Trial Outcomes & Findings for Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer (NCT NCT00881751)
NCT ID: NCT00881751
Last Updated: 2017-09-11
Results Overview
Overall survival is defined as the time from treatment day 1 until death from any cause. Patients still alive at the end of follow up,patients who withdrew consent from the trial and patients who were lost to follow up will have their survival time censored at the last date of contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
from date of day 1 until the date of death
Results posted on
2017-09-11
Participant Flow
Participant milestones
| Measure |
Arm I
Subjects who were enrolled to the Bevacizumab + Erlotinib Arm.
Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle
|
Arm II
Subjects who were enrolled to the sorafenib arm.
Sorafenib: oral administration on days 1-28 of a 28 day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
COMPLETED
|
47
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Arm I
Subjects who were enrolled to the Bevacizumab + Erlotinib Arm.
Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle
|
Arm II
Subjects who were enrolled to the sorafenib arm.
Sorafenib: oral administration on days 1-28 of a 28 day cycle
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=47 Participants
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.
bevacizumab: Given IV
erlotinib hydrochloride: Given orally
|
Arm II
n=48 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-28.
sorafenib tosylate: Given orally
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from date of day 1 until the date of deathPopulation: Only subjects who received one dose of study drug were considered for this outcome. 5 subjects enrolled to Arm II did not receive any study drug and were not evaluable for this outcome.
Overall survival is defined as the time from treatment day 1 until death from any cause. Patients still alive at the end of follow up,patients who withdrew consent from the trial and patients who were lost to follow up will have their survival time censored at the last date of contact.
Outcome measures
| Measure |
Arm I
n=47 Participants
Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.
Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle
|
Arm II
n=43 Participants
Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.
Sorafenib: oral administration on days 1-28 of a 28 day cycle
|
|---|---|---|
|
Overall Survival
|
8.55 Months
Interval 7.0 to 13.9
|
8.55 Months
Interval 5.69 to 12.2
|
SECONDARY outcome
Timeframe: From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study.EFS is defined as the time from randomization to any of the following three types of events: 1 - progression; 2 - withdrawal due to excessive toxicity; 3 - any other clinical event requiring withdrawal from the study.
Outcome measures
| Measure |
Arm I
n=47 Participants
Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.
Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle
|
Arm II
n=43 Participants
Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.
Sorafenib: oral administration on days 1-28 of a 28 day cycle
|
|---|---|---|
|
Event-free Survival
|
4.37 Months
Interval 2.99 to 7.36
|
2.76 Months
Interval 1.84 to 4.8
|
SECONDARY outcome
Timeframe: From day 1 of drug administration until 30 days after the last dose of study drug.Population: Patients who received at least one dose of study drug were included in this analysis.
The study will report the number of SAEs experienced in each arm. All patients who receive any study drug will be evaluable for toxicity.
Outcome measures
| Measure |
Arm I
n=47 Participants
Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.
Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle
|
Arm II
n=43 Participants
Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.
Sorafenib: oral administration on days 1-28 of a 28 day cycle
|
|---|---|---|
|
Number of SAEs Experienced
|
48 serious adverse events
|
39 serious adverse events
|
SECONDARY outcome
Timeframe: From day 1 drug administration until 30 days after the last dose of study drug.Population: Responders include complete and partial responders defined by RECIST 1.1 criteria.
Secondary outcome measures include response rate as assessed on restaging imaging studies utilizing RECIST 1.1.
Outcome measures
| Measure |
Arm I
n=47 Participants
Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.
Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle
|
Arm II
n=43 Participants
Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.
Sorafenib: oral administration on days 1-28 of a 28 day cycle
|
|---|---|---|
|
Response Rate
|
15 percentage of participants
|
9 percentage of participants
|
Adverse Events
Arm I
Serious events: 25 serious events
Other events: 47 other events
Deaths: 0 deaths
Arm II
Serious events: 19 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=47 participants at risk
Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.
Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle
|
Arm II
n=43 participants at risk
Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.
Sorafenib: oral administration on days 1-28 of a 28 day cycle
|
|---|---|---|
|
Cardiac disorders
cardiac arest
|
4.3%
2/47 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
atrial fibrillation
|
4.3%
2/47 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
hypotension
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
tachycardia
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
hypertension
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
acute coronary syndrome
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
4.3%
2/47 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.1%
1/47 • Number of events 3 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Hepatobiliary disorders
hepatic failure
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Hepatobiliary disorders
pancreatitis
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
esophageal varices hemorrhage
|
4.3%
2/47 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
duodenal hemorrhage
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
hemorrhagic stroke
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
GI hemorrhage
|
6.4%
3/47 • Number of events 3 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
esophageal hemorrhage
|
2.1%
1/47 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
melena
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Infections and infestations
septic arthritis
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Infections and infestations
osteomyelitis
|
4.3%
2/47 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Infections and infestations
subdiaphragmatic abscess
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Infections and infestations
pneumonia
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Infections and infestations
urosepsis
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
encephalopathy
|
6.4%
3/47 • Number of events 4 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • Number of events 3 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
altered mental status
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • Number of events 3 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
confusion
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
syncope
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
seizure
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
creatinine
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypoglycemia
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
rash (zoster)
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
ascites
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
anorexia
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
dysphagia
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
dehydration
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
esophageal varices
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
abdominal pain
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 2 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
arm pain
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Vascular disorders
thromboembolic event
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Renal and urinary disorders
acute renal failure
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
fever
|
2.1%
1/47 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
fatigue
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Blood and lymphatic system disorders
hemoglobin
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • Number of events 3 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
lower extremity edema
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • Number of events 1 • From initiation of study drug administration until 30 days after last study drug administration
|
Other adverse events
| Measure |
Arm I
n=47 participants at risk
Subjects who were enrolled to the Bevacizumab + Erlotinib Arm and received at least one dose of study drug.
Bevacizumab: IV on days 1 and 15 of a 28 day cycle Erlotinib: Oral on days 1-28 of a 28 day cycle
|
Arm II
n=43 participants at risk
Subjects who were enrolled to the sorafenib arm and received at least one dose of study drug.
Sorafenib: oral administration on days 1-28 of a 28 day cycle
|
|---|---|---|
|
Ear and labyrinth disorders
tinnitus
|
4.3%
2/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Blood and lymphatic system disorders
hemoglobin
|
42.6%
20/47 • From initiation of study drug administration until 30 days after last study drug administration
|
30.2%
13/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Investigations
neutrophils (NOS)
|
12.8%
6/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Blood and lymphatic system disorders
platelets
|
38.3%
18/47 • From initiation of study drug administration until 30 days after last study drug administration
|
39.5%
17/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Blood and lymphatic system disorders
RBC decrease
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Blood and lymphatic system disorders
WBC decrease
|
14.9%
7/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Blood and lymphatic system disorders
WBC increase
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
hypotension
|
8.5%
4/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
tachycardia
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Cardiac disorders
hypertension
|
42.6%
20/47 • From initiation of study drug administration until 30 days after last study drug administration
|
32.6%
14/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Investigations
INR
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
chills
|
29.8%
14/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
dizziness
|
10.6%
5/47 • From initiation of study drug administration until 30 days after last study drug administration
|
27.9%
12/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
fatigue
|
70.2%
33/47 • From initiation of study drug administration until 30 days after last study drug administration
|
76.7%
33/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
fever
|
31.9%
15/47 • From initiation of study drug administration until 30 days after last study drug administration
|
11.6%
5/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
headache
|
14.9%
7/47 • From initiation of study drug administration until 30 days after last study drug administration
|
14.0%
6/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
hemorrhage (NOS)
|
8.5%
4/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
insomnia
|
21.3%
10/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
sweating
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
weight loss
|
53.2%
25/47 • From initiation of study drug administration until 30 days after last study drug administration
|
39.5%
17/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
weight gain
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
acne
|
57.4%
27/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
alopecia
|
27.7%
13/47 • From initiation of study drug administration until 30 days after last study drug administration
|
20.9%
9/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
blisters
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
bruising
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
dry skin
|
51.1%
24/47 • From initiation of study drug administration until 30 days after last study drug administration
|
39.5%
17/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
erythema multiforme
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
14.0%
6/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
hand-foot skin reaction
|
10.6%
5/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
nail changes
|
21.3%
10/47 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
nail loss
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
petechiae
|
8.5%
4/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
pruritus
|
53.2%
25/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
rash
|
34.0%
16/47 • From initiation of study drug administration until 30 days after last study drug administration
|
25.6%
11/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
skin pain
|
4.3%
2/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
skin peeling
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
skin redness
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
abdominal pain
|
51.1%
24/47 • From initiation of study drug administration until 30 days after last study drug administration
|
23.3%
10/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
anorexia
|
61.7%
29/47 • From initiation of study drug administration until 30 days after last study drug administration
|
44.2%
19/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
ascites
|
19.1%
9/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
bloating
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
constipation
|
12.8%
6/47 • From initiation of study drug administration until 30 days after last study drug administration
|
25.6%
11/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
dehydration
|
25.5%
12/47 • From initiation of study drug administration until 30 days after last study drug administration
|
11.6%
5/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
diarrhea
|
66.0%
31/47 • From initiation of study drug administration until 30 days after last study drug administration
|
76.7%
33/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
discolored stool
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
distension
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
dry mouth
|
31.9%
15/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
dysgeusia
|
44.7%
21/47 • From initiation of study drug administration until 30 days after last study drug administration
|
20.9%
9/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
dyspepsia
|
23.4%
11/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
dysphagia
|
12.8%
6/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
flatulence
|
17.0%
8/47 • From initiation of study drug administration until 30 days after last study drug administration
|
11.6%
5/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
hemorrhoids
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
mucositis/stomatitis (NOS)
|
27.7%
13/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
nausea
|
51.1%
24/47 • From initiation of study drug administration until 30 days after last study drug administration
|
41.9%
18/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
stomach pain
|
4.3%
2/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Gastrointestinal disorders
vomiting
|
25.5%
12/47 • From initiation of study drug administration until 30 days after last study drug administration
|
39.5%
17/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Hepatobiliary disorders
encephalopathy
|
8.5%
4/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Hepatobiliary disorders
jaundice
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
edema (NOS)
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
edema: limb
|
14.9%
7/47 • From initiation of study drug administration until 30 days after last study drug administration
|
32.6%
14/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
edema: trunk
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
albumin (NOS)
|
8.5%
4/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
alkaline phosphatase
|
38.3%
18/47 • From initiation of study drug administration until 30 days after last study drug administration
|
23.3%
10/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
ALT
|
36.2%
17/47 • From initiation of study drug administration until 30 days after last study drug administration
|
25.6%
11/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
AST
|
53.2%
25/47 • From initiation of study drug administration until 30 days after last study drug administration
|
30.2%
13/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
bicarbonate decrease
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
bilirubin
|
44.7%
21/47 • From initiation of study drug administration until 30 days after last study drug administration
|
30.2%
13/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
BUN increase
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
calcium (NOS)
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
creatinine increase
|
12.8%
6/47 • From initiation of study drug administration until 30 days after last study drug administration
|
11.6%
5/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
Creatinine (NOS)
|
8.5%
4/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
glucose (NOS)
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hyperammonemia
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hyperglycemia
|
17.0%
8/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hyperkalemia
|
12.8%
6/47 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypernatremia
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
29.8%
14/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypocalcemia
|
19.1%
9/47 • From initiation of study drug administration until 30 days after last study drug administration
|
18.6%
8/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypoglycemia
|
4.3%
2/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypokalemia
|
23.4%
11/47 • From initiation of study drug administration until 30 days after last study drug administration
|
11.6%
5/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
17.0%
8/47 • From initiation of study drug administration until 30 days after last study drug administration
|
14.0%
6/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hyponatremia
|
31.9%
15/47 • From initiation of study drug administration until 30 days after last study drug administration
|
27.9%
12/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
19.1%
9/47 • From initiation of study drug administration until 30 days after last study drug administration
|
18.6%
8/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
magnesium (NOS)
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
phosphorus (NOS)
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Metabolism and nutrition disorders
potassium (NOS)
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
back pain
|
23.4%
11/47 • From initiation of study drug administration until 30 days after last study drug administration
|
23.3%
10/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
body ache
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
8.5%
4/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
extremity cramping
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
extremity pain
|
4.3%
2/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
17.0%
8/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
muscle cramping
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
19.1%
9/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Musculoskeletal and connective tissue disorders
weakness
|
10.6%
5/47 • From initiation of study drug administration until 30 days after last study drug administration
|
32.6%
14/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Psychiatric disorders
altered mental status
|
4.3%
2/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Psychiatric disorders
anxiety
|
10.6%
5/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
ataxia
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Psychiatric disorders
confusion
|
10.6%
5/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Psychiatric disorders
depression
|
14.9%
7/47 • From initiation of study drug administration until 30 days after last study drug administration
|
14.0%
6/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
memory impairment
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
sensory neuropathy
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
syncope
|
0.00%
0/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Nervous system disorders
voice changes
|
23.4%
11/47 • From initiation of study drug administration until 30 days after last study drug administration
|
14.0%
6/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Eye disorders
blurred vision
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Eye disorders
dry eye
|
19.1%
9/47 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
29.8%
14/47 • From initiation of study drug administration until 30 days after last study drug administration
|
14.0%
6/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
29.8%
14/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Renal and urinary disorders
dysuria
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Renal and urinary disorders
hematuria
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
0.00%
0/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Renal and urinary disorders
proteinuria
|
29.8%
14/47 • From initiation of study drug administration until 30 days after last study drug administration
|
16.3%
7/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Renal and urinary disorders
urinary frequency/urgency
|
17.0%
8/47 • From initiation of study drug administration until 30 days after last study drug administration
|
2.3%
1/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Renal and urinary disorders
urinary tract infection
|
8.5%
4/47 • From initiation of study drug administration until 30 days after last study drug administration
|
9.3%
4/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
2.1%
1/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
46.8%
22/47 • From initiation of study drug administration until 30 days after last study drug administration
|
7.0%
3/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
General disorders
flu-like syndrome
|
14.9%
7/47 • From initiation of study drug administration until 30 days after last study drug administration
|
4.7%
2/43 • From initiation of study drug administration until 30 days after last study drug administration
|
|
Skin and subcutaneous tissue disorders
hand-foot syndrome
|
6.4%
3/47 • From initiation of study drug administration until 30 days after last study drug administration
|
20.9%
9/43 • From initiation of study drug administration until 30 days after last study drug administration
|
Additional Information
Kate Anderton, MPH, CCRP
Medical University of South Carolina
Phone: [email protected]
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place