Trial Outcomes & Findings for A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors (NCT NCT04704154)
NCT ID: NCT04704154
Last Updated: 2025-04-18
Results Overview
Tumor response was evaluated as ORR per RECIST 1.1 by local assessments for all tumor types, except for GBM/AA, where ORR per RANO by local assessment was used. ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR). Participants for whom best overall tumor response was not CR or PR, as well as participants without any post-baseline tumor assessment were considered non-responders. Descriptive statistics were done, no inferential statistical analyses were performed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
175 participants
Primary outcome timeframe
From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months
Results posted on
2025-04-18
Participant Flow
The study was conducted at 34 study centers in 8 countries/regions from 03 February 2021 (first patient first visit) to 29 March 2024 (last patient last visit)
175 participants were enrolled and received study treatment. Participants were enrolled in 6 cohorts: HNSCC IO naïve (N=30), HNSCC IO treated (N=20), ESCC (N=30), PDAC (N=20), BTC (N=45), and GBM/AA (N=30)
Participant milestones
| Measure |
HNSCC (IO Naive)
Participants with confirmed recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) without Immune-oncology (IO), received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
HNSCC (IO Treated)
Participants with confirmed recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) and with Immune-oncology (IO) treated, received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
ESCC
Participants with confirmed recurrent or metastatic Esophageal Squamous Cell Carcinoma (ESCC) received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
PDAC
Participants with confirmed recurrent or metastatic Pancreatic Duct Adenocarcinoma (PADC) received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
Biliary Tract Cancer (BTC)
Participants with confirmed recurrent or metastatic BTC received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
GBM/AA
Participants with Glioblastoma Multiforme (GBM) or Anaplastic Astrocytoma (AA) received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
20
|
30
|
20
|
45
|
30
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
20
|
30
|
20
|
45
|
30
|
Reasons for withdrawal
| Measure |
HNSCC (IO Naive)
Participants with confirmed recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) without Immune-oncology (IO), received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
HNSCC (IO Treated)
Participants with confirmed recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) and with Immune-oncology (IO) treated, received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
ESCC
Participants with confirmed recurrent or metastatic Esophageal Squamous Cell Carcinoma (ESCC) received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
PDAC
Participants with confirmed recurrent or metastatic Pancreatic Duct Adenocarcinoma (PADC) received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
Biliary Tract Cancer (BTC)
Participants with confirmed recurrent or metastatic BTC received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
GBM/AA
Participants with Glioblastoma Multiforme (GBM) or Anaplastic Astrocytoma (AA) received 480 mg nivolumab intravenously on day 1 of every treatment cycle. Regorafenib was given as 30 mg tablets daily (QD) for 3 weeks of each treatment cycle (28 days cycle length) with a starting dose of 90 mg that could be escalated to 120 mg if well tolerated.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
4
|
2
|
3
|
0
|
|
Overall Study
Death
|
3
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
Participant Decision
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
19
|
17
|
20
|
18
|
36
|
30
|
|
Overall Study
Completed max. allowed treatment. A max. of 24 infusions of Nivolumab were allowed for participants
|
2
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Patient continued in rollover study for regorafenib
|
1
|
0
|
4
|
0
|
0
|
0
|
Baseline Characteristics
A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors
Baseline characteristics by cohort
| Measure |
HNSCC (IO Naive)
n=30 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 Participants
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
95 Participants
n=8 Participants
|
|
Age, Customized
65-<75 years
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
63 Participants
n=8 Participants
|
|
Age, Customized
75-<85 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
55 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
120 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
65 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
85 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 monthsPopulation: FAS: all participants who received study treatment were included in the full analysis set
Tumor response was evaluated as ORR per RECIST 1.1 by local assessments for all tumor types, except for GBM/AA, where ORR per RANO by local assessment was used. ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR). Participants for whom best overall tumor response was not CR or PR, as well as participants without any post-baseline tumor assessment were considered non-responders. Descriptive statistics were done, no inferential statistical analyses were performed.
Outcome measures
| Measure |
HNSCC (IO Naive)
n=30 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 Participants
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
6 Participants
|
1 Participants
|
15 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 monthsPopulation: Subgroup of participants that had a best overall response of CR or PR that had received the study treatment
Defined as the time (in days) from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. participants with a CR or PR.
Outcome measures
| Measure |
HNSCC (IO Naive)
n=6 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=1 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=15 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=2 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=1 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
NA Days
Interval 654.0 to
Value cannot be estimated due to censored data, insufficient number of participants with events
|
NA Days
Value cannot be estimated due to censored data, insufficient number of participants with events
|
420 Days
Interval 112.0 to 617.0
|
—
|
432 Days
Interval 112.0 to
Value cannot be estimated due to censored data, insufficient number of participants with events
|
140 Days
Value cannot be estimated due to censored data, insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 monthsPopulation: FAS: all participants who received study treatment were included in the full analysis set
CR = Complete response; PR = Partial response; SD = Stable disease
Outcome measures
| Measure |
HNSCC (IO Naive)
n=30 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 Participants
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
16 Participants
|
13 Participants
|
22 Participants
|
7 Participants
|
24 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 monthsPopulation: FAS: all participants who received study treatment were included in the full analysis set
PFS was defined as the time (in days) from the start of study intervention to the date of first objectively documented progressive disease (PD) or death from any cause (if no progression was documented).
Outcome measures
| Measure |
HNSCC (IO Naive)
n=30 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 Participants
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
79 Days
Interval 50.0 to 227.0
|
105 Days
Interval 52.0 to 115.0
|
259 Days
Interval 110.0 to 472.0
|
53 Days
Interval 48.0 to 111.0
|
98 Days
Interval 55.0 to 112.0
|
55 Days
Interval 52.0 to 84.0
|
SECONDARY outcome
Timeframe: Up to last participant follow 6 months (approximately 22 months)Population: FAS: all participants who received study treatment were included in the full analysis set
6 Months PFS rate
Outcome measures
| Measure |
HNSCC (IO Naive)
n=30 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 Participants
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
6 Months PFS
|
0.455 Proportion of participants
Interval 0.337 to 0.573
|
0.263 Proportion of participants
Interval 0.134 to 0.393
|
0.533 Proportion of participants
Interval 0.417 to 0.65
|
0.050 Proportion of participants
Interval 0.0 to 0.112
|
0.148 Proportion of participants
Interval 0.077 to 0.218
|
0.167 Proportion of participants
Interval 0.079 to 0.254
|
SECONDARY outcome
Timeframe: From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 monthsPopulation: FAS: all participants who received study treatment were included in the full analysis set
OS was defined as the time (in days) from the start of study intervention to the date of death due to any cause.
Outcome measures
| Measure |
HNSCC (IO Naive)
n=30 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 Participants
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
358 Days
Interval 198.0 to 418.0
|
355 Days
Interval 126.0 to 614.0
|
627 Days
Interval 431.0 to 865.0
|
259 Days
Interval 134.0 to 311.0
|
246 Days
Interval 176.0 to 386.0
|
245 Days
Interval 127.0 to 377.0
|
SECONDARY outcome
Timeframe: From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 month]Population: FAS: all participants who received study treatment were included in the full analysis set
Outcome measures
| Measure |
HNSCC (IO Naive)
n=30 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 Participants
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
1 Year OS
|
0.415 Proportion of participants
Interval 0.298 to 0.532
|
0.444 Proportion of participants
Interval 0.294 to 0.595
|
0.764 Proportion of participants
Interval 0.664 to 0.864
|
0.281 Proportion of participants
Interval 0.145 to 0.418
|
0.422 Proportion of participants
Interval 0.323 to 0.521
|
0.337 Proportion of participants
Interval 0.223 to 0.451
|
SECONDARY outcome
Timeframe: Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 monthsPopulation: Safety analysis set (SAF): all participants who received study treatment were included in the safety analysis set. As the safety analysis set equals the full analysis, all safety related analysis were performed on the full analysis set.
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
Outcome measures
| Measure |
HNSCC (IO Naive)
n=30 Participants
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 Participants
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 Participants
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 Participants
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 Participants
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 Participants
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any AE
|
30 Participants
|
20 Participants
|
30 Participants
|
20 Participants
|
45 Participants
|
30 Participants
|
|
Number of Participants With Adverse Events
Worst grade: Grade 1
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Worst grade: Grade 2
|
4 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events
Worst grade: Grade 3
|
16 Participants
|
16 Participants
|
18 Participants
|
11 Participants
|
23 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events
Worst grade: Grade 4
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Worst grade: Grade 5 (death)
|
3 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
9 Participants
|
Adverse Events
HNSCC (IO Naive)
Serious events: 22 serious events
Other events: 30 other events
Deaths: 22 deaths
HNSCC (IO Treated)
Serious events: 15 serious events
Other events: 20 other events
Deaths: 17 deaths
ESCC
Serious events: 19 serious events
Other events: 30 other events
Deaths: 20 deaths
PDAC
Serious events: 13 serious events
Other events: 20 other events
Deaths: 17 deaths
Biliary Tract Cancer (BTC)
Serious events: 28 serious events
Other events: 45 other events
Deaths: 36 deaths
GBM/AA
Serious events: 13 serious events
Other events: 29 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
HNSCC (IO Naive)
n=30 participants at risk
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 participants at risk
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 participants at risk
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 participants at risk
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 participants at risk
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 participants at risk
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
Product Issues
Device deposit issue
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Cardiac disorders
Cardiac failure
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Cardiac disorders
Myocardial infarction
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Death
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Face oedema
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Mucosal inflammation
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Pyrexia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Performance status decreased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
General physical health deterioration
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.6%
7/45 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
30.0%
9/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Hepatitis
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Atypical pneumonia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Infection
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Pneumonia
|
13.3%
4/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
4/20 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Pneumonia aspiration
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Septic shock
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Oral infection
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Rectal abscess
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
COVID-19 pneumonia
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Platelet count decreased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Weight decreased
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Liver function test increased
|
3.3%
1/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Crystal arthropathy
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Coma
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Seizure
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Ureterolithiasis
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Surgical and medical procedures
Bile duct stent insertion
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Product Issues
Device occlusion
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
Other adverse events
| Measure |
HNSCC (IO Naive)
n=30 participants at risk
Participants with confirmed recurrent or metastatic HNSCC and IO naive, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
HNSCC (IO Treated)
n=20 participants at risk
Participants with confirmed recurrent or metastatic HNSCC and with IO treated, received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
ESCC
n=30 participants at risk
Participants with confirmed recurrent or metastatic ESCC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
PDAC
n=20 participants at risk
Participants with confirmed recurrent or metastatic PADC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
Biliary Tract Cancer (BTC)
n=45 participants at risk
Participants with confirmed recurrent or metastatic BTC received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
GBM/AA
n=30 participants at risk
Participants with GBM or AA received regorafenib in combination with nivolumab. (treatment details refers to Description under Participant Flow section above)
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
10/30 • Number of events 24 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 12 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
30.0%
6/20 • Number of events 16 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.6%
7/45 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
1/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
9/45 • Number of events 11 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
5/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
6/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
3/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
25.0%
5/20 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
26.7%
8/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Eye disorders
Cataract
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
35.0%
7/20 • Number of events 13 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
24.4%
11/45 • Number of events 16 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
17.8%
8/45 • Number of events 12 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Aptyalism
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Constipation
|
23.3%
7/30 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
40.0%
8/20 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
23.3%
7/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
35.0%
7/20 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
33.3%
15/45 • Number of events 20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
36.7%
11/30 • Number of events 15 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.3%
7/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
36.7%
11/30 • Number of events 25 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
37.8%
17/45 • Number of events 31 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
6/30 • Number of events 11 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Dysphagia
|
13.3%
4/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
35.0%
7/20 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
31.1%
14/45 • Number of events 19 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Odynophagia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
2/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
5/30 • Number of events 16 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
25.0%
5/20 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
17.8%
8/45 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
6.7%
2/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Asthenia
|
33.3%
10/30 • Number of events 17 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
23.3%
7/30 • Number of events 24 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
4/20 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
26.7%
12/45 • Number of events 36 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
33.3%
10/30 • Number of events 14 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Chest discomfort
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Chest pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Chills
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Fatigue
|
13.3%
4/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
35.0%
7/20 • Number of events 16 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
30.0%
9/30 • Number of events 19 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
40.0%
8/20 • Number of events 18 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
42.2%
19/45 • Number of events 43 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Generalised oedema
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Impaired healing
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Malaise
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Mucosal inflammation
|
13.3%
4/30 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 14 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Oedema peripheral
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
8.9%
4/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Pain
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
General disorders
Pyrexia
|
20.0%
6/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
30.0%
6/20 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
40.0%
12/30 • Number of events 20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
35.0%
7/20 • Number of events 14 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
37.8%
17/45 • Number of events 43 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Cholestasis
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
8.9%
4/45 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Bacteraemia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Influenza
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Paronychia
|
6.7%
2/30 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Pneumonia
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Skin infection
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
Vascular device infection
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Infections and infestations
COVID-19
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
8.9%
4/45 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Alanine aminotransferase increased
|
23.3%
7/30 • Number of events 14 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
8.9%
4/45 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 12 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Amylase increased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
5/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 12 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
6/45 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
6/30 • Number of events 11 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.3%
1/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Heart rate increased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Lipase increased
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
6/30 • Number of events 13 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Lymphocyte count decreased
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 12 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Neutrophil count increased
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Platelet count decreased
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Weight decreased
|
20.0%
6/30 • Number of events 11 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
6/30 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
White blood cell count increased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
Platelet count increased
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
6/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
5/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
25.0%
5/20 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
8.9%
4/45 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
4/30 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
8.9%
4/45 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Refeeding syndrome
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.7%
8/30 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
45.0%
9/20 • Number of events 16 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
36.7%
11/30 • Number of events 26 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
35.0%
7/20 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
31.1%
14/45 • Number of events 25 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
6/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Amyotrophy
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
6/45 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
22.2%
10/45 • Number of events 12 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.6%
7/45 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
4/20 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Dysgeusia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
6/30 • Number of events 13 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Seizure
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Psychiatric disorders
Confusional state
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Psychiatric disorders
Depression
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
4/20 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.6%
7/45 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Dysuria
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Hydronephrosis
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
2/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
4/20 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
8.9%
4/45 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
20.0%
9/45 • Number of events 9 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
2/30 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
8.9%
4/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
3/45 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 10 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
6/45 • Number of events 6 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
26.7%
8/30 • Number of events 11 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
45.0%
9/20 • Number of events 28 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
73.3%
22/30 • Number of events 45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
25.0%
5/20 • Number of events 16 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
33.3%
15/45 • Number of events 37 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
26.7%
8/30 • Number of events 18 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
3/30 • Number of events 4 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 5 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
6.7%
2/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
6/30 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
46.7%
14/30 • Number of events 23 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
40.0%
8/20 • Number of events 14 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
22.2%
10/45 • Number of events 22 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
16.7%
5/30 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
15.0%
3/20 • Number of events 3 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
11.1%
5/45 • Number of events 8 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Vascular disorders
Haematoma
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Vascular disorders
Hypertension
|
16.7%
5/30 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
35.0%
7/20 • Number of events 12 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
13.3%
4/30 • Number of events 7 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
30.0%
6/20 • Number of events 13 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
24.4%
11/45 • Number of events 25 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
26.7%
8/30 • Number of events 16 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
10.0%
2/20 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
4.4%
2/45 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
3.3%
1/30 • Number of events 2 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/45 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
|
Vascular disorders
Hot flush
|
3.3%
1/30 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/20 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
5.0%
1/20 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
2.2%
1/45 • Number of events 1 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
0.00%
0/30 • Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
AEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60