Trial Outcomes & Findings for First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib (NCT NCT01289821)
NCT ID: NCT01289821
Last Updated: 2017-03-15
Results Overview
OR was defined as the best tumor response (confirmed complete response \[CR\] or partial response \[PR\]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing nontarget lesions and no appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.
Results posted on
2017-03-15
Participant Flow
Male or female participants with histological or cytological documentation of adenocarcinoma of the colon or rectum that was unresectable or unlikely of becomining resectable, who were at least 18 years of age and were suitable to receive mFOLFOX6 regimen as first line treatment could participate in this study at 16 centers in 7 countries.
Of 66 enrolled participants, 54 received study medication, 4 withdrew consent during screening, and 8 were screen failures due to no measurable lesion, not suitable to receive mFOLFOX as 1st line regimen (2), uncontrolled hypertension, symptoms/signs/history of brain metastases, glomerular filtration rate too low (2), and protein in spot urine
Participant milestones
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Treatment Period
STARTED
|
54
|
|
Treatment Period
Participants Received Regorafenib
|
54
|
|
Treatment Period
COMPLETED
|
0
|
|
Treatment Period
NOT COMPLETED
|
54
|
|
Safety Follow-up Period
STARTED
|
54
|
|
Safety Follow-up Period
COMPLETED
|
49
|
|
Safety Follow-up Period
NOT COMPLETED
|
5
|
|
Survival Follow-up Period
STARTED
|
52
|
|
Survival Follow-up Period
COMPLETED
|
34
|
|
Survival Follow-up Period
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Treatment Period
Withdrawal by Subject
|
1
|
|
Treatment Period
Physician Decision
|
3
|
|
Treatment Period
Adverse Event
|
4
|
|
Treatment Period
Radiological Progression
|
43
|
|
Treatment Period
Clinical Progression
|
2
|
|
Treatment Period
Therapeutic procedure required
|
1
|
|
Safety Follow-up Period
Withdrawal by Subject
|
1
|
|
Safety Follow-up Period
Protocol Violation
|
3
|
|
Safety Follow-up Period
Unspecified reason
|
1
|
|
Survival Follow-up Period
Protocol Violation
|
1
|
|
Survival Follow-up Period
Lost to Follow-up
|
1
|
|
Survival Follow-up Period
Clinical endpoint reached
|
16
|
Baseline Characteristics
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
Baseline characteristics by cohort
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=54 Participants
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Age, Customized
< 65 years
|
33 Participants
n=93 Participants
|
|
Age, Customized
65 - 75 years
|
18 Participants
n=93 Participants
|
|
Age, Customized
> 75 years
|
3 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Female
|
26 Paricipants
n=93 Participants
|
|
Sex/Gender, Customized
Male
|
28 Paricipants
n=93 Participants
|
|
Caucasian
|
54 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at study entry
0
|
35 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at study entry
1
|
19 Participants
n=93 Participants
|
|
Stage at initial diagnosis
I
|
1 Participants
n=93 Participants
|
|
Stage at initial diagnosis
IIA
|
5 Participants
n=93 Participants
|
|
Stage at initial diagnosis
IIIB
|
3 Participants
n=93 Participants
|
|
Stage at initial diagnosis
IIIC
|
4 Participants
n=93 Participants
|
|
Stage at initial diagnosis
IV
|
41 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.Population: Primary analysis set (PAS, N=41) was a subset of the PPS and included the first 41 subjects, who were assigned to treatment
OR was defined as the best tumor response (confirmed complete response \[CR\] or partial response \[PR\]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing nontarget lesions and no appearance of new lesions.
Outcome measures
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=41 Participants
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Objective Response (OR)
|
0.4390 Proportion of participants
|
SECONDARY outcome
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeksPopulation: Full analysis set (FAS, N=54) included all subjects who received treatment.
OS was calculated as the time from first date of receiving study treatment to date of death due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.
Outcome measures
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=54 Participants
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Overall Survival (OS)
|
772 Days
Interval 646.0 to 1089.0
|
SECONDARY outcome
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeksPopulation: Full analysis set (FAS)
PFS was defined as time from the date of start of study treatment to the date of first observed disease progression (radiological according to central assessment or clinical), or death due to any cause, if death occurred before progression was documented. PFS for participants without disease progression or death at the date of database cutoff were right-censored at the last date of tumor assessment. Participants who had no tumor evaluation after baseline and no clinical progression post baseline and who did not die were censored at Day 1 in the analysis. PD = At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non target lesions or the appearance of one or more new lesions will also constitute PD.
Outcome measures
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=54 Participants
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Progression-free Survival (PFS)
|
258 Days
Interval 222.0 to 334.0
|
SECONDARY outcome
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeksPopulation: PAS
DC was defined as the proportion of participants who had a best response rating of CR, PR, or stable disease (SD) according to RECIST criteria that was achieved during treatment or within 30 days after termination of study treatment. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. A minimum of 8 weeks (allowing a minus 7-day time window) between start of study treatment and the first follow-up tumor assessment with SD as response was required to assign SD as best overall response.
Outcome measures
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=41 Participants
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Disease Control (DC)
|
0.8537 Proportion of participants
|
SECONDARY outcome
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeksPopulation: Per protocol set (PPS)
DOR was defined as the time from the date of first documented objective response of PR or CR, whichever was noted earlier, to first subsequent disease progression or death (if death occurred before progression was documented). DOR was defined for responders only (that is, subjects with CR or PR). DOR for subjects without disease progression or death before progression was right censored at the date of their last tumor assessment.
Outcome measures
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=20 Participants
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Duration of Response (DOR)
|
257 Days
Interval 176.0 to 349.0
|
SECONDARY outcome
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeksPopulation: Per protocol set (PPS)
DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD. DOSR was defined as the time (in days) from date of start of study treatment to the date at which disease progression or death (if death occurred before progression was first documented). The date the tumor scan was performed was used for this calculation. DOSD for participants without disease progression or death before progression at the time of analysis were censored at the date of their last tumor assessment.
Outcome measures
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=22 Participants
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Duration of Stable Disease (DOSD)
|
231 Days
Interval 167.0 to 259.0
|
Adverse Events
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
Serious events: 25 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=53 participants at risk
On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Cardiac disorders
Atrial flutter
|
1.9%
1/53 • Number of events 2 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
Fever
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
Infusion related reaction
|
1.9%
1/53 • Number of events 2 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Blood bilirubin increased
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Catheter related infection
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Sepsis
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Skin infection
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
13.2%
7/53 • Number of events 9 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • Number of events 1 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Vascular disorders
Thromboembolic event
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
Other adverse events
| Measure |
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)
n=53 participants at risk
On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
22.6%
12/53 • Number of events 25 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Cardiac disorders
Conduction disorder
|
7.5%
4/53 • Number of events 8 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Cardiac disorders
Sinus bradycardia
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Endocrine disorders
Hypothyroidism
|
11.3%
6/53 • Number of events 8 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Abdominal pain
|
52.8%
28/53 • Number of events 47 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Constipation
|
32.1%
17/53 • Number of events 26 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Diarrhea
|
69.8%
37/53 • Number of events 124 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.3%
6/53 • Number of events 7 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Mucositis oral
|
45.3%
24/53 • Number of events 65 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Nausea
|
52.8%
28/53 • Number of events 70 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.5%
4/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Rectal pain
|
7.5%
4/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Gastrointestinal disorders
Vomiting
|
30.2%
16/53 • Number of events 29 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
Fatigue
|
64.2%
34/53 • Number of events 92 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
Fever
|
18.9%
10/53 • Number of events 18 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
Infusion related reaction
|
5.7%
3/53 • Number of events 7 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
Injection site reaction
|
7.5%
4/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.7%
3/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
General disorders
Pain
|
24.5%
13/53 • Number of events 15 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Alanine aminotransferase increased
|
18.9%
10/53 • Number of events 27 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Alkaline phosphatase increased
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Aspartate aminotransferase increased
|
22.6%
12/53 • Number of events 29 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Blood bilirubin increased
|
17.0%
9/53 • Number of events 15 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
GGT increased
|
15.1%
8/53 • Number of events 17 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Lipase increased
|
26.4%
14/53 • Number of events 19 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Neutrophil count decreased
|
66.0%
35/53 • Number of events 88 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Investigations - Other, specify
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Platelet count decreased
|
47.2%
25/53 • Number of events 61 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Serum amylase increased
|
9.4%
5/53 • Number of events 8 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
White blood cell decreased
|
11.3%
6/53 • Number of events 8 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Investigations
Weight loss
|
9.4%
5/53 • Number of events 7 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Immune system disorders
Allergic reaction
|
9.4%
5/53 • Number of events 5 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Catheter related infection
|
5.7%
3/53 • Number of events 5 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.5%
4/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Paronychia
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Upper respiratory infection
|
11.3%
6/53 • Number of events 10 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Infections and infestations
Urinary tract infection
|
9.4%
5/53 • Number of events 7 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Metabolism and nutrition disorders
Anorexia
|
39.6%
21/53 • Number of events 41 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.3%
6/53 • Number of events 7 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.3%
6/53 • Number of events 9 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.5%
4/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
26.4%
14/53 • Number of events 35 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.3%
6/53 • Number of events 10 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.9%
10/53 • Number of events 15 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.7%
3/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.4%
5/53 • Number of events 6 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Dizziness
|
11.3%
6/53 • Number of events 6 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Dysgeusia
|
30.2%
16/53 • Number of events 18 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Dysesthesia
|
13.2%
7/53 • Number of events 14 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Headache
|
15.1%
8/53 • Number of events 15 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Lethargy
|
18.9%
10/53 • Number of events 29 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Paresthesia
|
52.8%
28/53 • Number of events 71 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
45.3%
24/53 • Number of events 47 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Nervous system disorders
Somnolence
|
5.7%
3/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Eye disorders
Conjunctivitis
|
5.7%
3/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.7%
3/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Psychiatric disorders
Insomnia
|
9.4%
5/53 • Number of events 6 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
5/53 • Number of events 8 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.2%
7/53 • Number of events 12 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
13.2%
7/53 • Number of events 11 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.5%
4/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
22.6%
12/53 • Number of events 29 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Renal and urinary disorders
Hematuria
|
5.7%
3/53 • Number of events 4 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.3%
15/53 • Number of events 15 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.4%
5/53 • Number of events 6 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.7%
3/53 • Number of events 5 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.3%
6/53 • Number of events 7 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
35.8%
19/53 • Number of events 47 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
4/53 • Number of events 5 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.4%
5/53 • Number of events 5 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.3%
6/53 • Number of events 10 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Vascular disorders
Flushing
|
9.4%
5/53 • Number of events 8 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Vascular disorders
Hypotension
|
9.4%
5/53 • Number of events 5 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Vascular disorders
Hypertension
|
56.6%
30/53 • Number of events 134 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Vascular disorders
Phlebitis
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
|
Vascular disorders
Thromboembolic event
|
5.7%
3/53 • Number of events 3 • From start of study treatment until 4 weeks following the last dose of study treatment.
Of 54 treated subjects, 53 subjects were valid for safety population. One subject was excluded from the SAF. The reason for the exclusion "never received regorafenib" is only enumerated once, under the reasons for exclusion from the SAF.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI has to submit a draft manuscript of the publication or abstract to Bayer for review and approval at least 60 days before submission. Possible discrepancies will be discussed to find solution which satifies both parties. Bayer may delay publication for up to three months after analyzing the results.
- Publication restrictions are in place
Restriction type: OTHER