Trial Outcomes & Findings for A Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00558636)

Last Updated: 2013-12-27

Results Overview

Progression free survival (PFS) is the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented. Since the study was terminated early and 89% of subjects' data were censored, only the number of PFS events (Failed \[progressed or died before progression\]) is reported, not the usual measure "number of days".

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

91 participants

Primary outcome timeframe

Up to 5 months after randomization of the first patient

Results posted on

2013-12-27

Participant Flow

Subjects were recruited from 23 Sep 2007 to 12 May 2008 (first subject's first visit to last subject's last visit) at 15 centers in 4 countries: China (9), Singapore (2), Thailand (2), and Taiwan (2). The study was terminated prematurely after about 5 months of recruitment and before the planned 230 progression free survival (PFS) events occurred.

At the time of study termination, 91 (out of 108 screened subjects) of the planned 294 subjects had been screened and randomized. All 91 randomized subjects received at least 1 dose of study drug and were included in both the intent-to-treat (ITT) and safety analysis populations.

Participant milestones

Participant milestones
Measure	Sorafenib + Paclitaxel + Carboplatin Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Treatment STARTED	47	44
Treatment Start of Maintenance Monotherapy	2	2
Treatment COMPLETED	0	0
Treatment NOT COMPLETED	47	44
Follow-up STARTED	12	7
Follow-up COMPLETED	0	0
Follow-up NOT COMPLETED	12	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib + Paclitaxel + Carboplatin Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Treatment Adverse Event	9	2
Treatment Withdrawal by Subject	2	0
Treatment Premature termination of the study	35	37
Treatment Disease progression	1	5
Follow-up Premature termination of the study	12	7

Baseline Characteristics

A Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib + Paclitaxel + Carboplatin n=47 Participants Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=44 Participants Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants	32 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	56.2 years STANDARD_DEVIATION 9.3 • n=5 Participants	55.4 years STANDARD_DEVIATION 12.6 • n=7 Participants	55.8 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	30 Participants n=7 Participants	57 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0: Fully active	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status Grade 1: Restricted strenuous activity, ambulatory	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Geographic region China	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Geographic region Non-China	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Histology Squamous cell (epidermoid) carcinoma	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Histology Other	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Histology Missing histology	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Stage at study entry Missing	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Stage at study entry Stage IIIB	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Stage at study entry Stage IV	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 months after randomization of the first patient

Population: It was intended to include all randomized subjects (the intent to treat (ITT) population) in the analysis. Since 89% of subjects were censored, PFS could not be calculated. The number of subjects who Failed (progressed or died before progression) or were Censored are reported.

Outcome measures

Outcome measures
Measure	Sorafenib + Paclitaxel + Carboplatin n=47 Participants Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=44 Participants Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Progression Free Survival Failed (progressed or died before progression)	5 Participants	5 Participants
Progression Free Survival Censored	42 Participants	39 Participants

SECONDARY outcome

Timeframe: Up to 5 months after randomization of the first patient

Population: All randomized subjects (the intent to treat (ITT) population) were included in the analysis. Since 89% of subjects were censored, OS could not be calculated. The number of subjects who Failed (died) or were Censored are reported.

Overall survival is the number of days from the date of randomization to the date of death due to any cause. Subjects alive at the time of analysis were censored at their last date of follow-up. Since the study was terminated early and 89% of subjects' data were censored, only the number of subjects who Failed (died) or were Censored is reported, not the usual measure "number of days".

Outcome measures

Outcome measures
Measure	Sorafenib + Paclitaxel + Carboplatin n=47 Participants Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=44 Participants Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Overall Survival (OS) Censored	43 Participants	43 Participants
Overall Survival (OS) Failed (died)	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Best tumor response assessed every 6 weeks by investigator during treatment up to 5 months after randomization of the first patient.

Population: All randomized subjects (the intent to treat (ITT) population) were included in the analysis.

Complete response (CR): Disappearance of all target lesions (TL). Partial response (PR): At least 30% decrease in sum of the largest diameter (LD) of TLs, taking baseline sum as reference. Stable disease (SD): No change in tumor size. Progressive disease (PD): At least a 20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since treatment started, or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Sorafenib + Paclitaxel + Carboplatin n=47 Participants Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=44 Participants Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST) Complete repsonse (CR)	0 Participants	0 Participants
Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST) Stable disease (SD)	18 Participants	28 Participants
Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST) Partial response (PR)	4 Participants	0 Participants
Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST) Progressive disease (PD)	1 Participants	1 Participants
Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST) not evaluated	24 Participants	15 Participants

SECONDARY outcome

Timeframe: Time from first documented objective response (complete response or partial response) to disease progression or death, or to last tumor assessment if censored, up to 5 months after randomization of the first patient.

Population: All subjects that showed a response. Since only 4 subjects had a response, the data were not analyzed.

Duration of response (PR or better) was defined as the time from the first documented objective PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Since only 4 subjects had a response, the duration of response was not calculated.

Outcome measures

Outcome measures
Measure	Sorafenib + Paclitaxel + Carboplatin n=4 Participants Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Duration of Response The second subject who showed a response	45 days	—
Duration of Response The third subject who showed a response	46 days	—
Duration of Response The fourth subject who showed a response	53 days	—
Duration of Response The first subject who showed a response	91 days	—

SECONDARY outcome

Timeframe: Change from baseline of LCS score assessed at each treatment cycle starting with Cycle 2 (Cycles 2, 3, 4, 5, 6, 7; 21 days per cycle) up to 5 months after randomization of the first patient.

Population: Of the 91 randomized subjects in the ITT population, 90 completed the LCS at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the response rate (number of evaluable subjects completing the questionnaire) decreased from cycle to cycle and makes the results hard to interpret.

The LCS is a validated instrument for determining treatment impact on lung symptoms. The LCS consists of 7 questions with 5 responses ranging from "not at all" to "very much". The LCS total score ranges from 0 to 28. Lower scores reflect greater lung cancer symptoms.

Outcome measures

Outcome measures
Measure	Sorafenib + Paclitaxel + Carboplatin n=47 Participants Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=43 Participants Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2 Cycle 2 (N = 31 sorafenib/33 placebo)	2.8 units on a scale Standard Deviation 10.0	1.1 units on a scale Standard Deviation 5.6
Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2 Cycle 3 (N = 16 sorafenib/23 placebo)	0.4 units on a scale Standard Deviation 3.6	0.2 units on a scale Standard Deviation 13.2
Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2 Cycle 4 (N = 12 sorafenib/14 placebo)	-0.1 units on a scale Standard Deviation 3.0	2.2 units on a scale Standard Deviation 4.2
Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2 Cycle 5 (N = 7 sorafenib/5 placebo)	2.4 units on a scale Standard Deviation 2.7	3.6 units on a scale Standard Deviation 4.5
Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2 Cycle 6 (N = 4 sorafenib/3 placebo)	-0.8 units on a scale Standard Deviation 2.9	4.3 units on a scale Standard Deviation 8.6
Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2 Cycle 7 (N = 2 sorafenib/1 placebo)	3.0 units on a scale Standard Deviation 2.8	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Change from baseline of HRQoL score assessed (at treatment Cycle 3 and Cycles 5 [21 days per cycle]) up to 5 months after randomization of the first patient.

Population: Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.

HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.

Outcome measures

Outcome measures
Measure	Sorafenib + Paclitaxel + Carboplatin n=46 Participants Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=42 Participants Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 3 and Cycle 5 Cycle 3 (N = 16 sorafenib/21 placebo)	-5.1 units on a scale Standard Deviation 10.6	4.6 units on a scale Standard Deviation 19.5
Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 3 and Cycle 5 Cycle 5 (N = 7 sorafenib/5 placebo)	0 units on a scale Standard Deviation 9.9	11.2 units on a scale Standard Deviation 27.8

SECONDARY outcome

Timeframe: Change from baseline of HRQoL score assessed (at treatment Cycle 7 [21 days per cycle]) up to 5 months after randomization of the first patient.

Outcome measures

Outcome measures
Measure	Sorafenib + Paclitaxel + Carboplatin n=2 Participants Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=1 Participants Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 7	13.5 Units on a scale Standard Deviation 6.4	11.3 Units on a scale

Adverse Events

Sorafenib + Paclitaxel + Carboplatin

Serious events: 11 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo + Paclitaxel + Carboplatin

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib + Paclitaxel + Carboplatin n=47 participants at risk Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=44 participants at risk Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Immune system disorders Allergic reaction	0.00% 0/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	2.3% 1/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Blood and lymphatic system disorders Neutrophiles	2.1% 1/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Skin and subcutaneous tissue disorders Erythema multiforme	4.3% 2/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Skin and subcutaneous tissue disorders Rash/Desquamation	4.3% 2/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Infections and infestations Febrile Neutropenia	6.4% 3/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Infections and infestations Infection (documented clinically), Lung (Pneumonia)	2.1% 1/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Infections and infestations Infection with normal ANC, blood	2.1% 1/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
General disorders Pain, abdomen NOS	2.1% 1/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	2.1% 1/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	2.3% 1/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Respiratory, thoracic and mediastinal disorders Hypoxia	2.1% 1/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.1% 1/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.1% 1/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Vascular disorders Thrombosis/Embolism (vascular access)	0.00% 0/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	2.3% 1/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)

Other adverse events

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Sorafenib + Paclitaxel + Carboplatin n=47 participants at risk Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.	Placebo + Paclitaxel + Carboplatin n=44 participants at risk Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Blood and lymphatic system disorders Hemoglobin	25.5% 12/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	11.4% 5/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Blood and lymphatic system disorders Leukocytes	29.8% 14/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	22.7% 10/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Blood and lymphatic system disorders Neutrophils	66.0% 31/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	56.8% 25/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Blood and lymphatic system disorders Platelets	38.3% 18/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	15.9% 7/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
General disorders Fatigue	23.4% 11/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	27.3% 12/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
General disorders Fever	27.7% 13/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	6.8% 3/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Skin and subcutaneous tissue disorders Alopecia	38.3% 18/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	36.4% 16/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Skin and subcutaneous tissue disorders Hand-foot skin reaction	40.4% 19/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	4.5% 2/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Skin and subcutaneous tissue disorders Rash/Desquamation	48.9% 23/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	13.6% 6/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Gastrointestinal disorders Anorexia	12.8% 6/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	22.7% 10/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Gastrointestinal disorders Diarrhea	29.8% 14/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	15.9% 7/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Nervous system disorders Neuropathy: sensory	17.0% 8/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	27.3% 12/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Immune system disorders Allergic reaction	12.8% 6/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	4.5% 2/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Blood and lymphatic system disorders Lymphopenia	8.5% 4/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	9.1% 4/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Cardiac disorders Supraventricular arrhythmia, sinus tachycardia	0.00% 0/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	6.8% 3/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Cardiac disorders Hypertension	17.0% 8/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	2.3% 1/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
General disorders Insomnia	6.4% 3/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	2.3% 1/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Gastrointestinal disorders Constipation	17.0% 8/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	18.2% 8/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Gastrointestinal disorders GI-other	6.4% 3/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Gastrointestinal disorders Nausea	14.9% 7/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	11.4% 5/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Gastrointestinal disorders Vomiting	14.9% 7/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	9.1% 4/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Metabolism and nutrition disorders ALT	10.6% 5/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	6.8% 3/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Metabolism and nutrition disorders Hyperglycemia	12.8% 6/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	6.8% 3/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Metabolism and nutrition disorders Hyperuricemia	4.3% 2/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	6.8% 3/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Metabolism and nutrition disorders Hypokalemia	10.6% 5/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	2.3% 1/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Metabolism and nutrition disorders Hypomagnesemia	4.3% 2/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	9.1% 4/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Metabolism and nutrition disorders Hyponatremia	17.0% 8/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	9.1% 4/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Metabolism and nutrition disorders Hypophosphatemia	12.8% 6/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Metabolism and nutrition disorders Lipase	19.1% 9/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	4.5% 2/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
General disorders Pain, bone	6.4% 3/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	4.5% 2/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
General disorders Pain, extremity-limb	4.3% 2/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	13.6% 6/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
General disorders Pain, joint	4.3% 2/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	15.9% 7/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
General disorders Pain, muscle	14.9% 7/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	18.2% 8/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Respiratory, thoracic and mediastinal disorders Cough	8.5% 4/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	0.00% 0/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	6.4% 3/47 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)	6.8% 3/44 The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)