Sorafenib Long Term Extension Program

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00625378

Acronym

STEP

Enrollment

206

Registered

2008-02-28

Start date

2007-12-21

Completion date

2021-09-24

Last updated

2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Cancer, Sorafenib, Extension program

Brief summary

The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib. An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

At the same dose and schedule as in the participants' original clinical trials

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients, who are participating in a previous Bayer/Onyx sponsored study that has reached its endpoint (statistical and regulatory or study end), and who are, in the opinion of the Investigator, expected to continue to have an overall positive benefit/risk from continuing treatment. * Patients who have signed informed consent for this long term extension program. * Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing. The investigator should advise the patient how to achieve an adequate contraception. * Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of sorafenib in this long term extension program. * Patient is receiving sorafenib (Nexavar) as a monotherapy in their originating protocol. Patients who were being treated with sorafenib (Nexavar) in combination with other chemotherapies in the original study, but continued on single agent sorafenib (Nexavar) after discontinuation of the combination agent will be eligible. * Patient who are receiving concurrent combination with sorafenib (Nexavar) and TACE (transarterial chemoembolization) in their originating study will be eligible. * Patients who are receiving concurrent combination with sorafenib (Nexavar) and capecitabine in their originating Study 12444 (RESILIENCE) will be eligible. * Patients who are receiving concurrent combination with sorafenib (Nexavar) and erlotinib in their originating study 12917 (SEARCH) were eligible. * Patients who have completed the End of Treatment assessments in their originating study. Every effort should be made to conduct the End of Treatment visit such that the patient does not have any interruption of sorafenib dosing.

Exclusion criteria

* Any condition that is unstable or that could jeopardize the safety of the patient (please refer to the Investigator Brochure and product labeling safety sections). * History of cardiac disease: congestive heart failure \> New York Heart Association (NYHA) Class 2 or uncontrolled hypertension. * Myocardial infarction (MI) within the last 3 months. * Symptomatic metastatic brain or meningeal tumors . * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors ( Ta, Tis &T1) or any cancer curatively treated \> 5 years prior to study entry. * Patients with seizure disorder requiring medication (such as steroid anti-epileptics). * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. * Any condition which could jeopardise the safety of the patient and his/her compliance in the study. Excluded therapies and medications, previous and concomitant: * Concurrent anti-cancer chemotherapy, except transarterial chemoembolization (TACE) and capecitabine * Concurrent immunotherapy (including monoclonal antibodies), during or within 30 days prior to start of study drug * Concurrent hormonal therapy, except for bisphosphonates,during or within 30 days prior to start of study drug * Concomitant Rifampicin and St John's Wort (Warfarin may be used only with very close monitoring) * Radiotherapy during study or within 3 weeks of start of study drug. \[Palliative radiotherapy will be allowed\] * Concomitant use of potent inhibitors of CYP3A4 including ketoconazole, itraconazole and ritonavir. Consumption of grapefruit juice should also be avoided.

Design outcomes

Primary

Measure	Time frame	Description
Sorafenib Treatment Duration Within STEP	From the date of the first sorafenib dose until the date of the last sorafenib dose, with a mean duration of 25 months and max duraton of 153.8 months	Treatment duration was calculated in days as the date of the last dose of any study treatment minus date of the first dose of any study treatment plus one day.
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	From signing the informed consent form (ICF) in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The adverse event did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly or birth defect; was an important medical event. A new treatment-emergent adverse event (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. A drug-related new TEAE was any new TEAE that had a causal relationship with the study treatment as assessed by the investigator.
Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A new treatment-emergent adverse event (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A new treatment-emergent AE (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. A drug-related new TEAE was a new TEAE that had a causal relationship with the study treatment as assessed by the investigator. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria (CTC v3). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. The general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
Number of Participants With All Adverse Events	From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A drug-related AE was any AE that had a causal relationship with the study treatment as assessed by the investigator. All AEs in STEP were the combination of AEs ongoing from feeder studies and new TEAEs.
Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade	From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. All AEs in STEP were the combination of AEs ongoing from feeder studies and new TEAEs. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE	From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months	An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A drug-related AE was any AE that had a causal relationship with the study treatment as assessed by the investigator. All AEs in STEP was a combination of AEs ongoing from feeder studies and new TEAEs. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
Number of Deaths With Primary Cause of Death	From signing the ICF in STEP until completion or discontinuation of the study, with a mean duration of 26 months	Primary cause of death included: any cause; progressive disease; toxicity due to study treatment (with at least one AE with outcome death); other (unspecified) or missing cause.
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months	Hematology and blood chemistry values were summarized according to their worst CTCAE grade, where applicable. Hematology and blood chemistry values were graded based on the applicable laboratory threshold values outlined in NCI CTCAE version 3.0. Participants with a specific laboratory value that were not graded are not included in the table. CTCAE grade was set to not graded if the reference ranges or other information necessary to derive grades were unavailable or result had a special character (such as \> or \< ). The Common Terminology Criteria for Adverse Events (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.
Number of Participants With ECOG Performance Status by 6-months Time Intervals	Up to 156 months	Eastern cooperative oncology group (ECOG) performance status: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5 = Dead

Countries

Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, France, Germany, Hong Kong, Italy, New Zealand, Poland, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States

Participant flow

Recruitment details

The study was conducted at multiple centers in 19 countries between 21-Dec-2007 (first participant first visit) and 24-Sep-2021 (last participant last visit).

Pre-assignment details

Overall, 206 participants were transferred from the feeder studies and have signed informed consent for STEP. Of these 206 participants, 2 participants were never treated and 204 participants received the study treatment.

Participants by arm

Arm	Count
Sorafenib Monotherapy Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.	203
Sorafenib+Erlotinib Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.	1
Total	204

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	22	0
Overall Study	Death	38	0
Overall Study	Disease progression, recurrence or relapse	88	0
Overall Study	End of treatment not available	2	0
Overall Study	Investigator's judgement (no need to continue treatment)	1	0
Overall Study	Lost to Follow-up	17	0
Overall Study	Medical decision	1	0
Overall Study	Missing	2	0
Overall Study	Multiple toxicities	1	0
Overall Study	Never treated	2	0
Overall Study	New cancer	1	0
Overall Study	Non-compliant with study medication	3	0
Overall Study	PTA program	2	0
Overall Study	Recurrent rise in amylase and lipase	1	0
Overall Study	Sponsor decision	1	0
Overall Study	Sponsor's decision to stop the trial	1	0
Overall Study	Switch to commercial drug	6	1
Overall Study	Withdrawal by Subject	16	0

Baseline characteristics

Characteristic	Sorafenib Monotherapy	Sorafenib+Erlotinib	Total
Age, Continuous	63.5 years STANDARD_DEVIATION 9.6	20.0 years	63.3 years STANDARD_DEVIATION 10.1
ECOG performance status ECOG 0	25 Participants	1 Participants	26 Participants
ECOG performance status ECOG 1	16 Participants	0 Participants	16 Participants
ECOG performance status ECOG 2	1 Participants	0 Participants	1 Participants
ECOG performance status Missing	161 Participants	0 Participants	161 Participants
Race/Ethnicity, Customized Asian	39 Participants	1 Participants	40 Participants
Race/Ethnicity, Customized Hispanic	2 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Japanese/American	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White	161 Participants	0 Participants	161 Participants
Sex: Female, Male Female	63 Participants	0 Participants	63 Participants
Sex: Female, Male Male	140 Participants	1 Participants	141 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	62 / 203	0 / 1
other Total, other adverse events	151 / 203	1 / 1
serious Total, serious adverse events	114 / 203	1 / 1

Outcome results

Primary

Number of Deaths With Primary Cause of Death

Primary cause of death included: any cause; progressive disease; toxicity due to study treatment (with at least one AE with outcome death); other (unspecified) or missing cause.

Time frame: From signing the ICF in STEP until completion or discontinuation of the study, with a mean duration of 26 months

Population: Safety analysis set (SAF)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Deaths With Primary Cause of Death	Progressive disease	34 Participants
Sorafenib Monotherapy	Number of Deaths With Primary Cause of Death	Other	21 Participants
Sorafenib Monotherapy	Number of Deaths With Primary Cause of Death	Toxicity due to study treatment	3 Participants
Sorafenib Monotherapy	Number of Deaths With Primary Cause of Death	Missing	4 Participants
Sorafenib Monotherapy	Number of Deaths With Primary Cause of Death	Any cause	62 Participants
Sorafenib+Erlotinib	Number of Deaths With Primary Cause of Death	Missing	0 Participants
Sorafenib+Erlotinib	Number of Deaths With Primary Cause of Death	Any cause	0 Participants
Sorafenib+Erlotinib	Number of Deaths With Primary Cause of Death	Progressive disease	0 Participants
Sorafenib+Erlotinib	Number of Deaths With Primary Cause of Death	Toxicity due to study treatment	0 Participants
Sorafenib+Erlotinib	Number of Deaths With Primary Cause of Death	Other	0 Participants

Primary

Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade

Hematology and blood chemistry values were summarized according to their worst CTCAE grade, where applicable. Hematology and blood chemistry values were graded based on the applicable laboratory threshold values outlined in NCI CTCAE version 3.0. Participants with a specific laboratory value that were not graded are not included in the table. CTCAE grade was set to not graded if the reference ranges or other information necessary to derive grades were unavailable or result had a special character (such as \> or \< ). The Common Terminology Criteria for Adverse Events (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.

Time frame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

Population: Participants in safety analysis set (SAF) with evaluable data for each evaluated laboratory parameter

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Hemoglobin - Grade 3	13 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Leukocytes - Grade 3	2 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	INR - Grade 1	17 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	INR - Grade 2	1 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	INR - Grade 3	11 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	INR - Grade 4	0 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	ALT - Grade 1	66 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	ALT - Grade 3	7 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	ALT - Grade 4	0 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Amylase - Grade 1	39 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Amylase - Grade 2	12 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Amylase - Grade 3	8 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Amylase - Grade 4	0 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	AST - Grade 4	0 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lipase - Grade 1	32 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lipase - Grade 4	7 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lymphopenia - Grade 2	37 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lymphopenia - Grade 3	20 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lymphopenia - Grade 4	4 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Platelets - Grade 3	7 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Leukocytes - Grade 4	1 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	ALT - Grade 2	13 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	AST - Grade 1	88 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	AST - Grade 2	19 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	AST - Grade 3	6 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lipase - Grade 2	11 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lipase - Grade 3	28 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Neutrophils - Grade 1	19 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Neutrophils - Grade 2	7 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Neutrophils - Grade 3	0 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Neutrophils - Grade 4	2 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Hemoglobin - Grade 1	67 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Hemoglobin - Grade 2	40 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Hemoglobin - Grade 4	8 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lymphopenia - Grade 1	37 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Platelets - Grade 1	48 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Platelets - Grade 2	7 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Platelets - Grade 4	17 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Leukocytes - Grade 1	40 Participants
Sorafenib Monotherapy	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Leukocytes - Grade 2	12 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Hemoglobin - Grade 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Amylase - Grade 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Hemoglobin - Grade 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Amylase - Grade 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lymphopenia - Grade 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lymphopenia - Grade 4	1 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lipase - Grade 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lipase - Grade 2	1 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lipase - Grade 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lymphopenia - Grade 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Leukocytes - Grade 1	1 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	AST - Grade 1	1 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Leukocytes - Grade 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lymphopenia - Grade 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Hemoglobin - Grade 1	1 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Lipase - Grade 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Platelets - Grade 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Platelets - Grade 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	AST - Grade 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	ALT - Grade 1	1 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	ALT - Grade 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Platelets - Grade 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	ALT - Grade 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Platelets - Grade 4	1 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	ALT - Grade 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Leukocytes - Grade 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Amylase - Grade 1	1 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	AST - Grade 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Leukocytes - Grade 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Amylase - Grade 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	Hemoglobin - Grade 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade	AST - Grade 2	0 Participants

Primary

Number of Participants With All Adverse Events

Time frame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

Population: Safety analysis set (SAF)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Participants With All Adverse Events	Any AE	184 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	Serious AE (SAE)	114 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	AE leading to dose modification	72 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	AE leading to study drug discontinuation	56 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	AE leading to death	37 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	Sorafenib-related AE	159 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	Sorafenib-related SAE	26 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	Sorafenib-related AE leading to dose modification	53 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	Sorafenib-related AE leading to study drug discontinuation	21 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events	Sorafenib-related AE leading to death	2 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	Sorafenib-related AE leading to dose modification	0 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	Any AE	1 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	Sorafenib-related AE	1 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	Serious AE (SAE)	1 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	Sorafenib-related AE leading to death	0 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	AE leading to dose modification	0 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	Sorafenib-related SAE	1 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	AE leading to study drug discontinuation	0 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	Sorafenib-related AE leading to study drug discontinuation	0 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events	AE leading to death	0 Participants

Primary

Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. All AEs in STEP were the combination of AEs ongoing from feeder studies and new TEAEs. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.

Time frame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

Population: Safety analysis set (SAF)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 3	81 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 4	17 Participants
Sorafenib Monotherapy	Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 5	37 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 3	1 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 4	1 Participants
Sorafenib+Erlotinib	Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 5	0 Participants

Primary

Number of Participants With ECOG Performance Status by 6-months Time Intervals

Eastern cooperative oncology group (ECOG) performance status: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5 = Dead

Time frame: Up to 156 months

Population: Participants in safety analysis set (SAF) with evaluable data for the evaluation at each timepoint

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 0	7 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 0	28 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 1	11 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	Missing	3 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 0	29 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	Missing	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	Missing	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 0	22 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 1	7 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 3	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	Missing	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 0	15 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 1	9 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 5	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	Missing	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 0	13 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 1	7 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 0	9 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 1	8 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 5	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 0	10 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 1	8 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 0	9 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 1	6 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 5	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	Missing	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 1	6 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	Missing	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 1	6 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 0	8 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 1	6 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 0	8 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 0	7 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 0	6 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 1	5 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 0	5 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 1	4 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	Missing	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 0	4 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	Missing	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 0	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 1	3 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 0	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 1	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 0	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 1	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 0	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 1	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 0	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 1	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 0	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 1	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 0	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 1	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 0	20 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 1	25 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 2	4 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 5	5 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 1	6 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 2	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 5	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 5	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 0	11 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	Missing	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 2	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 1	6 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 1	5 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 1	4 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 0	4 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 1	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 1	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 5	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	Missing	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 0	2 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 1	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 0	1 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 3	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 4	0 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	Missing	9 Participants
Sorafenib Monotherapy	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 3	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 0	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 0	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 0	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 0	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 19-24	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 0	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 0	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 0	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 37-42	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 127-132	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 49-54	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 1-6	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 7-12	ECOG 0	1 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 109-114	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 13-18	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 61-66	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 133-138	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 25-30	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 67-72	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 121-126	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 73-78	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 31-36	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 79-84	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 139-144	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Last available value	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 43-48	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 85-90	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 1	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 115-120	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 91-96	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 0	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 3	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 55-60	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 97-102	ECOG 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 145-150	ECOG 2	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 103-108	Missing	0 Participants
Sorafenib+Erlotinib	Number of Participants With ECOG Performance Status by 6-months Time Intervals	Months 151-156	ECOG 0	0 Participants

Primary

Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A new treatment-emergent adverse event (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.

Time frame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

Population: Safety analysis set (SAF)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 3	71 Participants
Sorafenib Monotherapy	Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 5	37 Participants
Sorafenib Monotherapy	Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 4	17 Participants
Sorafenib+Erlotinib	Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 3	1 Participants
Sorafenib+Erlotinib	Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 4	1 Participants
Sorafenib+Erlotinib	Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 5	0 Participants

Primary

Number of Participants With New Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The adverse event did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly or birth defect; was an important medical event. A new treatment-emergent adverse event (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. A drug-related new TEAE was any new TEAE that had a causal relationship with the study treatment as assessed by the investigator.

Time frame: From signing the informed consent form (ICF) in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

Population: Safety analysis set (SAF)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Any AE	166 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Serious AE (SAE)	113 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	AE leading to study drug discontinuation	56 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	AE leading to death	37 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related AE	117 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related SAE	25 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related AE leading to dose modification	42 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related AE leading to study drug discontinuation	21 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related AE leading to death	2 Participants
Sorafenib Monotherapy	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	AE leading to dose modification	64 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	AE leading to death	0 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Any AE	1 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related AE leading to dose modification	0 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Serious AE (SAE)	1 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	AE leading to dose modification	0 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related AE leading to study drug discontinuation	0 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	AE leading to study drug discontinuation	0 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related AE	1 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related AE leading to death	0 Participants
Sorafenib+Erlotinib	Number of Participants With New Treatment-emergent Adverse Events (TEAEs)	Sorafenib-related SAE	1 Participants

Primary

Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A drug-related AE was any AE that had a causal relationship with the study treatment as assessed by the investigator. All AEs in STEP was a combination of AEs ongoing from feeder studies and new TEAEs. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria, Version 3.0 (NCI-CTC v. 3.0). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.

Time frame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

Population: Safety analysis set (SAF)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE	Grade 5	2 Participants
Sorafenib Monotherapy	Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE	Grade 3	65 Participants
Sorafenib Monotherapy	Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE	Grade 4	6 Participants
Sorafenib+Erlotinib	Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE	Grade 4	0 Participants
Sorafenib+Erlotinib	Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE	Grade 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE	Grade 3	1 Participants

Primary

Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product. The AE did not necessarily have to have a causal relationship with this treatment. A new treatment-emergent AE (TEAE) was any AE that had a start date on or after ICF date in STEP and up to 30 days after the last sorafenib dose. A drug-related new TEAE was a new TEAE that had a causal relationship with the study treatment as assessed by the investigator. The intensity or severity of AEs were graded using the National Cancer Institute-Common Terminology Criteria (CTC v3). The Common Terminology Criteria for AE (CTCAE) are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. It uses a range of grades from 1 to 5. The general guideline is: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe; Grade 4 - life-threatening; Grade 5 - death.

Time frame: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months

Population: Safety analysis set (SAF)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Sorafenib Monotherapy	Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 3	49 Participants
Sorafenib Monotherapy	Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 5	2 Participants
Sorafenib Monotherapy	Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 4	6 Participants
Sorafenib+Erlotinib	Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 3	1 Participants
Sorafenib+Erlotinib	Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 5	0 Participants
Sorafenib+Erlotinib	Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade	Grade 4	0 Participants

Primary

Sorafenib Treatment Duration Within STEP

Treatment duration was calculated in days as the date of the last dose of any study treatment minus date of the first dose of any study treatment plus one day.

Time frame: From the date of the first sorafenib dose until the date of the last sorafenib dose, with a mean duration of 25 months and max duraton of 153.8 months

Population: Safety analysis set (SAF)

Arm	Measure	Value (MEDIAN)
Sorafenib Monotherapy	Sorafenib Treatment Duration Within STEP	15.69 Months
Sorafenib+Erlotinib	Sorafenib Treatment Duration Within STEP	40.13 Months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Sorafenib Long Term Extension Program

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Number of Deaths With Primary Cause of Death

Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade

Number of Participants With All Adverse Events

Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade

Number of Participants With ECOG Performance Status by 6-months Time Intervals

Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade

Number of Participants With New Treatment-emergent Adverse Events (TEAEs)

Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE

Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade

Sorafenib Treatment Duration Within STEP