Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) (NCT NCT03555149)
NCT ID: NCT03555149
Last Updated: 2023-11-07
Results Overview
The best confirmed overall response rate (ORR) is defined as the percentage of participants with a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1. Participants could be classified as "Stable Disease" if the assessment was at least 6 weeks from randomization. Participants were classified as Missing if no post-baseline response assessments were available. Participants were classified as Not Evaluable if all post-baseline response assessments were unevaluable. The differences in ORR between the experimental arms and the corresponding control arm were calculated, along with 95% confidence intervals (CIs), using normal approximation of the binomial distribution. The 95% CIs for ORRs were constructed using the Clopper-Pearson method. The 95% CIs for the difference in rates were constructed using the Wald method with continuity correction.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
96 participants
Primary outcome timeframe
From randomization until disease progression or loss of clinical benefit (up to 4 years)
Results posted on
2023-11-07
Participant Flow
The study was conducted at 15 centers in 5 countries: United States, France, Republic of Korea, Australia, and Switzerland.
Participant milestones
| Measure |
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
15
|
15
|
6
|
4
|
15
|
15
|
2
|
|
Overall Study
Received at Least One Dose of Study Treatment
|
19
|
15
|
15
|
6
|
4
|
15
|
15
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
24
|
15
|
15
|
6
|
4
|
15
|
15
|
2
|
Reasons for withdrawal
| Measure |
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
18
|
15
|
15
|
4
|
4
|
11
|
12
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
1
|
0
|
0
|
0
|
0
|
2
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
Baseline characteristics by cohort
| Measure |
Regorafenib (Control)
n=24 Participants
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age (year)
|
59.5 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
57.8 Years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
52.3 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
66.8 Years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
56.3 Years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
56.4 Years
STANDARD_DEVIATION 8.2 • n=10 Participants
|
55.1 Years
STANDARD_DEVIATION 9.2 • n=115 Participants
|
58.0 Years
STANDARD_DEVIATION 11.3 • n=24 Participants
|
57.2 Years
STANDARD_DEVIATION 9.7 • n=42 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
51 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
76 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
55 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
ECOG score
0
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
|
ECOG score
1
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
51 Participants
n=42 Participants
|
|
Number of Metastatic Sites at Enrollment
1
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Number of Metastatic Sites at Enrollment
2
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
|
Number of Metastatic Sites at Enrollment
3
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Number of Metastatic Sites at Enrollment
>=4
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression or loss of clinical benefit (up to 4 years)Population: The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
The best confirmed overall response rate (ORR) is defined as the percentage of participants with a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1. Participants could be classified as "Stable Disease" if the assessment was at least 6 weeks from randomization. Participants were classified as Missing if no post-baseline response assessments were available. Participants were classified as Not Evaluable if all post-baseline response assessments were unevaluable. The differences in ORR between the experimental arms and the corresponding control arm were calculated, along with 95% confidence intervals (CIs), using normal approximation of the binomial distribution. The 95% CIs for ORRs were constructed using the Clopper-Pearson method. The 95% CIs for the difference in rates were constructed using the Wald method with continuity correction.
Outcome measures
| Measure |
Regorafenib (Control)
n=19 Participants
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Responders (CR + PR)
|
0 Percentage of Participants
Interval 0.0 to 17.65
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
0 Percentage of Participants
Interval 0.0 to 45.93
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
|
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Complete Response (CR)
|
0 Percentage of Participants
Interval 0.0 to 17.65
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
0 Percentage of Participants
Interval 0.0 to 45.93
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
|
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Partial Response (PR)
|
0 Percentage of Participants
Interval 0.0 to 17.65
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
0 Percentage of Participants
Interval 0.0 to 45.93
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
|
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Stable Disease (SD)
|
63.2 Percentage of Participants
Interval 38.36 to 83.71
|
33.3 Percentage of Participants
Interval 11.82 to 61.62
|
20.0 Percentage of Participants
Interval 4.33 to 48.09
|
50 Percentage of Participants
Interval 11.81 to 88.19
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
33.3 Percentage of Participants
Interval 11.82 to 61.62
|
53.3 Percentage of Participants
Interval 26.59 to 78.73
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
|
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Progressive Disease (PD)
|
26.3 Percentage of Participants
Interval 9.15 to 51.2
|
66.7 Percentage of Participants
Interval 38.38 to 88.18
|
66.7 Percentage of Participants
Interval 38.38 to 88.18
|
33.3 Percentage of Participants
Interval 4.33 to 77.72
|
100 Percentage of Participants
Interval 39.76 to 100.0
|
46.7 Percentage of Participants
Interval 21.27 to 73.41
|
26.7 Percentage of Participants
Interval 7.79 to 55.1
|
100 Percentage of Participants
Interval 15.81 to 100.0
|
|
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Not Evaluable
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
13.3 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
13.3 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
|
Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Missing
|
10.5 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
16.7 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
13.3 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
0 Percentage of Participants
The 95% CI was only calculated for responses per RECIST, not for participants who were not evaluable or missing.
|
SECONDARY outcome
Timeframe: From randomization up to the first occurrence of disease or death from any cause (up to 4 years)Population: The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), was determined by the investigator according to RECIST v1.1. For participants who did not have documented disease progression or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method.
Outcome measures
| Measure |
Regorafenib (Control)
n=19 Participants
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) as Determined by Investigator According to RECIST v1.1
|
2.83 Months
Interval 2.2 to 3.02
|
1.51 Months
Interval 1.38 to 2.79
|
1.41 Months
Interval 1.41 to 1.77
|
4.21 Months
Interval 1.68 to
The upper limit of the 95% CI was not estimable because too few events had occurred.
|
1.26 Months
Interval 0.82 to
The upper limit of the 95% CI was not estimable because too few events had occurred.
|
1.81 Months
Interval 1.38 to 2.96
|
4.60 Months
Interval 2.6 to 5.78
|
1.58 Months
Interval 1.51 to
The upper limit of the 95% CI was not estimable because too few events had occurred.
|
SECONDARY outcome
Timeframe: From randomization up to death from any cause (up to 4 years)Population: The efficacy evaluable population included all participants who received at least one dose of each study drug for their assigned treatment regimen.
Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier method was used to estimate the median for OS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method.
Outcome measures
| Measure |
Regorafenib (Control)
n=19 Participants
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
10.15 Months
Interval 4.4 to 12.29
|
5.72 Months
Interval 4.37 to 10.51
|
5.13 Months
Interval 3.12 to 7.75
|
14.36 Months
Interval 3.22 to
The upper limit of the 95% CI was not estimable because too few events had occurred.
|
5.93 Months
Interval 1.61 to
The upper limit of the 95% CI was not estimable because too few events had occurred.
|
11.01 Months
Interval 5.29 to 16.66
|
8.67 Months
Interval 6.6 to 14.62
|
4.07 Months
The lower and upper limits of the 95% CI were not estimable because too few events had occurred.
|
SECONDARY outcome
Timeframe: 3, 6, 12, and 18 monthsPopulation: The efficacy evaluable population included all participants who received at least one dose of each study drug for their assigned treatment regimen. The number analyzed at each landmark timepoint indicates the number of participants who were remaining at risk for an event. The event-free rate was not estimable (NE) for landmark timepoints at which 0 participants were remaining at risk for an an event.
Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. OS is shown as the percentage of participants who were event-free at the landmark timepoints of 3, 6, 12, and 18 months.
Outcome measures
| Measure |
Regorafenib (Control)
n=19 Participants
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS)
6 Months
|
63.16 Percentage of Participants
Interval 41.47 to 84.85
|
46.67 Percentage of Participants
Interval 21.42 to 71.91
|
40.00 Percentage of Participants
Interval 15.21 to 64.79
|
80.00 Percentage of Participants
Interval 44.94 to 100.0
|
50.00 Percentage of Participants
Interval 1.0 to 99.0
|
71.79 Percentage of Participants
Interval 48.32 to 95.27
|
73.33 Percentage of Participants
Interval 50.95 to 95.71
|
—
|
|
Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS)
12 Months
|
34.45 Percentage of Participants
Interval 12.42 to 56.48
|
20.00 Percentage of Participants
Interval 0.0 to 40.24
|
26.67 Percentage of Participants
Interval 4.29 to 49.05
|
53.33 Percentage of Participants
Interval 4.68 to 100.0
|
25.00 Percentage of Participants
Interval 0.0 to 67.43
|
39.89 Percentage of Participants
Interval 13.18 to 66.59
|
33.33 Percentage of Participants
Interval 9.48 to 57.19
|
—
|
|
Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS)
3 Months
|
84.21 Percentage of Participants
Interval 67.81 to 100.0
|
100.00 Percentage of Participants
Interval 100.0 to 100.0
|
73.33 Percentage of Participants
Interval 50.95 to 95.71
|
100.00 Percentage of Participants
Interval 100.0 to 100.0
|
75.00 Percentage of Participants
Interval 32.57 to 100.0
|
78.97 Percentage of Participants
Interval 57.78 to 100.0
|
86.67 Percentage of Participants
Interval 69.46 to 100.0
|
100.00 Percentage of Participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS)
18 Months
|
17.22 Percentage of Participants
Interval 0.0 to 34.87
|
6.67 Percentage of Participants
Interval 0.0 to 19.29
|
20.00 Percentage of Participants
Interval 0.0 to 40.24
|
26.67 Percentage of Participants
Interval 0.0 to 70.97
|
25.00 Percentage of Participants
Interval 0.0 to 67.43
|
23.93 Percentage of Participants
Interval 0.48 to 47.39
|
26.67 Percentage of Participants
Interval 4.29 to 49.05
|
—
|
SECONDARY outcome
Timeframe: From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 4 years)Population: The duration of response analysis included all participants from the efficacy evaluable population who had a confirmed overall response; only 1 participant in each of the atezolizumab + regorafenib arm and the atezolizumab + regorafenib + AB928 arm had a confirmed response.
Duration of response is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause.
Outcome measures
| Measure |
Regorafenib (Control)
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=1 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=1 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
|
—
|
—
|
—
|
—
|
—
|
3.12 Months
Only 1 participant had a confirmed response; 95% CI could not be calculated.
|
5.75 Months
Only 1 participant had a confirmed response; 95% CI could not be calculated.
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression or loss of clinical benefit (up to 4 years)Population: The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen.
Disease control rate is defined as the percentage of participants with stable disease for ≥12 weeks or a complete or partial response, as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Regorafenib (Control)
n=19 Participants
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR), as Determined by the Investigator Per RECIST v1.1
|
15.8 Percentage of Participants
Interval 3.38 to 39.58
|
13.3 Percentage of Participants
Interval 1.66 to 40.46
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
33.3 Percentage of Participants
Interval 4.33 to 77.72
|
0 Percentage of Participants
Interval 0.0 to 60.24
|
13.3 Percentage of Participants
Interval 1.66 to 40.46
|
40.0 Percentage of Participants
Interval 16.34 to 67.71
|
0 Percentage of Participants
Interval 0.0 to 84.19
|
SECONDARY outcome
Timeframe: Adverse event data were collected from baseline up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from baseline through survival follow-up (up to 4 years)Population: The safety-evaluable population included all patients who received any amount of dose of any component of study treatment.
The incidence, nature, and severity of adverse events (AEs) are reported, with severity determined according to NCI CTCAE v4.0. All AEs were reported until 30 days after the last study dose or until start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest were reported until 135 days (or 180 days for the Atezolizumab + LOAd703 arm only) after the last dose of study treatment.
Outcome measures
| Measure |
Regorafenib (Control)
n=19 Participants
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 Participants
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE)
AE with a Fatal Outcome
|
10.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
SAE Leading to Dose Modification/Interruption
|
5.3 Percentage of Participants
|
0 Percentage of Participants
|
6.7 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
26.7 Percentage of Participants
|
46.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Related SAE
|
5.3 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
26.7 Percentage of Participants
|
33.3 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Adverse Event (AE)
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Death
|
89.5 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
66.7 Percentage of Participants
|
100 Percentage of Participants
|
73.3 Percentage of Participants
|
80.0 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Withdrawn from Stage due to an AE
|
15.8 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
6.7 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Serious AE (SAE)
|
26.3 Percentage of Participants
|
6.7 Percentage of Participants
|
33.3 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
46.7 Percentage of Participants
|
46.7 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
AE Leading to Withdrawal from any Treatment
|
26.3 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
20.0 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
AE Leading to Dose Modification/Interruption
|
63.2 Percentage of Participants
|
40.0 Percentage of Participants
|
13.3 Percentage of Participants
|
50.0 Percentage of Participants
|
75.0 Percentage of Participants
|
86.7 Percentage of Participants
|
93.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Related AE
|
94.7 Percentage of Participants
|
86.7 Percentage of Participants
|
86.7 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
93.3 Percentage of Participants
|
100 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
SAE Leading to Withdrawal from any Treatment
|
21.1 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Related AE Leading to Withdrawal from any Treatment
|
10.5 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
6.7 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Related AE Leading to Dose Modification/Interruption
|
47.4 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
75.0 Percentage of Participants
|
73.3 Percentage of Participants
|
93.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Grade 3-5 AE
|
68.4 Percentage of Participants
|
20.0 Percentage of Participants
|
46.7 Percentage of Participants
|
50.0 Percentage of Participants
|
75.0 Percentage of Participants
|
66.7 Percentage of Participants
|
60.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Worst Grade AE: 5
|
10.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Worst Grade AE: 4
|
5.3 Percentage of Participants
|
0 Percentage of Participants
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
6.7 Percentage of Participants
|
13.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With at Least One Adverse Event (AE)
Worst Grade AE: 3
|
52.6 Percentage of Participants
|
20.0 Percentage of Participants
|
40.0 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
53.3 Percentage of Participants
|
46.7 Percentage of Participants
|
0 Percentage of Participants
|
Adverse Events
Regorafenib (Control)
Serious events: 5 serious events
Other events: 19 other events
Deaths: 18 deaths
Atezolizumab + Imprime PGG + Bevacizumab
Serious events: 1 serious events
Other events: 15 other events
Deaths: 15 deaths
Atezolizumab + Isatuximab
Serious events: 5 serious events
Other events: 15 other events
Deaths: 15 deaths
Atezolizumab + Selicrelumab + Bevacizumab
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Atezolizumab + Idasanutlin
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Atezolizumab + Regorafenib
Serious events: 7 serious events
Other events: 15 other events
Deaths: 11 deaths
Atezolizumab + Regorafenib + AB928
Serious events: 7 serious events
Other events: 15 other events
Deaths: 12 deaths
Atezolizumab + LOAd703
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Regorafenib (Control)
n=19 participants at risk
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Asthenia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Perforation
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Hepatobiliary disorders
Biliary obstruction
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Biliary tract infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Enterocolitis infectious
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Sepsis
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Blood bilirubin increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
Other adverse events
| Measure |
Regorafenib (Control)
n=19 participants at risk
Participants will receive treatment until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Atezolizumab + Imprime PGG + Bevacizumab
n=15 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Isatuximab
n=15 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Selicrelumab + Bevacizumab
n=6 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Idasanutlin
n=4 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib
n=15 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + Regorafenib + AB928
n=15 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
Atezolizumab + LOAd703
n=2 participants at risk
Participants will receive treatment until unacceptable toxicity or loss of clinical benefit as confirmed by disease progression per RECIST V1.1 or lack of continued benefit as determined by the investigator.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Endocrine disorders
Hypothyroidism
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Eye disorders
Vision blurred
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
26.3%
5/19 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Ascites
|
5.3%
1/19 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Colitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Constipation
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.6%
6/19 • Number of events 9 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
40.0%
6/15 • Number of events 9 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
2/4 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
46.7%
7/15 • Number of events 8 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Nausea
|
36.8%
7/19 • Number of events 7 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
40.0%
6/15 • Number of events 8 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
100.0%
4/4 • Number of events 11 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Odynophagia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Oral pain
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 7 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
100.0%
4/4 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Asthenia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
2/6 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
5/15 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Chest pain
|
15.8%
3/19 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Chills
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Device related thrombosis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Face oedema
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Fatigue
|
42.1%
8/19 • Number of events 8 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
46.7%
7/15 • Number of events 11 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
60.0%
9/15 • Number of events 11 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
46.7%
7/15 • Number of events 8 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
100.0%
2/2 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
General physical health deterioration
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Inflammation
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Influenza like illness
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Injection site reaction
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
83.3%
5/6 • Number of events 9 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Medical device site erythema
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Mucosal inflammation
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Non-cardiac chest pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Oedema
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Pain
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Peripheral swelling
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Pyrexia
|
15.8%
3/19 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
46.7%
7/15 • Number of events 9 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Swelling face
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Hepatobiliary disorders
Jaundice
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Otitis media
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Sepsis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
53.3%
8/15 • Number of events 16 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
73.3%
11/15 • Number of events 13 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 7 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.8%
3/19 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.3%
5/19 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Hyperaesthesia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Product Issues
Device occlusion
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Psychiatric disorders
Agitation
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Reproductive system and breast disorders
Perineal fistula
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
26.3%
5/19 • Number of events 7 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
1/2 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
63.2%
12/19 • Number of events 18 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
5/15 • Number of events 7 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
40.0%
6/15 • Number of events 8 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Vascular disorders
Hypertension
|
31.6%
6/19 • Number of events 7 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Vascular disorders
Vena cava thrombosis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
16.7%
1/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Injury, poisoning and procedural complications
Stoma site rash
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Alanine aminotransferase increased
|
21.1%
4/19 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
3/19 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
2/4 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Blood bilirubin increased
|
21.1%
4/19 • Number of events 5 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
2/4 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.5%
2/19 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Electrocardiogram QT prolonged
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Lipase increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Neutrophil count decreased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Platelet count decreased
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
Weight decreased
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Investigations
White blood cell count decreased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.6%
6/19 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
5/15 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
40.0%
6/15 • Number of events 6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
33.3%
5/15 • Number of events 7 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/19 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/6 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/4 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/15 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
0.00%
0/2 • Adverse event data were collected from first study dose up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from enrolment through survival follow-up (up to 4 years).
All-Cause Mortality is reported in the all-enrolled patients population. Adverse events (AEs) are reported in the safety population, defined as all those who received ≥1 dose of study treatment. One participant in the Regorafenib arm died before receiving study dose. All AEs were reported until 30 days after the last study dose or until the start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest are reported until up to 180 days after last study dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER