphatic system disorders Lymphopenia	5.6% 21/376 • Number of events 63 • Up to 48 months	4.1% 15/363 • Number of events 39 • Up to 48 months	6.0% 21/352 • Number of events 85 • Up to 48 months
General disorders Fatigue	45.5% 171/376 • Number of events 319 • Up to 48 months	37.2% 135/363 • Number of events 206 • Up to 48 months	42.3% 149/352 • Number of events 319 • Up to 48 months
General disorders Asthenia	20.2% 76/376 • Number of events 162 • Up to 48 months	23.1% 84/363 • Number of events 174 • Up to 48 months	18.2% 64/352 • Number of events 134 • Up to 48 months
General disorders Pyrexia	15.4% 58/376 • Number of events 92 • Up to 48 months	12.9% 47/363 • Number of events 67 • Up to 48 months	13.6% 48/352 • Number of events 73 • Up to 48 months
General disorders Oedema peripheral	11.4% 43/376 • Number of events 98 • Up to 48 months	10.2% 37/363 • Number of events 43 • Up to 48 months	11.4% 40/352 • Number of events 49 • Up to 48 months
General disorders Pain	8.5% 32/376 • Number of events 43 • Up to 48 months	7.2% 26/363 • Number of events 31 • Up to 48 months	5.4% 19/352 • Number of events 24 • Up to 48 months
General disorders Mucosal inflammation	8.2% 31/376 • Number of events 37 • Up to 48 months	6.6% 24/363 • Number of events 28 • Up to 48 months	8.5% 30/352 • Number of events 51 • Up to 48 months
Skin and subcutaneous tissue disorders Alopecia	58.8% 221/376 • Number of events 225 • Up to 48 months	50.7% 184/363 • Number of events 186 • Up to 48 months	57.4% 202/352 • Number of events 207 • Up to 48 months
Skin and subcutaneous tissue disorders Rash	13.0% 49/376 • Number of events 60 • Up to 48 months	11.0% 40/363 • Number of events 52 • Up to 48 months	11.1% 39/352 • Number of events 77 • Up to 48 months
Skin and subcutaneous tissue disorders Pruritus	13.8% 52/376 • Number of events 93 • Up to 48 months	9.9% 36/363 • Number of events 56 • Up to 48 months	10.5% 37/352 • Number of events 66 • Up to 48 months
Nervous system disorders Peripheral sensory neuropathy	23.7% 89/376 • Number of events 138 • Up to 48 months	19.6% 71/363 • Number of events 117 • Up to 48 months	25.6% 90/352 • Number of events 121 • Up to 48 months
Nervous system disorders Headache	21.0% 79/376 • Number of events 125 • Up to 48 months	21.8% 79/363 • Number of events 131 • Up to 48 months	20.2% 71/352 • Number of events 137 • Up to 48 months
Nervous system disorders Dizziness	17.3% 65/376 • Number of events 80 • Up to 48 months	14.3% 52/363 • Number of events 69 • Up to 48 months	10.5% 37/352 • Number of events 53 • Up to 48 months
Nervous system disorders Dysgeusia	14.1% 53/376 • Number of events 69 • Up to 48 months	14.0% 51/363 • Number of events 65 • Up to 48 months	14.8% 52/352 • Number of events 87 • Up to 48 months
Nervous system disorders Neuropathy peripheral	9.8% 37/376 • Number of events 47 • Up to 48 months	12.1% 44/363 • Number of events 53 • Up to 48 months	11.4% 40/352 • Number of events 49 • Up to 48 months
Nervous system disorders Paraesthesia	6.9% 26/376 • Number of events 55 • Up to 48 months	6.6% 24/363 • Number of events 48 • Up to 48 months	8.0% 28/352 • Number of events 54 • Up to 48 months
Nervous system disorders Hypoaesthesia	6.1% 23/376 • Number of events 34 • Up to 48 months	4.4% 16/363 • Number of events 30 • Up to 48 months	3.4% 12/352 • Number of events 22 • Up to 48 months
Musculoskeletal and connective tissue disorders Arthralgia	24.7% 93/376 • Number of events 193 • Up to 48 months	18.2% 66/363 • Number of events 123 • Up to 48 months	24.4% 86/352 • Number of events 170 • Up to 48 months
Musculoskeletal and connective tissue disorders Myaligia	18.1% 68/376 • Number of events 116 • Up to 48 months	17.4% 63/363 • Number of events 95 • Up to 48 months	15.3% 54/352 • Number of events 108 • Up to 48 months
Musculoskeletal and connective tissue disorders Pain in extremity	13.8% 52/376 • Number of events 69 • Up to 48 months	13.2% 48/363 • Number of events 72 • Up to 48 months	13.4% 47/352 • Number of events 63 • Up to 48 months
Musculoskeletal and connective tissue disorders Back pain	15.4% 58/376 • Number of events 80 • Up to 48 months	8.3% 30/363 • Number of events 34 • Up to 48 months	14.2% 50/352 • Number of events 70 • Up to 48 months
Musculoskeletal and connective tissue disorders Bone pain	6.4% 24/376 • Number of events 26 • Up to 48 months	7.4% 27/363 • Number of events 34 • Up to 48 months	9.1% 32/352 • Number of events 55 • Up to 48 months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.5% 17/376 • Number of events 21 • Up to 48 months	4.4% 16/363 • Number of events 23 • Up to 48 months	7.1% 25/352 • Number of events 29 • Up to 48 months
Metabolism and nutrition disorders Decreased appetite	25.3% 95/376 • Number of events 195 • Up to 48 months	20.4% 74/363 • Number of events 137 • Up to 48 months	19.9% 70/352 • Number of events 167 • Up to 48 months
Metabolism and nutrition disorders Hypomagnesaemia	8.8% 33/376 • Number of events 55 • Up to 48 months	9.1% 33/363 • Number of events 42 • Up to 48 months	7.4% 26/352 • Number of events 32 • Up to 48 months
Metabolism and nutrition disorders Hypokalaemia	7.7% 29/376 • Number of events 54 • Up to 48 months	9.4% 34/363 • Number of events 54 • Up to 48 months	5.7% 20/352 • Number of events 31 • Up to 48 months
Metabolism and nutrition disorders Hyperglycemia	4.8% 18/376 • Number of events 29 • Up to 48 months	5.8% 21/363 • Number of events 26 • Up to 48 months	3.7% 13/352 • Number of events 15 • Up to 48 months
Metabolism and nutrition disorders Dehydration	5.1% 19/376 • Number of events 25 • Up to 48 months	4.1% 15/363 • Number of events 21 • Up to 48 months	5.4% 19/352 • Number of events 22 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Cough	20.5% 77/376 • Number of events 101 • Up to 48 months	16.8% 61/363 • Number of events 84 • Up to 48 months	15.9% 56/352 • Number of events 66 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.2% 46/376 • Number of events 60 • Up to 48 months	14.6% 53/363 • Number of events 67 • Up to 48 months	9.9% 35/352 • Number of events 47 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 29/376 • Number of events 29 • Up to 48 months	6.9% 25/363 • Number of events 27 • Up to 48 months	6.8% 24/352 • Number of events 30 • Up to 48 months
Infections and infestations Urinary tract infection	12.8% 48/376 • Number of events 65 • Up to 48 months	11.3% 41/363 • Number of events 66 • Up to 48 months	9.7% 34/352 • Number of events 48 • Up to 48 months
Infections and infestations Upper respiratory tract infection	10.1% 38/376 • Number of events 45 • Up to 48 months	10.5% 38/363 • Number of events 59 • Up to 48 months	8.0% 28/352 • Number of events 35 • Up to 48 months
Infections and infestations Nasopharyngitis	12.2% 46/376 • Number of events 63 • Up to 48 months	7.7% 28/363 • Number of events 35 • Up to 48 months	11.6% 41/352 • Number of events 64 • Up to 48 months
Psychiatric disorders Insomnia	12.5% 47/376 • Number of events 61 • Up to 48 months	10.7% 39/363 • Number of events 41 • Up to 48 months	12.5% 44/352 • Number of events 62 • Up to 48 months
Psychiatric disorders Anxiety	6.4% 24/376 • Number of events 28 • Up to 48 months	8.0% 29/363 • Number of events 31 • Up to 48 months	4.3% 15/352 • Number of events 15 • Up to 48 months
Vascular disorders Flushing	6.6% 25/376 • Number of events 34 • Up to 48 months	5.2% 19/363 • Number of events 36 • Up to 48 months	6.2% 22/352 • Number of events 29 • Up to 48 months
Vascular disorders Hypotension	5.6% 21/376 • Number of events 24 • Up to 48 months	3.3% 12/363 • Number of events 16 • Up to 48 months	4.0% 14/352 • Number of events 16 • Up to 48 months
Vascular disorders Hot flush	4.3% 16/376 • Number of events 29 • Up to 48 months	4.4% 16/363 • Number of events 17 • Up to 48 months	6.0% 21/352 • Number of events 38 • Up to 48 months
Immune system disorders Drug hypersensitivity	10.9% 41/376 • Number of events 60 • Up to 48 months	14.3% 52/363 • Number of events 94 • Up to 48 months	15.1% 53/352 • Number of events 91 • Up to 48 months
Eye disorders Lacrimation increased	5.3% 20/376 • Number of events 22 • Up to 48 months	2.8% 10/363 • Number of events 10 • Up to 48 months	2.3% 8/352 • Number of events 8 • Up to 48 months
Gastrointestinal disorders ABDOMINAL PAIN LOWER	5.1% 19/376 • Number of events 21 • Up to 48 months	4.4% 16/363 • Number of events 18 • Up to 48 months	5.4% 19/352 • Number of events 22 • Up to 48 months
Gastrointestinal disorders FLATULENCE	5.3% 20/376 • Number of events 24 • Up to 48 months	5.5% 20/363 • Number of events 20 • Up to 48 months	4.8% 17/352 • Number of events 20 • Up to 48 months
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	5.9% 22/376 • Number of events 23 • Up to 48 months	7.2% 26/363 • Number of events 29 • Up to 48 months	5.7% 20/352 • Number of events 24 • Up to 48 months
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	4.3% 16/376 • Number of events 17 • Up to 48 months	5.2% 19/363 • Number of events 20 • Up to 48 months	1.7% 6/352 • Number of events 6 • Up to 48 months
Respiratory, thoracic and mediastinal disorders Epistaxis	5.9% 22/376 • Number of events 30 • Up to 48 months	5.0% 18/363 • Number of events 19 • Up to 48 months	4.3% 15/352 • Number of events 21 • Up to 48 months
Infections and infestations Cystitis	3.2% 12/376 • Number of events 14 • Up to 48 months	1.4% 5/363 • Number of events 6 • Up to 48 months	5.4% 19/352 • Number of events 23 • Up to 48 months
Psychiatric disorders Depression	6.9% 26/376 • Number of events 26 • Up to 48 months	5.0% 18/363 • Number of events 19 • Up to 48 months	2.3% 8/352 • Number of events 8 • Up to 48 months
Vascular disorders Hypertension	3.2% 12/376 • Number of events 19 • Up to 48 months	3.9% 14/363 • Number of events 22 • Up to 48 months	5.4% 19/352 • Number of events 22 • Up to 48 months
Investigations Weight decreased	4.0% 15/376 • Number of events 21 • Up to 48 months	5.2% 19/363 • Number of events 19 • Up to 48 months	4.0% 14/352 • Number of events 17 • Up to 48 months
Renal and urinary disorders Dysuria	6.1% 23/376 • Number of events 25 • Up to 48 months	5.5% 20/363 • Number of events 23 • Up to 48 months	4.5% 16/352 • Number of events 20 • Up to 48 months

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: esi_oncmedinfo@eisai.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER