Trial Outcomes & Findings for Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer (NCT NCT00791778)

Last Updated: 2015-09-28

Results Overview

Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

246 participants

Primary outcome timeframe

From randomization of the first patient until 32.5 months later, assessed every 8 weeks

Results posted on

2015-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafenib (Nexavar, BAY43-9006) Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo Participants received 2 matching placebo tablets per oral twice daily
Double-blind Treatment STARTED	123	123
Double-blind Treatment COMPLETED	46	75
Double-blind Treatment NOT COMPLETED	77	48
Follow-up STARTED	100	91
Follow-up COMPLETED	95	90
Follow-up NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib (Nexavar, BAY43-9006) Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo Participants received 2 matching placebo tablets per oral twice daily
Double-blind Treatment Adverse Event	49	9
Double-blind Treatment Physician Decision	6	26
Double-blind Treatment Protocol Violation	0	4
Double-blind Treatment Withdrawal by Subject	20	9
Double-blind Treatment Non-compliant with study medication	2	0
Follow-up Withdrawal by Subject	3	0
Follow-up Lost to Follow-up	2	1

Baseline Characteristics

Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib (Nexavar, BAY43-9006) n=123 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=123 Participants Participants received 2 matching placebo tablets per oral twice daily	Total n=246 Participants Total of all reporting groups
Age, Continuous	56.9 Years STANDARD_DEVIATION 10.4 • n=5 Participants	54.4 Years STANDARD_DEVIATION 10.3 • n=7 Participants	55.7 Years STANDARD_DEVIATION 10.4 • n=5 Participants
Age, Customized < 65 years	95 Participants n=5 Participants	99 Participants n=7 Participants	194 Participants n=5 Participants
Age, Customized ≥ 65 - < 75 years	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Age, Customized ≥ 75 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	123 Participants n=7 Participants	246 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Performance status, Eastern Cooperative Oncology Group (ECOG) 0=Fully active without restriction	89 Participants n=5 Participants	92 Participants n=7 Participants	181 Participants n=5 Participants
Performance status, Eastern Cooperative Oncology Group (ECOG) 1=Restricted in physically strenuous activity	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Performance status, Eastern Cooperative Oncology Group (ECOG) 2=Ambulatory, capable of all selfcare	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Performance status, Eastern Cooperative Oncology Group (ECOG) Missing	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Type of cancer Ovarian cancer	115 Participants n=5 Participants	114 Participants n=7 Participants	229 Participants n=5 Participants
Type of cancer Peritoneal cancer	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Previous Intra-peritoneal (IP) chemotherapy Yes	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Previous Intra-peritoneal (IP) chemotherapy No	118 Participants n=5 Participants	119 Participants n=7 Participants	237 Participants n=5 Participants
Surgical cytoreduction Optimal	105 Participants n=5 Participants	105 Participants n=7 Participants	210 Participants n=5 Participants
Surgical cytoreduction Suboptimal	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Surgical cytoreduction Missing	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization of the first patient until 32.5 months later, assessed every 8 weeks

Population: Full analysis set (FAS)=all randomized participants

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=123 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=123 Participants Participants received 2 matching placebo tablets per oral twice daily
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment	386 Days Interval 230.0 to 691.0	478 Days Interval 337.0 to 567.0

SECONDARY outcome

Timeframe: From randomization of the first patient until 32.5 months later, assessed every 8 weeks

Population: Per protocol set (PPS)=all randomized participants who had normal CA-125 serum level at baseline and at least one post-baseline CA-125 assessment

Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=119 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=111 Participants Participants received 2 matching placebo tablets per oral twice daily
Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level	337 Days Interval 197.0 to Can't be estimated due to censored data.	617 Days Interval 392.0 to Can't be estimated due to censored data.

SECONDARY outcome

Timeframe: From randomization of the first patient until 32.5 months later

Population: FAS=all randomized participants

The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=123 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=123 Participants Participants received 2 matching placebo tablets per oral twice daily
Overall Survival (OS)	NA Days Can't be estimated due to censored data.	NA Days Can't be estimated due to censored data.

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 1 (4 weeks per Cycle)/baseline

Population: Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment

The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=104 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=115 Participants Participants received 2 matching placebo tablets per oral twice daily
Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline	25.909 Scores on a scale Standard Deviation 3.174	25.658 Scores on a scale Standard Deviation 3.968

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 3 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=70 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=105 Participants Participants received 2 matching placebo tablets per oral twice daily
FOSI Total Score at Cycle 3	25.871 Scores on a scale Standard Deviation 3.166	26.105 Scores on a scale Standard Deviation 3.414

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 3 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3

The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=70 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=105 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in FOSI Total Score at Cycle 3	0.086 Scores on a scale Standard Deviation 3.387	0.460 Scores on a scale Standard Deviation 3.128

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 5 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=57 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=93 Participants Participants received 2 matching placebo tablets per oral twice daily
FOSI Total Score at Cycle 5	25.496 Scores on a scale Standard Deviation 3.830	26.634 Scores on a scale Standard Deviation 2.922

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 5 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5

The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=57 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=93 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in FOSI Total Score at Cycle 5	-0.223 Scores on a scale Standard Deviation 3.530	0.659 Scores on a scale Standard Deviation 3.380

OTHER_PRE_SPECIFIED outcome

Timeframe: At End of treatment (up to Cycle 33, 4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=76 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=76 Participants Participants received 2 matching placebo tablets per oral twice daily
FOSI Total Score at End of Treatment	25.011 Scores on a scale Standard Deviation 3.832	24.528 Scores on a scale Standard Deviation 3.579

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment

The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=76 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=76 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in FOSI Total Score at End of Treatment	-0.733 Scores on a scale Standard Deviation 4.089	-1.088 Scores on a scale Standard Deviation 4.067

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 1 (4 weeks per Cycle)/baseline

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=104 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=116 Participants Participants received 2 matching placebo tablets per oral twice daily
EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline	0.804 Scores on a scale Standard Deviation 0.168	0.779 Scores on a scale Standard Deviation 0.218

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 3 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=72 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=110 Participants Participants received 2 matching placebo tablets per oral twice daily
EQ-5D Index Score at Cycle 3	0.727 Scores on a scale Standard Deviation 0.219	0.767 Scores on a scale Standard Deviation 0.232

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 3 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=72 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=110 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in EQ-5D Index Score at Cycle 3	-0.068 Scores on a scale Standard Deviation 0.225	-0.003 Scores on a scale Standard Deviation 0.201

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 5 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=60 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=95 Participants Participants received 2 matching placebo tablets per oral twice daily
EQ-5D Index Score at Cycle 5	0.744 Scores on a scale Standard Deviation 0.217	0.813 Scores on a scale Standard Deviation 0.159

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 5 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=60 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=95 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in EQ-5D Index Score at Cycle 5	-0.045 Scores on a scale Standard Deviation 0.222	0.016 Scores on a scale Standard Deviation 0.180

OTHER_PRE_SPECIFIED outcome

Timeframe: At End of treatment (up to Cycle 33, 4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=76 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=72 Participants Participants received 2 matching placebo tablets per oral twice daily
EQ-5D Index Score at End of Treatment	0.731 Scores on a scale Standard Deviation 0.235	0.741 Scores on a scale Standard Deviation 0.250

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=76 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=72 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in EQ-5D Index Score at End of Treatment	-0.064 Scores on a scale Standard Deviation 0.243	-0.054 Scores on a scale Standard Deviation 0.274

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 1 (4 weeks per Cycle)/baseline

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment

The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=102 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=114 Participants Participants received 2 matching placebo tablets per oral twice daily
EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline	75.235 Scores on a scale Standard Deviation 14.494	75.868 Scores on a scale Standard Deviation 16.725

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 3 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=71 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=109 Participants Participants received 2 matching placebo tablets per oral twice daily
EQ-5D VAS Score at Cycle 3	73.042 Scores on a scale Standard Deviation 14.701	77.899 Scores on a scale Standard Deviation 16.503

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 3 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3

The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=71 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=109 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in EQ-5D VAS Score at Cycle 3	-2.225 Scores on a scale Standard Deviation 15.594	2.688 Scores on a scale Standard Deviation 10.736

OTHER_PRE_SPECIFIED outcome

Timeframe: At Cycle 5 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=57 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=94 Participants Participants received 2 matching placebo tablets per oral twice daily
EQ-5D VAS Score at Cycle 5	75.404 Scores on a scale Standard Deviation 14.177	79.915 Scores on a scale Standard Deviation 16.339

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Cycle 5 (4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5

The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=57 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=94 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in EQ-5D VAS Score at Cycle 5	-0.947 Scores on a scale Standard Deviation 15.901	3.543 Scores on a scale Standard Deviation 14.151

OTHER_PRE_SPECIFIED outcome

Timeframe: At End of treatment (up to Cycle 33, 4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=75 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=69 Participants Participants received 2 matching placebo tablets per oral twice daily
EQ-5D VAS Score at End of Treatment	71.413 Scores on a scale Standard Deviation 16.686	76.246 Scores on a scale Standard Deviation 16.017

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)

Population: PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment

The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).

Outcome measures

Outcome measures
Measure	Sorafenib (Nexavar, BAY43-9006) n=75 Participants Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=69 Participants Participants received 2 matching placebo tablets per oral twice daily
Change From Baseline in EQ-5D VAS Score at End of Treatment	-2.147 Scores on a scale Standard Deviation 18.054	0.348 Scores on a scale Standard Deviation 17.481

Adverse Events

Sorafenib (Nexavar, BAY43-9006)

Serious events: 26 serious events

Other events: 121 other events

Deaths: 0 deaths

Placebo

Serious events: 25 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events

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

Serious adverse events
Measure	Sorafenib (Nexavar, BAY43-9006) n=123 participants at risk Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=123 participants at risk Participants received 2 matching placebo tablets per oral twice daily
Blood and lymphatic system disorders Neutrophils	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Blood and lymphatic system disorders Hemoglobin	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Blood and lymphatic system disorders Lymphatics - Other	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Cardiac disorders SupraVentricular arrhythmia, Atrial fibrillation	1.6% 2/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Cardiac disorders Hypertension	1.6% 2/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Constipation	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Diarrhea	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Enteritis	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Fistula, GI, Colon/Cecum/Appendix	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Mucositis (functional/symptomatic), Esophagus	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Ileus	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Obstruction, GI, Ileum	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Obstruction, GI, Small bowel NOS	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	2.4% 3/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Vomiting	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Fever	1.6% 2/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Back	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Chest/thorax NOS	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Abdomen NOS	1.6% 2/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Head/headache	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Other (Specify)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Kidney	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Syndromes - Other	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders No Code In CTCAE	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	4.9% 6/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Hepatobiliary disorders Cholecystitis	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Hepatobiliary disorders Liver dysfunction	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Immune system disorders Allergic reaction	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Immune system disorders Allergy - Other	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Infections and infestations Infection (Documented clinically), Urinary tract NOS	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Infections and infestations Infection with normal ANC, Urinary tract NOS	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Injury, poisoning and procedural complications Intraop injury - Other	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Fracture	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	3.3% 4/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy (possibly related to cancer treatment)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Nervous system disorders Mood Alteration, Anxiety	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Nervous system disorders Neurology - Other	1.6% 2/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Nervous system disorders Syncope (fainting)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Renal and urinary disorders Fistula, GU, Vagina	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Respiratory, thoracic and mediastinal disorders Pulmonary - Other	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Hand-foot skin reaction	2.4% 3/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Wound complication, non-infectious	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Skin and subcutaneous tissue disorders Dermatology - Other	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)

Other adverse events
Measure	Sorafenib (Nexavar, BAY43-9006) n=123 participants at risk Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)	Placebo n=123 participants at risk Participants received 2 matching placebo tablets per oral twice daily
Blood and lymphatic system disorders Neutrophils	9.8% 12/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	6.5% 8/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Blood and lymphatic system disorders Platelets	7.3% 9/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.00% 0/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Blood and lymphatic system disorders Leukocytes	8.1% 10/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	2.4% 3/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Blood and lymphatic system disorders Edema: Limb	3.3% 4/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	11.4% 14/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Cardiac disorders Hypertension	36.6% 45/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	6.5% 8/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Ear and labyrinth disorders Tinnitus	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Anorexia	16.3% 20/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	4.1% 5/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Constipation	19.5% 24/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	14.6% 18/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Diarrhea	39.0% 48/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	17.9% 22/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Gastritis	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	4.9% 6/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Heartburn	4.9% 6/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	7.3% 9/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Mucositis (functional/symptomatic), Oral cavity	20.3% 25/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Nausea	26.8% 33/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	21.1% 26/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders GI - Other	6.5% 8/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	8.1% 10/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Gastrointestinal disorders Vomiting	17.9% 22/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	13.8% 17/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Fever	8.9% 11/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	8.1% 10/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Insomnia	6.5% 8/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	6.5% 8/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Fatigue	30.9% 38/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	22.8% 28/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Back	8.1% 10/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	13.0% 16/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Extremity - limb	8.9% 11/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	12.2% 15/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Abdomen NOS	17.1% 21/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	16.3% 20/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Head/headache	23.6% 29/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	15.4% 19/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Joint	10.6% 13/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	13.8% 17/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Muscle	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	7.3% 9/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Other (Specify)	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	8.9% 11/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Pain NOS	8.1% 10/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	4.1% 5/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Stomach	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	6.5% 8/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Pain, Throat/pharynx/larynx	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	1.6% 2/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
General disorders Flu-like syndrome	8.9% 11/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	13.0% 16/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Immune system disorders Allergic reaction	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	2.4% 3/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Infections and infestations Infection (Documented clinically), Upper airway NOS	4.1% 5/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Infections and infestations Infection - Other	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	2.4% 3/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Infections and infestations Infection with unknown ANC, Upper airway NOS	3.3% 4/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Metabolism and nutrition disorders ALT	10.6% 13/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	4.9% 6/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Metabolism and nutrition disorders AST	9.8% 12/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Metabolism and nutrition disorders Hypokalemia	5.7% 7/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Metabolism and nutrition disorders Hypophosphatemia	6.5% 8/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	0.81% 1/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Metabolism and nutrition disorders Metabolic/Lab - Other	7.3% 9/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	3.3% 4/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Musculoskeletal and connective tissue disorders Musculoskeletal - Other	8.1% 10/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	7.3% 9/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)
Nervous system disorders Dizziness	7.3% 9/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)	4.9% 6/123 • From the start of treatment up to 30 days after last study drug administration. Acronyms used: Gastrointestinal (GI), Genitourinary (GU), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Common Terminology Criteria for Adverse Events (CTCAE)