Trial Outcomes & Findings for A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma (NCT NCT00108953)
NCT ID: NCT00108953
Last Updated: 2014-10-31
Results Overview
TTP was defined as the time from randomization to radiological disease progression by independent assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
from date of randomization of the first patient until 3 years later
Results posted on
2014-10-31
Participant Flow
Enrollment started on 13 Apr 2005 and the last study contact occurred on 11 Apr 2008. The study was conducted at 25 active centers in 6 countries (Argentina, Canada, Hong Kong, Russia, United Kingdom, and United States.)
140 patients were screened, with 44 screen failures. The intent-to-treat (ITT) population (primary efficacy analysis) includes all randomized patients (96). The Safety population includes all patients who received at least 1 dose of study drug (95). The study consists of 2 periods: treatment period (not fixed but ended by any event) and follow-up.
Participant milestones
| Measure |
Sorafenib + Doxorubicin
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Treatment Period
STARTED
|
47
|
49
|
|
Treatment Period
COMPLETED
|
47
|
49
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
|
Follow-up
STARTED
|
40
|
45
|
|
Follow-up
COMPLETED
|
11
|
12
|
|
Follow-up
NOT COMPLETED
|
29
|
33
|
Reasons for withdrawal
| Measure |
Sorafenib + Doxorubicin
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Follow-up
Death
|
18
|
26
|
|
Follow-up
Lost to Follow-up
|
1
|
1
|
|
Follow-up
Study terminated by sponsor
|
10
|
6
|
Baseline Characteristics
A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Median (Full Range)
|
66 years
n=5 Participants
|
65 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Child Pugh Status
5 (Child-Pugh A)
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Child Pugh Status
6 (Child-Pugh A)
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Child Pugh Status
7 (Child-Pugh B)
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Child Pugh Status
>7
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Group performance status (ECOG PS) at study entry
Grade 0
|
22 participants
n=5 Participants
|
16 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Eastern Cooperative Group performance status (ECOG PS) at study entry
Grade 1
|
18 participants
n=5 Participants
|
25 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Eastern Cooperative Group performance status (ECOG PS) at study entry
Grade 2
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Eastern Cooperative Group performance status (ECOG PS) at study entry
Grade 3
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Eastern Cooperative Group performance status (ECOG PS) at study entry
missing
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Tumor burden: Extrahepatic spread
yes
|
24 participants
n=5 Participants
|
32 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Tumor burden: Extrahepatic spread
no
|
23 participants
n=5 Participants
|
17 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Tumor burden: Macroscopic vascular invasion
yes
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Tumor burden: Macroscopic vascular invasion
no
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Tumor burden: Macroscopic vascular invasion
missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from date of randomization of the first patient until 3 years laterPopulation: The intent-to-treat (ITT) population, primary population for efficacy analysis, includes all randomized patients.
TTP was defined as the time from randomization to radiological disease progression by independent assessment.
Outcome measures
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Time to Progression (TTP)
|
263 days
Interval 146.0 to 384.0
|
147 days
Interval 66.0 to 244.0
|
SECONDARY outcome
Timeframe: from date of randomization of the first patient until 3 years laterPopulation: The ITT population, primary population for efficacy analysis, includes all randomized patients. The table below gives the lower and upper limit of the confidence interval; 999999999 = not estimable.
The time from date of randomization to date of death
Outcome measures
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Overall Survival
|
418 days
Interval 317.0 to 999999999.0
|
199 days
Interval 148.0 to 302.0
|
SECONDARY outcome
Timeframe: from date of randomization of the first patient until 3 years laterPopulation: The ITT population, primary population for efficacy analysis, includes all randomized patients.
Time from the date of randomization to the date of the first documented radiological progression (as defined per independent central radiological assessment) or death, whichever occurs first
Outcome measures
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Progression Free Survival (PFS)
|
242 days
Interval 140.0 to 312.0
|
85 days
Interval 71.0 to 172.0
|
SECONDARY outcome
Timeframe: achieved during treatment or within 30 days after termination of active therapyPopulation: The ITT population, primary population for efficacy analysis, includes all randomized patients.
Percentage of participants with complete or partial response (CR or PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) and achieved during treatment or 30 days after end of treatment. CR: disappearance of all clinical and radiological tumor lesions. PR: at least 30% decrease in sum of the longest diameters of tumor lesions. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
Outcome measures
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Percentage of Participants in Each Category of Best Tumor Response
Complete Response (CR)
|
0.0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants in Each Category of Best Tumor Response
Partial Response (PR)
|
4.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Category of Best Tumor Response
Stable Disease (SD)
|
66.0 Percentage of participants
|
49.0 Percentage of participants
|
SECONDARY outcome
Timeframe: from date of randomization of the first patient until 3 years laterPopulation: The ITT population, primary population for efficacy analysis, includes all randomized patients.
Time from date of randomization to date of first documented symptomatic progression defined by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8) assessment
Outcome measures
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Time to Symptomatic Progression (TTSP)
|
208 days
Interval 85.0 to 317.0
|
152 days
Interval 110.0 to 180.0
|
SECONDARY outcome
Timeframe: from date of randomization of the first patient until 3 years laterPopulation: The ITT population, primary population for efficacy analysis, includes all randomized patients.
Time from date of first objective response (complete response \[CR\] or partial response \[PR\]) to date progression is first documented (as defined per independent central radiological assessment) or death, whichever occurs first
Outcome measures
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Duration of Response
|
199 days
Interval 97.0 to 301.0
|
68 days
Interval 68.0 to 68.0
|
SECONDARY outcome
Timeframe: from date of randomization until 3 years later at end of studyPopulation: The ITT population, primary population for efficacy analysis, includes all randomized patients.
Time from date of randomization to date of first objective response (complete response \[CR\] or partial response \[PR\]) is documented and confirmed according to RECIST criteria
Outcome measures
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Time to Response (TTR)
|
134 days
Interval 83.0 to 184.0
|
40 days
Interval 40.0 to 40.0
|
SECONDARY outcome
Timeframe: from date of randomization to end of treatment plus 30 daysPopulation: The ITT population, primary population for efficacy analysis, includes all randomized patients.
Participants with disease control: those who have as best response complete response (CR), partial response (PR) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease) according to Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome measures
| Measure |
Sorafenib + Doxorubicin
n=47 Participants
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=49 Participants
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Percentage of Participants for Whom Disease Control Was Achieved
|
63.8 Percentage of participants
|
30.6 Percentage of participants
|
Adverse Events
Sorafenib + Doxorubicin
Serious events: 19 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo + Doxorubicin
Serious events: 20 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib + Doxorubicin
n=47 participants at risk
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=48 participants at risk
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Cardiac disorders
Supraventricular Arrhythmia, Atrial Fibrillation
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Cardiac disorders
Supraventricular Arrhythmia, Sinus Tachycardia
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Cardiac disorders
Hypotension
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Death not associated with CTCAE term, Disease Progression NOS
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
20.8%
10/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Fever
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Fatigue
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Dehydration
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
4.2%
2/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
4.2%
2/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam), Oral Cavity
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Ileus
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Vascular disorders
Hemorrhage, GI, Stomach
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Vascular disorders
Hemorrhage, GI, Upper GI NOS
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Hepatobiliary disorders
Liver Dysfunction
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Hepatobiliary disorders
Hepathobilary - other
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Febrile Neutropenia
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
10.4%
5/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Infection with normal ANC, Skin (Cellulitis)
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Infection (Documented Clinically), Blood
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Infection (Documented Clinically), Kidney
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Infection (Documented Clinically), Lung (Pneumonia)
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Infection (Documented Clinically), Skin (Cellulitis)
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Infection with normal ANC, Soft Tissue NOS
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Lipase
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Bilirubin (Hyperbilirubinemia)
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Nervous system disorders
Neurology - other
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Back
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Abdomen NOS
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Chest/Thorax NOS
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Liver
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness of Breath)
|
4.3%
2/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
2.1%
1/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Vascular disorders
Artery Injury, Visceral
|
2.1%
1/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
Other adverse events
| Measure |
Sorafenib + Doxorubicin
n=47 participants at risk
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
Placebo + Doxorubicin
n=48 participants at risk
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
66.0%
31/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
60.4%
29/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Blood and lymphatic system disorders
Hemoglobin
|
31.9%
15/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
31.2%
15/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Blood and lymphatic system disorders
Leukocytes
|
21.3%
10/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
18.8%
9/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Fatigue
|
83.0%
39/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
66.7%
32/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Insomnia
|
27.7%
13/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
16.7%
8/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Nausea
|
57.4%
27/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
56.2%
27/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Constipation
|
44.7%
21/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
43.8%
21/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Anorexia
|
51.1%
24/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
29.2%
14/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Diarrhea
|
53.2%
25/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
25.0%
12/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Mucositis (Functional/Symptomatic), Oral Cavity
|
23.4%
11/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
29.2%
14/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
GI - other
|
27.7%
13/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
14.6%
7/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam), Oral Cavity
|
21.3%
10/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
12.5%
6/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Taste Alteration
|
21.3%
10/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
10.4%
5/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Blood and lymphatic system disorders
Edema: Limb
|
31.9%
15/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
29.2%
14/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Bilirubin (Hyperbilirubinemia)
|
31.9%
15/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
31.2%
15/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
AST
|
23.4%
11/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
14.6%
7/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Nervous system disorders
Dizziness
|
21.3%
10/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Abdomen NOS
|
38.3%
18/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
31.2%
15/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Back
|
29.8%
14/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
14.6%
7/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.7%
13/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
18.8%
9/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.1%
24/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
52.1%
25/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
38.3%
18/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
16.7%
8/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
29.8%
14/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
21.3%
10/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Vomiting
|
36.2%
17/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
20.8%
10/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Immune system disorders
Rhinits
|
8.5%
4/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
10.4%
5/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Blood and lymphatic system disorders
Blood Other
|
12.8%
6/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
14.6%
7/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Blood and lymphatic system disorders
Platelets
|
14.9%
7/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
18.8%
9/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Blood and lymphatic system disorders
INR
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Cardiac disorders
Supraventricular Arrhythmia, Sinus Tachycardia
|
8.5%
4/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Cardiac disorders
Hypertension
|
17.0%
8/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Cardiac disorders
Hypotension
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
19.1%
9/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Fever
|
8.5%
4/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Weight Loss
|
19.1%
9/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
14.6%
7/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Constitutional Symptoms- Other
|
14.9%
7/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Rigors/Chills
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Sweating
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Ascites
|
8.5%
4/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
12.5%
6/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Distention
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
12.5%
6/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Dry Mouth
|
8.5%
4/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Dysphagia
|
14.9%
7/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Flatulence
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Heartburn
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Teeth
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Vascular disorders
Hemorrhage, GI, Oral Cavity
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Vascular disorders
Hemorrhage Pulmonary, Nose
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Gastrointestinal disorders
Liver Dysfunction
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Infection(Documented Clinically), Oral cavity - gums
|
12.8%
6/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Infections and infestations
Infection- Other
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal- Other
|
17.0%
8/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
14.6%
7/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
ALT
|
17.0%
8/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Metabolism and nutrition disorders
Metabolic/Lab- Other
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
10.4%
5/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Nervous system disorders
Mood Alteration, Anxiety
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Nervous system disorders
Mood Alteration, Depression
|
8.5%
4/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Nervous system disorders
Neuropathy: sensory
|
14.9%
7/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Eye disorders
Ocular- Other
|
8.5%
4/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Eye disorders
Watery Eye
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Chest Wall
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Extremity-Limb
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Head/Headache
|
19.1%
9/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
12.5%
6/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Joint
|
19.1%
9/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Muscle
|
12.8%
6/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Other
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Liver
|
12.8%
6/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Middle Ear
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Pain NOS
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Stomach
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
General disorders
Pain, Throat/Pharynx/Larynx
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
0.00%
0/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
8.3%
4/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary- Other
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea(Shortness of Breath)
|
17.0%
8/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
16.7%
8/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Bruising
|
12.8%
6/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.6%
5/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Dermatology- Other
|
17.0%
8/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
12.5%
6/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.1%
9/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
6.2%
3/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
|
Skin and subcutaneous tissue disorders
Flushing
|
6.4%
3/47
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
0.00%
0/48
The following abbreviations were used in the Adverse Event section: * Common toxicity criteria for adverse events (CTCAE) * Absolute neutrophil count (ANC) * Alanine aminotransferase (AST) * Gastrointestinal (GI) * Not otherwise specified (NOS) * International normalized ratio (INR) * Alanine aminotransferase (ALT)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The institution of the Coordinating Investigator (CI) has the right, consistent with academic standards, to publish any proposed publication written by the consultant as part of their services under this agreement. If the sponsor believes that any proposed publication contained any confidential information, the sponsor shall notify the CI, and the CI shall remove such confidential information.
- Publication restrictions are in place
Restriction type: OTHER