Trial Outcomes & Findings for Long-term Extension From RCC Phase II (11515) (NCT NCT00586495)
NCT ID: NCT00586495
Last Updated: 2013-12-13
Results Overview
Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Results posted on
2013-12-13
Participant Flow
This was an extension study of Study 11515 (NCT00661375), in which the first subject was enrolled on 10 Nov 2004. This extension study was started in December 2005, and the last subject completed the study on 11 Jul 2008. The study was conducted in 41 centers in Japan.
95 subjects were enrolled in this extension study; 95 were valid for the safety analysis and 94 were valid for the intent-to treat (ITT) analysis. 92 subjects entered Follow-up period which started 30 days after last dose. 3 subjects did not enter the Follow-up period because they died within 30 days after last dose.
Participant milestones
| Measure |
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Treatment Period
STARTED
|
95
|
|
Treatment Period
COMPLETED
|
0
|
|
Treatment Period
NOT COMPLETED
|
95
|
|
Follow-up
STARTED
|
92
|
|
Follow-up
COMPLETED
|
0
|
|
Follow-up
NOT COMPLETED
|
92
|
Reasons for withdrawal
| Measure |
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Treatment Period
Adverse Event
|
11
|
|
Treatment Period
Death
|
1
|
|
Treatment Period
Protocol Violation
|
1
|
|
Treatment Period
Withdrawal by Subject
|
1
|
|
Treatment Period
Disease progression, recurrence/relapse
|
71
|
|
Treatment Period
Switch to commercial drug
|
10
|
|
Follow-up
Death
|
40
|
|
Follow-up
Lost to Follow-up
|
1
|
|
Follow-up
Withdrawal by Subject
|
4
|
|
Follow-up
Protocol driven decision point
|
37
|
|
Follow-up
Switch to commercial drug
|
10
|
Baseline Characteristics
Long-term Extension From RCC Phase II (11515)
Baseline characteristics by cohort
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=95 Participants
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Age Continuous
|
62.0 years
STANDARD_DEVIATION 10.5 • n=93 Participants
|
|
Age, Customized
<65 years
|
54 participants
n=93 Participants
|
|
Age, Customized
>=65 years
|
41 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
80 participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
15 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeksPopulation: Intention to treat (ITT) population.
Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=94 Participants
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Progression Free Survival (PFS)
|
386 days
Interval 274.0 to 502.0
|
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeksPopulation: ITT population
Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=94 Participants
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Best Tumor Response
Complete Response (CR)
|
0 participants
|
|
Best Tumor Response
Partial Response (PR)
|
25 participants
|
|
Best Tumor Response
Stable Disease (SD)
|
64 participants
|
|
Best Tumor Response
Disease Progression (radiological or clinical)
|
4 participants
|
|
Best Tumor Response
Not evaluated
|
1 participants
|
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 3 monthsPopulation: ITT population. The median overall survival (OS) and the lower limit of 95% Confidence interval were not estimable because more than half (n=51) of the study population were censored. The number of participant who died is shown in "Post-Hoc Outcome Measure: Number of Participants who Died".
Time from initiation of treatment to death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeksPopulation: ITT population.
Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=94 Participants
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Overall Response Duration
|
419 days
Interval 238.0 to 862.0
|
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeksPopulation: ITT population.
Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=94 Participants
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Time to Objective Response
|
84 days
Interval 35.0 to 558.0
|
SECONDARY outcome
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeksPopulation: ITT population.
Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=94 Participants
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Overall Disease Control
|
81 participants
|
POST_HOC outcome
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 3 monthsPopulation: "Overall Survival" is shown in "Secondary Outcome Measure: Overall Survival".
Number of subjects who died due to any cause.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=94 Participants
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Number of Participants Who Died
|
43 participants
|
Adverse Events
Sorafenib (Nexavar, BAY43-9006)
Serious events: 34 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=95 participants at risk
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Leukocytes
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Platelets
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Cardiac disorders
Prolonged QTC
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Cardiac disorders
Hypertension
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Constitutional symptoms - other
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Fever
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Death not associated with CTCAE term, death NOS
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Death not associated with CTCAE term, disease progression NOS
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Anorexia
|
3.2%
3/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Dehydration
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Distension
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
GI - other
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Ileus
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Nausea
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Ulcer, GI, duodeum
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Vascular disorders
Hemorrhage pulmonary, bronchus
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Vascular disorders
Hemorrhage, GI, colon
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Vascular disorders
Hemorrhage, GI, duodenum
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Hepatobiliary disorders
Cholecystitis
|
3.2%
3/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Hepatobiliary disorders
Liver dysfunction
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Infections and infestations
Infection - other
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Infections and infestations
Infection with normal ANC, bronchus
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Infections and infestations
Infection with normal ANC, lung (pneumonia)
|
3.2%
3/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Infections and infestations
Infection with normal ANC, upper airway NOS
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Edema: limb
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Lymphatics - other
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
ALT
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Amylase
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
AST
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
CPK
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
GGT
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Lipase
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Metabolic/lab - other
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Proteinuria
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Nervous system disorders
Dizziness
|
2.1%
2/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Nervous system disorders
Somnolence
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Eye disorders
Cataract
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
No code in CTCAE
|
3.2%
3/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, abdomen NOS
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, tumor pain
|
4.2%
4/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - other
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Syndromes - other
|
1.1%
1/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
Other adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=95 participants at risk
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
|
|---|---|
|
Immune system disorders
Allergic reaction
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Ear and labyrinth disorders
Auditory/ear - other
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Blood - other
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Hemoglobin
|
14.7%
14/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Leukocytes
|
7.4%
7/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.4%
8/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Cardiac disorders
Hypertension
|
43.2%
41/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Fatigue
|
32.6%
31/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Fever
|
20.0%
19/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Hypothermia
|
7.4%
7/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Insomnia
|
8.4%
8/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Rigors/chills
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Weight loss
|
29.5%
28/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.5%
48/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Skin and subcutaneous tissue disorders
Dermatology - other
|
15.8%
15/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
64.2%
61/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
19/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
56.8%
54/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Endocrine disorders
Hot flashes
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Anorexia
|
28.4%
27/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Constipation
|
18.9%
18/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Diarrhea
|
61.1%
58/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Distension
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
GI - other
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Heartburn
|
9.5%
9/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Mucositis (clinical exam), oral cavity
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic), oral cavity
|
8.4%
8/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Nausea
|
15.8%
15/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Periodontal
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Gastrointestinal disorders
Vomiting
|
16.8%
16/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Vascular disorders
Hemorrhage pulmonary, bronchopulmonary NOS
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Vascular disorders
Hemorrhage pulmonary, nose
|
7.4%
7/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Infections and infestations
Infection - other
|
12.6%
12/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Infections and infestations
Infection with normal ANC, Bronchus
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Infections and infestations
Infection with normal ANC, Lung (Pneumonia)
|
12.6%
12/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
7.4%
7/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Blood and lymphatic system disorders
Edema: limb
|
16.8%
16/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
15.8%
15/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
ALT
|
24.2%
23/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Amylase
|
45.3%
43/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
AST
|
25.3%
24/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Creatinine
|
8.4%
8/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
GGT
|
7.4%
7/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
15.8%
15/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.6%
11/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Lipase
|
65.3%
62/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Metabolic/lab - other
|
40.0%
38/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Metabolism and nutrition disorders
Proteinuria
|
12.6%
12/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - other
|
12.6%
12/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Nervous system disorders
Dizziness
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Nervous system disorders
Neuropathy - sensory
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Eye disorders
Ocular surface disease
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, abdomen NOS
|
11.6%
11/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, back
|
24.2%
23/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, chest/thorax NOS
|
10.5%
10/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, dental/teeth/peridontal
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, extremity/limb
|
13.7%
13/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, head/headache
|
18.9%
18/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, joint
|
16.8%
16/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, other
|
8.4%
8/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, stomach
|
6.3%
6/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, throat/pharynx/larynx
|
10.5%
10/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Pain, tumor pain
|
15.8%
15/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.1%
21/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.4%
8/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - other
|
5.3%
5/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
18.9%
18/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
|
General disorders
Flu-like syndrome
|
35.8%
34/95
Acronyms used in Adverse Event section: Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Common Terminology Criteria for Adverse Events (CTCAE), Creatine Phosphokinase (CPK), Gamma-Glutamyl Transpeptidase (GGT), Gastro-Intestinal (GI), Not Otherwise Specified (NOS).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60