Trial Outcomes & Findings for Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE) (NCT NCT00494299)
NCT ID: NCT00494299
Last Updated: 2013-12-20
Results Overview
Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
458 participants
Primary outcome timeframe
From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.
Results posted on
2013-12-20
Participant Flow
The first subject was enrolled on 27 Aug 2006. The final data collection date for the primary endpoint analysis was 10 Jul 2009. The study was conducted at 77 centers from 2 countries: Korea (7 centers) and Japan (70). 76 centers enrolled at least 1 subject (7 centers in Korea and 69 in Japan). The last subject's last visit occurred on 19 Nov 2010.
Of 552 subjects screened, 458 were randomized and were valid for the efficacy analyses (intent to treat \[ITT\] population), and 456 received at least 1 dose of study drug and were valid for the safety analyses. 229 subjects were randomized to each group (sorafenib or placebo).
Participant milestones
| Measure |
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
|
Placebo
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
|
|---|---|---|
|
Overall Study
STARTED
|
229
|
229
|
|
Overall Study
Received Treatment
|
229
|
227
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
229
|
229
|
Reasons for withdrawal
| Measure |
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
|
Placebo
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
|
|---|---|---|
|
Overall Study
Adverse Event
|
93
|
13
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
|
Overall Study
Disease Progression, Recurrence/Relapse
|
109
|
185
|
|
Overall Study
Participant Did Not Take Study Drug
|
0
|
2
|
|
Overall Study
Site Closed by Sponsor
|
6
|
0
|
|
Overall Study
Protocol Driven Decision Point
|
11
|
22
|
Baseline Characteristics
Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
Baseline characteristics by cohort
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=229 Participants
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
|
Placebo
n=229 Participants
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
68.1 Years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
67.8 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Child Pugh Status
Status A
|
229 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Child Pugh Status
Status B
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 0
|
201 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 1
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Responder group to transcatheter arterial chemoembolization (TACE)
Responder Group A
|
142 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Responder group to transcatheter arterial chemoembolization (TACE)
Responder Group B
|
87 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Number of Prior transcatheter arterial chemoembolization (TACE)
1
|
147 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Number of Prior transcatheter arterial chemoembolization (TACE)
2
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.Population: Intention to treat (ITT) population.
Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=229 Participants
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
|
Placebo
n=229 Participants
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
|
|---|---|---|
|
Time to Progression (TTP)
|
164 days
Interval 116.0 to 220.0
|
112 days
Interval 106.0 to 122.0
|
SECONDARY outcome
Timeframe: From randomization of the first subject until 39 months later.Population: Median overall survival (OS) and 95% Confidence interval (CI) were not estimable in Placebo Group and Upper Limit of 95% CI was not in Sorafenib Group because of more than half (188 for Placebo,186 for Sorafenib) of the individual study populations censored. Number of death is shown in "Post-Hoc Outcome Measure".
Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: From randomization of the first subject until death due to any cause assessed up to 55 months.Population: Intention to treat (ITT) population. "Overall Survival" is shown in "Secondary Outcome Measure: Overall Survival".
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=229 Participants
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
|
Placebo
n=229 Participants
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
|
|---|---|---|
|
Number of Death Cases Due to Any Cause
up to 39 months
|
43 Participants
|
41 Participants
|
|
Number of Death Cases Due to Any Cause
up to 55 months
|
50 Participants
|
56 Participants
|
Adverse Events
Sorafenib (Nexavar, BAY43-9006)
Serious events: 44 serious events
Other events: 229 other events
Deaths: 0 deaths
Placebo
Serious events: 21 serious events
Other events: 193 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=229 participants at risk
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
|
Placebo
n=227 participants at risk
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPHILS
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Blood and lymphatic system disorders
PLATELETS
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Blood and lymphatic system disorders
INR
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Cardiac disorders
CONDUCTION ABNORMALITY, AV BLOCK-3RD DEGREE (COMPLETE AV BLOCK)
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Cardiac disorders
CARDIAC ISCHEMIA/INFARCTION
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Endocrine disorders
DIABETES
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
ANOREXIA
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
ASCITES
|
1.7%
4/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
DEHYDRATION
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
DIARRHEA
|
1.3%
3/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
NAUSEA
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
GI - OTHER (SPECIFY)
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
FEVER
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
FATIGUE
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
PAIN, BACK
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
PAIN, ABDOMEN NOS
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
1.3%
3/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Hepatobiliary disorders
LIVER DYSFUNCTION
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Hepatobiliary disorders
HEPATOBILIARY - OTHER (SPECIFY)
|
1.3%
3/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY), LUNG (PNEUMONIA)
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Infections and infestations
INFECTION WITH NORMAL ANC, BLOOD
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Infections and infestations
INFECTION WITH NORMAL ANC, BILIARY TREE
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Infections and infestations
INFECTION WITH NORMAL ANC, LIVER
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Infections and infestations
INFECTION WITH NORMAL ANC, LUNG (PNEUMONIA)
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Infections and infestations
INFECTION WITH NORMAL ANC, SKIN (CELLULITIS)
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
ALT
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
AMYLASE
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
AST
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
BILIRUBIN (HYPERBILIRUBINEMIA)
|
1.3%
3/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
LIPASE
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
METABOLIC/LAB - OTHER (SPECIFY)
|
1.7%
4/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL - OTHER (SPECIFY)
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Nervous system disorders
CNS ISCHEMIA
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Nervous system disorders
ENCEPHALOPATHY
|
2.6%
6/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.88%
2/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Nervous system disorders
MOOD ALTERATION, DEPRESSION
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Renal and urinary disorders
RENAL - OTHER (SPECIFY)
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.88%
2/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Skin and subcutaneous tissue disorders
HAND-FOOT SKIN REACTION
|
1.3%
3/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY - OTHER (SPECIFY)
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
CNS HEMORRHAGE
|
1.3%
3/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
HEMORRHAGE, GI, ABDOMEN NOS
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
HEMORRHAGE, GI, COLON
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
HEMORRHAGE, GI, ESOPHAGUS
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
HEMORRHAGE, GI, VARICES (ESOPHAGEAL)
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
HEMORRHAGE, GI, STOMACH
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
HEMORRHAGE, GI, LIVER
|
0.00%
0/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
HEMORRHAGE, GI, LOWER GI NOS
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
ARTERY INJURY, AORTA
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
VASCULAR - OTHER (SPECIFY)
|
0.87%
2/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
0.44%
1/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.00%
0/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
Other adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=229 participants at risk
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
|
Placebo
n=227 participants at risk
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPHILS
|
15.3%
35/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
7.0%
16/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
7.4%
17/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
3.5%
8/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Blood and lymphatic system disorders
PLATELETS
|
27.9%
64/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
4.4%
10/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Blood and lymphatic system disorders
LEUKOCYTES
|
10.0%
23/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
6.6%
15/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
13.1%
30/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
8.8%
20/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Cardiac disorders
HYPERTENSION
|
33.2%
76/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
9.3%
21/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
ANOREXIA
|
19.7%
45/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
7.9%
18/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
ASCITES
|
11.8%
27/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
4.4%
10/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
CONSTIPATION
|
13.1%
30/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
9.3%
21/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
DIARRHEA
|
35.4%
81/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
11.9%
27/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
DISTENSION
|
5.7%
13/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
1.8%
4/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
HEARTBURN
|
6.6%
15/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
7.0%
16/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
MUCOSITIS (FUNCTIONAL/SYMPTOMATIC), ORAL CAVITY
|
11.4%
26/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
2.2%
5/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
MUCOSITIS (CLINICAL EXAM), ORAL CAVITY
|
5.7%
13/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
2.6%
6/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
NAUSEA
|
11.4%
26/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
7.9%
18/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Gastrointestinal disorders
VOMITING
|
7.0%
16/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
4.8%
11/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
FEVER
|
16.2%
37/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
11.0%
25/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
WEIGHT GAIN
|
1.7%
4/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
5.3%
12/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
FATIGUE
|
20.1%
46/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
15.0%
34/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
WEIGHT LOSS
|
12.2%
28/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
1.3%
3/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
PAIN, BACK
|
5.7%
13/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
8.4%
19/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
PAIN, EXTREMITY-LIMB
|
5.2%
12/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
4.8%
11/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
PAIN, ABDOMEN NOS
|
12.7%
29/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
9.3%
21/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
PAIN, HEAD/HEADACHE
|
10.9%
25/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
9.3%
21/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
PAIN, JOINT
|
4.4%
10/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
6.6%
15/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
General disorders
FLU-LIKE SYNDROME
|
19.2%
44/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
24.7%
56/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY)
|
5.2%
12/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
2.6%
6/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
ALKALINE PHOSPHATASE
|
7.0%
16/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
2.2%
5/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
ALT
|
25.8%
59/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
12.8%
29/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
AMYLASE
|
22.3%
51/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
7.9%
18/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
AST
|
30.6%
70/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
12.8%
29/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
BILIRUBIN (HYPERBILIRUBINEMIA)
|
15.7%
36/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
5.3%
12/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
5.2%
12/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
4.8%
11/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
8.3%
19/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
2.2%
5/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
LIPASE
|
45.9%
105/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
8.4%
19/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
34.5%
79/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
9.7%
22/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
METABOLIC/LAB - OTHER (SPECIFY)
|
37.6%
86/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
11.9%
27/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Metabolism and nutrition disorders
PROTEINURIA
|
13.5%
31/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
0.44%
1/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL - OTHER (SPECIFY)
|
8.3%
19/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
5.3%
12/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
5.7%
13/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
4.0%
9/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES
|
15.3%
35/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
1.3%
3/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
41.5%
95/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
3.5%
8/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Skin and subcutaneous tissue disorders
HAND-FOOT SKIN REACTION
|
82.1%
188/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
7.5%
17/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY - OTHER (SPECIFY)
|
5.7%
13/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
3.5%
8/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
11.4%
26/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
13.7%
31/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
43.2%
99/229
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
16.3%
37/227
Acronyms in Adverse Event section: - Absolute Neutrophil Count (ANC) - Alanine Transaminase (ALT) - Aspartate Transaminase (AST) - Atrioventricular (AV) - Central Nervous System (CNS) - Gastrointestinal (GI) - International Normalized Ratio (INR) - Not Otherwise Specified (NOS)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60