Trial Outcomes & Findings for A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma (NCT NCT00434252)

NCT ID: NCT00434252

Last Updated: 2017-07-18

Results Overview

Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan-Meier method.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 214 participants
• Primary outcome timeframe: From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.
• Results posted on: 2017-07-18

Participant Flow

Participant milestones

Measure	Carboplatin+Paclitaxel+Placebo Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Study STARTED	71	143
Overall Study Treated	69	143
Overall Study COMPLETED	7	12
Overall Study NOT COMPLETED	64	131

Reasons for withdrawal

Measure	Carboplatin+Paclitaxel+Placebo Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Study Lack of Efficacy	50	100
Overall Study Adverse Event	6	13
Overall Study Death	1	2
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	4	8
Overall Study Withdrawal by Subject	3	7

Baseline Characteristics

A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma

Baseline characteristics by cohort

Measure	Carboplatin+Paclitaxel+Placebo n=71 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=143 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.	Total n=214 Participants Total of all reporting groups
Age, Continuous	58.7 years STANDARD_DEVIATION 12.6 • n=5 Participants	59.1 years STANDARD_DEVIATION 11.3 • n=7 Participants	58.9 years STANDARD_DEVIATION 11.7 • n=5 Participants
Age, Customized <= 65 years	46 participants n=5 Participants	104 participants n=7 Participants	150 participants n=5 Participants
Age, Customized > 65 years	25 participants n=5 Participants	39 participants n=7 Participants	64 participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	45 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	98 Participants n=7 Participants	148 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.

Population: Intent-to-treat (randomized) population. For patients without documentation of disease progression or death on study, PFS was censored at the time of the last tumor assessment.

Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Carboplatin+Paclitaxel+Placebo n=71 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=143 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Progression-free Survival	4.2 months Interval 2.83 to 5.36	5.6 months Interval 4.21 to 6.8

SECONDARY outcome

Timeframe: Up to 102 weeks

Population: Intent-to-treat (randomized) population

Overall survival was defined as the time from randomization to death from any cause. Median OS was estimated using the Kaplan-Meier method. For patients without documentation of death, overall survival will be censored at the time of the last known contact.

Outcome measures

Measure	Carboplatin+Paclitaxel+Placebo n=71 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=143 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Overall Survival (OS)	8.6 months Interval 7.66 to 11.83	12.3 months Interval 10.35 to Upper limit of confidence interval not estimable due to very small number of deaths occurring after median was reached.

SECONDARY outcome

Timeframe: Up to 102 weeks

Population: Intent-to-treat (randomized) population.

Objective response was assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and was inclusive of complete and partial response determined on two consecutive investigator assessments conducted ≥ 4 weeks apart.

Outcome measures

Measure	Carboplatin+Paclitaxel+Placebo n=67 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=141 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Number of Participants With Objective Response	11 participants Interval 7.5 to 25.3	36 participants Interval 18.3 to 32.7

SECONDARY outcome

Timeframe: Up to 102 weeks

Population: Randomized Patients with Measurable Disease at Baseline

Objective response was defined as a complete or partial response according to RECIST criteria as assessed by the investigator on two consecutive assessments conducted at least 4 weeks apart.

The 95% Confidence Interval (CI) was calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Carboplatin+Paclitaxel+Placebo n=67 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=141 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Percentage of Participants With an Objective Response	16.4 percentage of participants Interval 7.5 to 25.3	25.5 percentage of participants Interval 18.3 to 32.7

SECONDARY outcome

Timeframe: Up to 102 weeks

Population: Intent-to-treat (randomized) population. Only patients with measurable disease who achieved a response (either partial or complete) were included in the analysis of duration of response

Duration of objective response was defined as the time from the initial objective response to documented disease progression or death, whichever occurred first, assessed by the investigator using RECIST. Progressive disease was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Duration of response was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Carboplatin+Paclitaxel+Placebo n=11 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=36 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Duration of Objective Response	7.7 months Interval 3.94 to 11.56	6.9 months Interval 4.86 to 8.9

SECONDARY outcome

Timeframe: 6 months

Population: Intent-to-treat (randomized) population

Six-month Landmark Survival Rate was defined as the percentage of participants surviving at 6 months following randomization. Overall Survival was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Carboplatin+Paclitaxel+Placebo n=71 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=143 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Six-month Landmark Survival Rate	74.6 percentage of participants Interval 64.5 to 84.8	78.2 percentage of participants Interval 71.4 to 85.0

SECONDARY outcome

Timeframe: 24 weeks

Population: Intent-to-treat (randomized) patients

As assessed by the investigator using RECIST and defined as the absence of disease progression for 24 weeks from the time of randomization.

The percentage of patients who did not experience disease progression or death at 24 weeks following randomization was estimated using Kaplan-Meier methodology. If no tumor assessments were performed after the baseline visit, the patient will be censored at the date of randomization plus 1 day.

Outcome measures

Measure	Carboplatin+Paclitaxel+Placebo n=71 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=143 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Twenty-Four Week Landmark Stable Disease	38.0 percentage of participants Interval 26.4 to 49.6	50.2 percentage of participants Interval 41.6 to 58.7

SECONDARY outcome

Timeframe: Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.

Population: The Safety-evaluable population consisted of all patients who received at least one full or partial dose of any component of study treatment.

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Select adverse events included arterial thromboembolic events (any grade), bleeding other than pulmonary or central nervous system (CNS) bleeding (Grade >= 3), CNS bleeding (any grade), febrile neutropenia (any grade), hypertension (Grade >= 3), neutropenia (Grade >= 3), pulmonary bleeding (any grade) and wound dehiscence (Grade >= 3).

*All serious adverse events are listed in the Adverse Event Reporting section.

Outcome measures

Measure	Carboplatin+Paclitaxel+Placebo n=69 Participants Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=143 Participants Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Number of Participants With Select Adverse Events Arterial thromboembolic events (any grade)	1 participants	4 participants
Number of Participants With Select Adverse Events Bleeding other than pulmonary or CNS (Grade >=3)	4 participants	0 participants
Number of Participants With Select Adverse Events CNS bleeding (any grade)	0 participants	1 participants
Number of Participants With Select Adverse Events Febrile neutropenia (any grade)	1 participants	7 participants
Number of Participants With Select Adverse Events Hypertension (Grade >= 3)	0 participants	5 participants
Number of Participants With Select Adverse Events Neutropenia (Grade >= 3)	13 participants	34 participants
Number of Participants With Select Adverse Events Pulmonary bleeding (any grade)	1 participants	2 participants
Number of Participants With Select Adverse Events Wound dehiscence (Grade >= 3)	0 participants	2 participants

Adverse Events

Carboplatin+Paclitaxel+Placebo

Serious events: 20 serious events

Other events: 69 other events

Deaths: 0 deaths

Carboplatin+Paclitaxel+Bevacizumab

Serious events: 40 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Measure	Carboplatin+Paclitaxel+Placebo n=69 participants at risk Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=143 participants at risk Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Blood and lymphatic system disorders Febrile Neutropenia	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	3.5% 5/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Blood and lymphatic system disorders Leukopenia	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Blood and lymphatic system disorders Neutropenia	4.3% 3/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	4.2% 6/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Cardiac disorders Atrial Fibrillation	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Cardiac disorders Myocardial Infarction	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Abdominal Pain	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Diarrhea	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Dysphagia	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Gastrointestinal Hemorrhage	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Hematochezia	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Ileus	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Large Intestinal Hemorrhage	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Nausea	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Small Intestinal Hemorrhage	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Vomiting	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	1.4% 2/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Asthenia	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Chest Pain	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Infusion Related Reaction	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Edema Peripheral	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Pyrexia	4.3% 3/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	1.4% 2/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Sudden Death	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Immune system disorders Anaphylactic Reaction	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Immune system disorders Drug Hypersensitivity	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Abdominal Abscess	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Cellulitis	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Gastroenteritis Viral	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Infected Sebaceous Cyst	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Pneumonia	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	1.4% 2/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Sepsis	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Wound Infection	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Dehydration	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	1.4% 2/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Failure to Thrive	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Hypercalcemia	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Hypoglycemia	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Hypomagnesemia	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	2.1% 3/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Pleural Effusion	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Hemorrhage	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Cerebellar Hemorrhage	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Cerebral Infarction	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Cerebrovascular Accident	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Convulsion	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Embolic Stroke	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Neuropathy Peripheral	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Renal and urinary disorders Calculus Ureteric	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	2.1% 3/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	3.5% 5/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Skin and subcutaneous tissue disorders Photosensitivity Reaction	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Vascular disorders Hypertension	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Vascular disorders Hypotension	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.70% 1/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.

Other adverse events

Measure	Carboplatin+Paclitaxel+Placebo n=69 participants at risk Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.	Carboplatin+Paclitaxel+Bevacizumab n=143 participants at risk Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
Gastrointestinal disorders Nausea	47.8% 33/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	51.0% 73/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Blood and lymphatic system disorders Anaemia	24.6% 17/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	16.1% 23/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Blood and lymphatic system disorders Leukopenia	11.6% 8/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	11.9% 17/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Blood and lymphatic system disorders Neutropenia	21.7% 15/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	27.3% 39/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Blood and lymphatic system disorders Thrombocytopenia	11.6% 8/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	13.3% 19/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Eye disorders Vision Blurred	4.3% 3/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	6.3% 9/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Eye disorders Visual Impairment	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	3.5% 5/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Abdominal Pain	7.2% 5/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.0% 10/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Abdominal Pain Upper	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	5.6% 8/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Constipation	26.1% 18/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	39.9% 57/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Diarrhoea	33.3% 23/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	30.1% 43/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Dry Mouth	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	4.9% 7/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Dyspepsia	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	9.1% 13/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Stomatitis	2.9% 2/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	5.6% 8/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Vomiting	26.1% 18/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	23.1% 33/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Chills	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.0% 10/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Fatigue	73.9% 51/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	71.3% 102/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Mucosal Inflammation	0.00% 0/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.7% 11/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Oedema Peripheral	11.6% 8/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	4.9% 7/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Pain	10.1% 7/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	12.6% 18/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Immune system disorders Hypersensitivity	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	4.9% 7/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Sinusitis	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.0% 10/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Investigations Weight Decreased	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.7% 11/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Anorexia	30.4% 21/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	24.5% 35/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Decreased Appetite	2.9% 2/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	5.6% 8/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Dehydration	8.7% 6/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	1.4% 2/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Hyperglycaemia	4.3% 3/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.7% 11/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Hypokalaemia	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	2.8% 4/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Arthralgia	24.6% 17/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	25.2% 36/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Back Pain	7.2% 5/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	14.0% 20/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Muscular Weakness	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	4.2% 6/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	5.6% 8/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Myalgia	27.5% 19/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	21.0% 30/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Pain In Extremity	13.0% 9/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.7% 11/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Dizziness	8.7% 6/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	14.0% 20/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Dysgeusia	14.5% 10/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	11.2% 16/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Headache	11.6% 8/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	21.7% 31/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Neuropathy Peripheral	31.9% 22/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	35.7% 51/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Paraesthesia	7.2% 5/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.7% 11/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Peripheral Sensory Neuropathy	11.6% 8/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	13.3% 19/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Psychiatric disorders Anxiety	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	6.3% 9/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Psychiatric disorders Depression	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.0% 10/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Psychiatric disorders Insomnia	7.2% 5/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	9.8% 14/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Respiratory, thoracic and mediastinal disorders Cough	24.6% 17/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	16.8% 24/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.4% 1/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.0% 10/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.6% 8/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	19.6% 28/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	39.9% 57/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Skin and subcutaneous tissue disorders Alopecia	60.9% 42/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	58.7% 84/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.8% 4/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Skin and subcutaneous tissue disorders Night Sweats	7.2% 5/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	3.5% 5/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Skin and subcutaneous tissue disorders Pruritus	8.7% 6/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	8.4% 12/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Skin and subcutaneous tissue disorders Rash	20.3% 14/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	11.2% 16/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Vascular disorders Flushing	2.9% 2/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	7.7% 11/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.
Vascular disorders Hypertension	14.5% 10/69 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.	22.4% 32/143 • Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination Safety-evaluable population. 71 patients were randomized to the Carboplatin + Paclitaxel + Placebo arm but only 69 went on to receive study treatment Note: The incidence of each AE/SAE is reported as the number of patients experiencing the event, not the number of occurrences for each AE/SAE.

Additional Information

Medical Communications

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Phone: 800-821-8590

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER