Trial Outcomes & Findings for A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC (NCT NCT00664326)
NCT ID: NCT00664326
Last Updated: 2021-01-29
Results Overview
Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\] or Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Results posted on
2021-01-29
Participant Flow
Male or female untreated participants, who were at least 18 years of age, with metastatic and/or unresectable, measurable predominantly clear cell renal cell cancer (RCC) histologically or cytologically documented could participate in this study at 18 centers in 6 countries.
Of 64 enrolled participants, 49 received study medication, and 15 were screen failures due to protocol violation (12 participants), withdrawal of consent (1 participant), adverse event (2 participants).
Participant milestones
| Measure |
Regorafenib (Stivarga, BAY73-4506)
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
| Measure |
Regorafenib (Stivarga, BAY73-4506)
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Noncompliance with study medication
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Other Reasons
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease Progression/Recurrence/Relapse
|
24
|
Baseline Characteristics
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
Baseline characteristics by cohort
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=49 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Age, Continuous
|
62.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0
|
30 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1
|
19 Participants
n=5 Participants
|
|
Overall Motzer Score
Low
|
24 Participants
n=5 Participants
|
|
Overall Motzer Score
Intermediate
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Evaluable for response (Primary analysis population)
Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\] or Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=48 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Objective Tumor Response
|
31.3 Percentage of participants
|
PRIMARY outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Evaluable for response (Primary analysis population)
Tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\], Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\], Stable Disease \[SD, steady state of disease\], or Progressive Disease \[PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions\]) observed during trial period assessed according to the RECIST committee.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=48 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Tumor Response
Complete Response (CR)
|
0.0 Percentage of participants
|
|
Tumor Response
Partial Response (PR)
|
31.3 Percentage of participants
|
|
Tumor Response
Stable Disease (SD)
|
50.0 Percentage of participants
|
|
Tumor Response
Progressive Disease (PD)
|
10.4 Percentage of participants
|
|
Tumor Response
Not Assessable
|
8.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Evaluable for response (Primary analysis population)
Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=48 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Disease Control
|
62.5 Percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).Population: intention-to-treat (ITT)
Overall survival (OS) was calculated as the time from the first date of receiving study medication to 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 (Stivarga, BAY73-4506)
n=49 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Overall Survival
|
NA Days
Interval 285.0 to
Not estimable due to censored data.
|
SECONDARY outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: intention-to-treat (ITT)
PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=49 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Progression-free Survival (PFS)
|
251 Days
Interval 160.0 to
Not estimable due to censored data.
|
SECONDARY outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: intention-to-treat (ITT)
TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=49 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Time to Progression (TTP)
|
251 Days
Interval 167.0 to
Not estimable due to censored data.
|
SECONDARY outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Only subjects from ITT population with a response of CR or PR were included in this evaluation.
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=15 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Duration of Response
|
NA Days
Interval 140.0 to
Not estimable due to censored data.
|
SECONDARY outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.
Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=29 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Duration of Stable Disease (SD)
|
172 Days
Interval 107.0 to
Not estimable due to censored data.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Evaluable for response (Primary analysis population)
Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\] or Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\]) observed during trial period assessed according to the RECIST committee.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=48 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Objective Tumor Response (Update)
|
39.6 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Evaluable for response (Primary analysis population)
Tumor response of a participant was defined as the best tumor response (confirmed Complete Response \[CR, tumor disappears\], Partial Response \[PR, sum of lesion sizes decreased at least 30% from baseline\], Stable Disease \[SD, steady state of disease\], or Progressive Disease \[PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions\]) observed during trial period assessed according to the RECIST committee.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=48 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Tumor Response (Update)
Complete Response (CR)
|
0.0 Percentage of participants
|
|
Tumor Response (Update)
Partial Response (PR)
|
39.6 Percentage of participants
|
|
Tumor Response (Update)
Stable Disease (SD)
|
41.7 Percentage of participants
|
|
Tumor Response (Update)
Progressive Disease (PD)
|
10.4 Percentage of participants
|
|
Tumor Response (Update)
Not Assessable
|
8.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Evaluable for response (Primary analysis population)
Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=48 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Disease Control (Update)
|
62.5 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).Population: intention-to-treat (ITT)
Overall survival (OS) was calculated as the time from the first date of receiving study medication to 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 (Stivarga, BAY73-4506)
n=49 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Overall Survival (Update)
|
NA Days
Interval 735.0 to
Not estimable due to censored data.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: intention-to-treat (ITT)
PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=49 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Progression-free Survival (Update)
|
335 Days
Interval 167.0 to 438.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: intention-to-treat (ITT)
TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=49 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Time to Progression (Update)
|
335 Days
Interval 167.0 to 454.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Only subjects from ITT population with a response of CR or PR were included in this evaluation.
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=19 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Duration of Response (Update)
|
428 Days
Interval 250.0 to 540.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksPopulation: Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.
Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.
Outcome measures
| Measure |
Regorafenib (Stivarga, BAY73-4506)
n=25 Participants
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
|
|---|---|
|
Duration of Stable Disease (Update)
|
119 Days
Interval 105.0 to 335.0
|
Adverse Events
Regorafenib (BAY73-4506)
Serious events: 32 serious events
Other events: 48 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Regorafenib (BAY73-4506)
n=49 participants at risk
Subjects received regorafenib 160 mg po qd for 3 weeks of every 4 week cycle (3 weeks on, 1 week off).
|
|---|---|
|
Cardiac disorders
Angina unstable
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Cardiac disorders
Cardiac arrest
|
4.1%
2/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Cardiac disorders
Myocardial infarction
|
4.1%
2/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Haematemesis
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Chest pain
|
4.1%
2/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Fatigue
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Malaise
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Pyrexia
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
General physical health deterioration
|
4.1%
2/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Cellulitis
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Infection
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Sepsis
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/49 • Number of events 3
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Investigations
Haemoglobin decreased
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Loss of consciousness
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Sciatica
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Syncope
|
4.1%
2/49 • Number of events 3
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Renal and urinary disorders
Renal failure
|
8.2%
4/49 • Number of events 7
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.1%
2/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.0%
1/49 • Number of events 2
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Surgical and medical procedures
Tumour excision
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Vascular disorders
Circulatory collapse
|
2.0%
1/49 • Number of events 1
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
Other adverse events
| Measure |
Regorafenib (BAY73-4506)
n=49 participants at risk
Subjects received regorafenib 160 mg po qd for 3 weeks of every 4 week cycle (3 weeks on, 1 week off).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.2%
5/49 • Number of events 9
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.2%
5/49 • Number of events 11
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Abdominal pain
|
26.5%
13/49 • Number of events 37
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.3%
8/49 • Number of events 28
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Constipation
|
34.7%
17/49 • Number of events 112
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Diarrhoea
|
49.0%
24/49 • Number of events 215
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Dyspepsia
|
12.2%
6/49 • Number of events 7
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Dysphagia
|
8.2%
4/49 • Number of events 5
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Glossodynia
|
6.1%
3/49 • Number of events 4
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Nausea
|
32.7%
16/49 • Number of events 46
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Oral pain
|
12.2%
6/49 • Number of events 35
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Stomatitis
|
30.6%
15/49 • Number of events 108
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Gastrointestinal disorders
Vomiting
|
26.5%
13/49 • Number of events 29
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Chest pain
|
14.3%
7/49 • Number of events 19
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Chills
|
6.1%
3/49 • Number of events 6
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Fatigue
|
44.9%
22/49 • Number of events 192
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Mucosal inflammation
|
12.2%
6/49 • Number of events 11
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Oedema peripheral
|
8.2%
4/49 • Number of events 13
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Pain
|
12.2%
6/49 • Number of events 31
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
General disorders
Pyrexia
|
18.4%
9/49 • Number of events 14
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Bronchitis
|
6.1%
3/49 • Number of events 3
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Infection
|
6.1%
3/49 • Number of events 3
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Nasopharyngitis
|
18.4%
9/49 • Number of events 21
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Oral candidiasis
|
6.1%
3/49 • Number of events 7
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Rhinitis
|
8.2%
4/49 • Number of events 6
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
4/49 • Number of events 6
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Infections and infestations
Urinary tract infection
|
12.2%
6/49 • Number of events 13
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Investigations
Amylase increased
|
8.2%
4/49 • Number of events 12
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Investigations
Blood creatinine increased
|
6.1%
3/49 • Number of events 7
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Investigations
Lipase increased
|
14.3%
7/49 • Number of events 29
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Investigations
Weight decreased
|
16.3%
8/49 • Number of events 86
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.1%
3/49 • Number of events 13
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.7%
16/49 • Number of events 104
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
7/49 • Number of events 120
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.5%
13/49 • Number of events 55
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.1%
3/49 • Number of events 25
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.2%
6/49 • Number of events 53
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.3%
8/49 • Number of events 23
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.2%
4/49 • Number of events 12
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.4%
11/49 • Number of events 85
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Ageusia
|
6.1%
3/49 • Number of events 4
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Dizziness
|
8.2%
4/49 • Number of events 7
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Dysgeusia
|
8.2%
4/49 • Number of events 14
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Headache
|
28.6%
14/49 • Number of events 47
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Neuropathy peripheral
|
8.2%
4/49 • Number of events 8
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Nervous system disorders
Paraesthesia
|
8.2%
4/49 • Number of events 61
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Psychiatric disorders
Insomnia
|
12.2%
6/49 • Number of events 23
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
6/49 • Number of events 15
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
36.7%
18/49 • Number of events 50
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
32.7%
16/49 • Number of events 48
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.2%
4/49 • Number of events 6
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
3/49 • Number of events 7
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.9%
22/49 • Number of events 139
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.2%
6/49 • Number of events 77
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.2%
5/49 • Number of events 19
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.2%
4/49 • Number of events 8
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
6.1%
3/49 • Number of events 3
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
69.4%
34/49 • Number of events 402
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.2%
5/49 • Number of events 16
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Rash
|
34.7%
17/49 • Number of events 74
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
6.1%
3/49 • Number of events 4
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
|
Vascular disorders
Hypertension
|
51.0%
25/49 • Number of events 338
Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The agreed point of publication is 12-18 months after database lock at the earliest. Bayer will have 30-45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable). No publication of single center data should be done prior of publication if multi-center data.
- Publication restrictions are in place
Restriction type: OTHER