Trial Outcomes & Findings for Sorafenib Long Term Extension Program (NCT NCT00625378)
NCT ID: NCT00625378
Last Updated: 2022-09-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
206 participants
Primary outcome timeframe
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
Results posted on
2022-09-01
Participant Flow
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).
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.
Participant milestones
| Measure |
Sorafenib Monotherapy
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
1
|
|
Overall Study
Treated in STEP
|
203
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
205
|
1
|
Reasons for withdrawal
| Measure |
Sorafenib Monotherapy
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Overall Study
Adverse Event
|
22
|
0
|
|
Overall Study
Withdrawal by Subject
|
16
|
0
|
|
Overall Study
Death
|
38
|
0
|
|
Overall Study
Disease progression, recurrence or relapse
|
88
|
0
|
|
Overall Study
Lost to Follow-up
|
17
|
0
|
|
Overall Study
Non-compliant with study medication
|
3
|
0
|
|
Overall Study
Investigator's judgement (no need to continue treatment)
|
1
|
0
|
|
Overall Study
Medical decision
|
1
|
0
|
|
Overall Study
Multiple toxicities
|
1
|
0
|
|
Overall Study
New cancer
|
1
|
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
Missing
|
2
|
0
|
|
Overall Study
End of treatment not available
|
2
|
0
|
|
Overall Study
Never treated
|
2
|
0
|
Baseline Characteristics
Sorafenib Long Term Extension Program
Baseline characteristics by cohort
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
ECOG performance status
ECOG 2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ECOG performance status
Missing
|
161 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
20.0 years
STANDARD_DEVIATION NA • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese/American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
161 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
ECOG performance status
ECOG 0
|
25 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
ECOG performance status
ECOG 1
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 monthsPopulation: Safety analysis set (SAF)
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Sorafenib Treatment Duration Within STEP
|
15.69 Months
Interval 6.41 to 33.19
|
40.13 Months
Interval 40.13 to 40.13
|
PRIMARY outcome
Timeframe: From signing the informed consent form (ICF) in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 monthsPopulation: Safety analysis set (SAF)
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
Serious AE (SAE)
|
113 Participants
|
1 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
AE leading to dose modification
|
64 Participants
|
0 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
Sorafenib-related AE leading to study drug discontinuation
|
21 Participants
|
0 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
AE leading to study drug discontinuation
|
56 Participants
|
0 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
AE leading to death
|
37 Participants
|
0 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
Sorafenib-related AE
|
117 Participants
|
1 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
Sorafenib-related SAE
|
25 Participants
|
1 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
Sorafenib-related AE leading to death
|
2 Participants
|
0 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
Sorafenib-related AE leading to dose modification
|
42 Participants
|
0 Participants
|
|
Number of Participants With New Treatment-emergent Adverse Events (TEAEs)
Any AE
|
166 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 monthsPopulation: Safety analysis set (SAF)
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 3
|
71 Participants
|
1 Participants
|
|
Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 4
|
17 Participants
|
1 Participants
|
|
Number of Participants With New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 5
|
37 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 monthsPopulation: Safety analysis set (SAF)
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 3
|
49 Participants
|
1 Participants
|
|
Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 4
|
6 Participants
|
0 Participants
|
|
Number of Participants With Study Drug-related New TEAEs of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 5
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 monthsPopulation: Safety analysis set (SAF)
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Participants With All Adverse Events
Any AE
|
184 Participants
|
1 Participants
|
|
Number of Participants With All Adverse Events
Serious AE (SAE)
|
114 Participants
|
1 Participants
|
|
Number of Participants With All Adverse Events
AE leading to dose modification
|
72 Participants
|
0 Participants
|
|
Number of Participants With All Adverse Events
AE leading to study drug discontinuation
|
56 Participants
|
0 Participants
|
|
Number of Participants With All Adverse Events
AE leading to death
|
37 Participants
|
0 Participants
|
|
Number of Participants With All Adverse Events
Sorafenib-related AE
|
159 Participants
|
1 Participants
|
|
Number of Participants With All Adverse Events
Sorafenib-related SAE
|
26 Participants
|
1 Participants
|
|
Number of Participants With All Adverse Events
Sorafenib-related AE leading to dose modification
|
53 Participants
|
0 Participants
|
|
Number of Participants With All Adverse Events
Sorafenib-related AE leading to study drug discontinuation
|
21 Participants
|
0 Participants
|
|
Number of Participants With All Adverse Events
Sorafenib-related AE leading to death
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 monthsPopulation: Safety analysis set (SAF)
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 3
|
81 Participants
|
1 Participants
|
|
Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 4
|
17 Participants
|
1 Participants
|
|
Number of Participants With All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE Grade
Grade 5
|
37 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 monthsPopulation: Safety analysis set (SAF)
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE
Grade 3
|
65 Participants
|
1 Participants
|
|
Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE
Grade 4
|
6 Participants
|
0 Participants
|
|
Number of Participants With Study Drug-related All Adverse Events of CTCAE Grades 3 or Higher by Worst CTCAE
Grade 5
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the ICF in STEP until completion or discontinuation of the study, with a mean duration of 26 monthsPopulation: Safety analysis set (SAF)
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Deaths With Primary Cause of Death
Any cause
|
62 Participants
|
0 Participants
|
|
Number of Deaths With Primary Cause of Death
Progressive disease
|
34 Participants
|
0 Participants
|
|
Number of Deaths With Primary Cause of Death
Toxicity due to study treatment
|
3 Participants
|
0 Participants
|
|
Number of Deaths With Primary Cause of Death
Other
|
21 Participants
|
0 Participants
|
|
Number of Deaths With Primary Cause of Death
Missing
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 monthsPopulation: Participants in safety analysis set (SAF) with evaluable data for each evaluated laboratory parameter
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.
Outcome measures
| Measure |
Sorafenib Monotherapy
n=203 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Neutrophils - Grade 1
|
19 Participants
|
—
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Neutrophils - Grade 2
|
7 Participants
|
—
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Neutrophils - Grade 3
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Neutrophils - Grade 4
|
2 Participants
|
—
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Hemoglobin - Grade 1
|
67 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Hemoglobin - Grade 2
|
40 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Hemoglobin - Grade 3
|
13 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Hemoglobin - Grade 4
|
8 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Lymphopenia - Grade 1
|
37 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Lymphopenia - Grade 2
|
37 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Lymphopenia - Grade 3
|
20 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Lymphopenia - Grade 4
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Platelets - Grade 1
|
48 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Platelets - Grade 2
|
7 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Platelets - Grade 3
|
7 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Platelets - Grade 4
|
17 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Leukocytes - Grade 1
|
40 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Leukocytes - Grade 2
|
12 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Leukocytes - Grade 3
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Leukocytes - Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
INR - Grade 1
|
17 Participants
|
—
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
INR - Grade 2
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
INR - Grade 3
|
11 Participants
|
—
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
INR - Grade 4
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
ALT - Grade 1
|
66 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
ALT - Grade 2
|
13 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
ALT - Grade 3
|
7 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
ALT - Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Amylase - Grade 1
|
39 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Amylase - Grade 2
|
12 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Amylase - Grade 3
|
8 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Amylase - Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
AST - Grade 1
|
88 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
AST - Grade 2
|
19 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
AST - Grade 3
|
6 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
AST - Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Lipase - Grade 1
|
32 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Lipase - Grade 2
|
11 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Lipase - Grade 3
|
28 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematological and Biochemical Laboratory Values by Worst CTCAE Grade
Lipase - Grade 4
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 156 monthsPopulation: Participants in safety analysis set (SAF) with evaluable data for the evaluation at each timepoint
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
Outcome measures
| Measure |
Sorafenib Monotherapy
n=64 Participants
Participants received single-agent sorafenib at the same dose and schedule as in their original Clinical Trial.
|
Sorafenib+Erlotinib
n=1 Participants
Participants received sorafenib and erlotinib combination at the same dose and schedule as in their original Clinical Trial.
|
|---|---|---|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 1-6 · Missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 1-6 · ECOG 0
|
28 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 1-6 · ECOG 1
|
11 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 1-6 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 1-6 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 1-6 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 1-6 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 7-12 · Missing
|
3 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 7-12 · ECOG 0
|
29 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 7-12 · ECOG 1
|
6 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 7-12 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 7-12 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 7-12 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 7-12 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 13-18 · Missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 13-18 · ECOG 0
|
22 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 13-18 · ECOG 1
|
7 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 13-18 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 13-18 · ECOG 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 13-18 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 13-18 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 19-24 · Missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 19-24 · ECOG 0
|
15 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 19-24 · ECOG 1
|
9 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 19-24 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 19-24 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 19-24 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 19-24 · ECOG 5
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 25-30 · Missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 25-30 · ECOG 0
|
13 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 25-30 · ECOG 1
|
7 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 25-30 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 25-30 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 25-30 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 25-30 · ECOG 5
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 31-36 · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 31-36 · ECOG 0
|
9 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 31-36 · ECOG 1
|
8 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 31-36 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 31-36 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 31-36 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 31-36 · ECOG 5
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 37-42 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 37-42 · ECOG 0
|
10 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 37-42 · ECOG 1
|
8 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 37-42 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 37-42 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 37-42 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 37-42 · ECOG 5
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 43-48 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 43-48 · ECOG 0
|
9 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 43-48 · ECOG 1
|
6 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 43-48 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 43-48 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 43-48 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 43-48 · ECOG 5
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 49-54 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 49-54 · ECOG 0
|
7 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 49-54 · ECOG 1
|
6 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 49-54 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 49-54 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 49-54 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 49-54 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 55-60 · Missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 55-60 · ECOG 0
|
11 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 55-60 · ECOG 1
|
6 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 55-60 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 55-60 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 55-60 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 55-60 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 61-66 · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 61-66 · ECOG 0
|
8 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 61-66 · ECOG 1
|
6 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 61-66 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 61-66 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 61-66 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 61-66 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 67-72 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 67-72 · ECOG 0
|
8 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 67-72 · ECOG 1
|
6 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 67-72 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 67-72 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 67-72 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 67-72 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 73-78 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 73-78 · ECOG 0
|
7 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 73-78 · ECOG 1
|
5 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 73-78 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 73-78 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 73-78 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 73-78 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 79-84 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 79-84 · ECOG 0
|
6 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 79-84 · ECOG 1
|
4 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 79-84 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 79-84 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 79-84 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 79-84 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 85-90 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 85-90 · ECOG 0
|
4 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 85-90 · ECOG 1
|
5 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 85-90 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 85-90 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 85-90 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 85-90 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 91-96 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 91-96 · ECOG 0
|
5 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 91-96 · ECOG 1
|
4 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 91-96 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 91-96 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 91-96 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 91-96 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 97-102 · Missing
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 97-102 · ECOG 0
|
4 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 97-102 · ECOG 1
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 97-102 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 97-102 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 97-102 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 97-102 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 103-108 · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 103-108 · ECOG 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 103-108 · ECOG 1
|
3 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 103-108 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 103-108 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 103-108 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 103-108 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 109-114 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 109-114 · ECOG 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 109-114 · ECOG 1
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 109-114 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 109-114 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 109-114 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 109-114 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 115-120 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 115-120 · ECOG 0
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 115-120 · ECOG 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 115-120 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 115-120 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 115-120 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 115-120 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 121-126 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 121-126 · ECOG 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 121-126 · ECOG 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 121-126 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 121-126 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 121-126 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 121-126 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 127-132 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 127-132 · ECOG 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 127-132 · ECOG 1
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 127-132 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 127-132 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 127-132 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 127-132 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 133-138 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 133-138 · ECOG 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 133-138 · ECOG 1
|
2 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 133-138 · ECOG 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 133-138 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 133-138 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 133-138 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 139-144 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 139-144 · ECOG 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 139-144 · ECOG 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 139-144 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 139-144 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 139-144 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 139-144 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 145-150 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 145-150 · ECOG 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 145-150 · ECOG 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 145-150 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 145-150 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 145-150 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 145-150 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 151-156 · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 151-156 · ECOG 0
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 151-156 · ECOG 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 151-156 · ECOG 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 151-156 · ECOG 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 151-156 · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Months 151-156 · ECOG 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Last available value · Missing
|
9 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Last available value · ECOG 0
|
20 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Last available value · ECOG 1
|
25 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Last available value · ECOG 2
|
4 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Last available value · ECOG 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Last available value · ECOG 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status by 6-months Time Intervals
Last available value · ECOG 5
|
5 Participants
|
0 Participants
|
Adverse Events
Sorafenib Monotherapy
Serious events: 114 serious events
Other events: 151 other events
Deaths: 62 deaths
Sorafenib+Erlotinib
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib Monotherapy
n=203 participants at risk
Sorafenib monotherapy
|
Sorafenib+Erlotinib
n=1 participants at risk
Sorafenib+Erlotinib
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
8/203 • Number of events 10 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Angina pectoris
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Angina unstable
|
1.5%
3/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Cardiac arrest
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Cardiac failure
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Cardiac failure acute
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/203 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
100.0%
1/1 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
5/203 • Number of events 5 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Eye disorders
Retinal vein occlusion
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
4/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Ascites
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Constipation
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.99%
2/203 • Number of events 5 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.99%
2/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Gastritis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Haematemesis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Ileus
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Subileus
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
100.0%
1/1 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Asthenia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Chest pain
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Death
|
3.0%
6/203 • Number of events 6 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Disease progression
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
100.0%
1/1 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Impaired healing
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.5%
5/203 • Number of events 5 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Pyrexia
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Sudden death
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Hepatobiliary disorders
Hepatic failure
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Hepatobiliary disorders
Jaundice
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Immune system disorders
Drug hypersensitivity
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Abscess limb
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Appendicitis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/203 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
100.0%
1/1 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Clostridium difficile infection
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Diverticulitis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Ear infection
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Furuncle
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Gastroenteritis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Groin abscess
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Localised infection
|
0.99%
2/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Perirectal abscess
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Pneumonia
|
4.4%
9/203 • Number of events 10 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Pneumonia aspiration
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Sepsis
|
3.0%
6/203 • Number of events 6 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Staphylococcal infection
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Infections and infestations
Urosepsis
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Injury, poisoning and procedural complications
Neurological procedural complication
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Angiocardiogram
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Blood bilirubin increased
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Haemoglobin decreased
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
International normalised ratio increased
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.49%
1/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
2.0%
4/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.49%
1/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm recurrence
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung metastatic
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Basal ganglia infarction
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Brain oedema
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Dizziness
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Headache
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.99%
2/203 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Migraine
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Presyncope
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Seizure
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Spinal cord compression
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Psychiatric disorders
Depression
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Psychiatric disorders
Personality change
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Renal and urinary disorders
Renal failure
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
4/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
4/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Surgical and medical procedures
Stent placement
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Vascular disorders
Arterial occlusive disease
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Vascular disorders
Hypertension
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
100.0%
1/1 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Vascular disorders
Lymphoedema
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Vascular disorders
Orthostatic hypotension
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Vascular disorders
Peripheral artery occlusion
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Vascular disorders
Peripheral ischaemia
|
0.49%
1/203 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
Other adverse events
| Measure |
Sorafenib Monotherapy
n=203 participants at risk
Sorafenib monotherapy
|
Sorafenib+Erlotinib
n=1 participants at risk
Sorafenib+Erlotinib
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
15/203 • Number of events 16 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.5%
5/203 • Number of events 5 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
4/203 • Number of events 5 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
8/203 • Number of events 18 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
5/203 • Number of events 13 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Ascites
|
2.0%
4/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Constipation
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
49.3%
100/203 • Number of events 147 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
5/203 • Number of events 6 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Nausea
|
5.4%
11/203 • Number of events 14 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
12/203 • Number of events 15 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
6/203 • Number of events 10 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Asthenia
|
3.0%
6/203 • Number of events 7 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
General disorders
Fatigue
|
16.3%
33/203 • Number of events 41 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Alanine aminotransferase increased
|
3.9%
8/203 • Number of events 9 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Amylase increased
|
4.4%
9/203 • Number of events 13 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Aspartate aminotransferase increased
|
3.9%
8/203 • Number of events 10 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Haemoglobin decreased
|
3.4%
7/203 • Number of events 9 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Lipase increased
|
6.4%
13/203 • Number of events 15 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Platelet count decreased
|
3.0%
6/203 • Number of events 6 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Investigations
Weight decreased
|
4.9%
10/203 • Number of events 10 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.9%
16/203 • Number of events 16 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
5/203 • Number of events 8 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
6/203 • Number of events 10 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
5/203 • Number of events 7 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Headache
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Lethargy
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Psychiatric disorders
Insomnia
|
2.0%
4/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Renal and urinary disorders
Proteinuria
|
2.5%
5/203 • Number of events 5 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Renal and urinary disorders
Renal failure
|
2.5%
5/203 • Number of events 6 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
3/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.0%
4/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
5/203 • Number of events 5 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.99%
2/203 • Number of events 3 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
100.0%
1/1 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
11/203 • Number of events 12 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
6/203 • Number of events 6 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
40.4%
82/203 • Number of events 96 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
100.0%
1/1 • Number of events 1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
4/203 • Number of events 4 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
16/203 • Number of events 19 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Vascular disorders
Flushing
|
1.5%
3/203 • Number of events 7 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
0.00%
0/1 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
|
Vascular disorders
Hypertension
|
12.8%
26/203 • Number of events 26 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
100.0%
1/1 • Number of events 2 • From signing the ICF in STEP until 30 days after the last sorafenib dose, with a mean duration of 26 months. Reporting for the numbers of all-cause mortality considers all deaths that occurred at any time during the study until the end of the follow up (with a mean duration of 26 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI will not present or publish data until the full multi-center Trial has been reported in full. If a publication is not published within 24 \[OR: 12-THIS IS MINIMUM\] months after completion of the Trial, the PI may present or publish data.
- Publication restrictions are in place
Restriction type: OTHER