Trial Outcomes & Findings for Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006) (NCT NCT00941863)
NCT ID: NCT00941863
Last Updated: 2016-03-22
Results Overview
MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets \< 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
158 participants
Primary outcome timeframe
21 days
Results posted on
2016-03-22
Participant Flow
The study was conducted at 3 centers in the US: the University of Wisconsin, the University of Pennsylvania, and Vanderbilt University. Enrollment began 01 Jul 2002.
Expansion in this context is an increase in the number of patients exposed to the recommended dose for this combination. The purpose of the increase was also to test efficacy signals in Metastatic Melanoma (MM).
Participant milestones
| Measure |
Sorafenib 100 mg (50-mg Tablet)
Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
|
Sorafenib 200 mg (50-mg Tablet)
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion)
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
|---|---|---|---|---|---|
|
Until Primary Completion Date (PCD)
STARTED
|
7
|
3
|
12
|
17
|
119
|
|
Until Primary Completion Date (PCD)
Maximum Tolerated Dose
|
7
|
3
|
12
|
17
|
94
|
|
Until Primary Completion Date (PCD)
COMPLETED
|
0
|
0
|
0
|
0
|
25
|
|
Until Primary Completion Date (PCD)
NOT COMPLETED
|
7
|
3
|
12
|
17
|
94
|
|
Continued After PCD
STARTED
|
0
|
0
|
0
|
0
|
25
|
|
Continued After PCD
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
|
Continued After PCD
NOT COMPLETED
|
0
|
0
|
0
|
0
|
19
|
Reasons for withdrawal
| Measure |
Sorafenib 100 mg (50-mg Tablet)
Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
|
Sorafenib 200 mg (50-mg Tablet)
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion)
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
|---|---|---|---|---|---|
|
Until Primary Completion Date (PCD)
Adverse Event
|
1
|
2
|
2
|
1
|
5
|
|
Until Primary Completion Date (PCD)
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Until Primary Completion Date (PCD)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
8
|
|
Until Primary Completion Date (PCD)
Death
|
0
|
0
|
1
|
2
|
7
|
|
Until Primary Completion Date (PCD)
Disease progression
|
6
|
1
|
8
|
14
|
73
|
|
Continued After PCD
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Continued After PCD
Disease progression, recurrence, relapse
|
0
|
0
|
0
|
0
|
18
|
Baseline Characteristics
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
Baseline characteristics by cohort
| Measure |
Sorafenib 100 mg (50-mg Tablet)
n=7 Participants
Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
|
Sorafenib 200 mg (50-mg Tablet)
n=3 Participants
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
n=12 Participants
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
n=17 Participants
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion)
n=119 Participants
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
52.8 years
STANDARD_DEVIATION 12.6 • n=21 Participants
|
52.5 years
STANDARD_DEVIATION 12.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
67 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
91 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
white
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
16 participants
n=4 Participants
|
113 participants
n=21 Participants
|
150 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Site of primary lesion
Colon
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
5 participants
n=10 Participants
|
|
Site of primary lesion
Malignant Melanoma
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
81 participants
n=21 Participants
|
105 participants
n=10 Participants
|
|
Site of primary lesion
Non Small Cell Lung
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
11 participants
n=21 Participants
|
15 participants
n=10 Participants
|
|
Site of primary lesion
Ovarian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Site of primary lesion
Renal
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
21 participants
n=21 Participants
|
23 participants
n=10 Participants
|
|
Site of primary lesion
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
7 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: All subjects who received at least 1 dose of any study drug treatment were included in the Intent-To-Treat/safety populations. Efficacy parameters of time to death, time to progression, and response rate (confirmed partial response \[PR\] plus complete response \[CR\]) were determined for this population.
MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets \< 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.
Outcome measures
| Measure |
Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid
n=39 Participants
All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid \[twice daily\], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
|
Sorafenib 200 mg (50-mg Tablet)
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion, Treatment Until PCD)
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Sorafenib 400 mg (Expansion, Treatment Continued After PCD)
25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin
|
400 mg
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Start of treatment until death or within 14 days last study drug intakePopulation: The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population.
Participants are considered at risk for toxicity if participants had a lab measurement for the toxicity \>= National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 3 as defined by the NCI CTC version 2; SGOT: Serum Glutamic-Oxaloacetic Transaminase, SGPT: Serum Glutamic-Pyruvic Transaminase, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase.
Outcome measures
| Measure |
Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid
n=7 Participants
All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid \[twice daily\], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
|
Sorafenib 200 mg (50-mg Tablet)
n=3 Participants
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
n=12 Participants
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
n=17 Participants
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion, Treatment Until PCD)
n=119 Participants
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Sorafenib 400 mg (Expansion, Treatment Continued After PCD)
n=25 Participants
25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
|
|---|---|---|---|---|---|---|
|
Participants With Hematological and Biochemical Toxicities
Bilirubin >= NCI CTC Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Participants With Hematological and Biochemical Toxicities
SGOT (AST) >= NCI CTC Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Participants With Hematological and Biochemical Toxicities
SGPT (ALT) >= NCI CTC Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Participants With Hematological and Biochemical Toxicities
Hypophosphatemia >= NCI CTC Grade 3
|
3 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
52 Participants
|
12 Participants
|
|
Participants With Hematological and Biochemical Toxicities
Hemoglobin >= NCI CTC Grade 3
|
1 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
28 Participants
|
6 Participants
|
|
Participants With Hematological and Biochemical Toxicities
Leukocytes >= NCI CTC Grade 3
|
7 Participants
|
1 Participants
|
10 Participants
|
14 Participants
|
95 Participants
|
17 Participants
|
|
Participants With Hematological and Biochemical Toxicities
Lymphopenia >= NCI CTC Grade 3
|
5 Participants
|
1 Participants
|
5 Participants
|
11 Participants
|
99 Participants
|
4 Participants
|
|
Participants With Hematological and Biochemical Toxicities
Neutrophils/ Granulocytes >= NCI CTC Grade 3
|
4 Participants
|
2 Participants
|
6 Participants
|
10 Participants
|
87 Participants
|
14 Participants
|
|
Participants With Hematological and Biochemical Toxicities
Platelets >= NCI CTC Grade 3
|
1 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
62 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until progression or death occurs assessed every 6 weeks.Population: The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population
Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.
Outcome measures
| Measure |
Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid
n=7 Participants
All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid \[twice daily\], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
|
Sorafenib 200 mg (50-mg Tablet)
n=3 Participants
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
n=12 Participants
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
n=17 Participants
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion, Treatment Until PCD)
n=119 Participants
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Sorafenib 400 mg (Expansion, Treatment Continued After PCD)
n=25 Participants
25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
|
|---|---|---|---|---|---|---|
|
Tumor Response
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Tumor Response
Partial Response (PR)
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
28 Participants
|
12 Participants
|
|
Tumor Response
Stable Disease (SD)
|
4 Participants
|
1 Participants
|
4 Participants
|
10 Participants
|
73 Participants
|
12 Participants
|
|
Tumor Response
Progressive Disease (PD)
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Tumor Response
Not Assessable
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
12 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At day 2 in studyPopulation: subjects with valid pharmacokinetics (PK) profiles
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.
Outcome measures
| Measure |
Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid
n=25 Participants
All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid \[twice daily\], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
|
Sorafenib 200 mg (50-mg Tablet)
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion, Treatment Until PCD)
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Sorafenib 400 mg (Expansion, Treatment Continued After PCD)
25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1
|
17.5 mg*h/L
Standard Deviation 2.16
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At day 2 in studyPopulation: subjects with valid PK profiles
Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.
Outcome measures
| Measure |
Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid
n=25 Participants
All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid \[twice daily\], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
|
Sorafenib 200 mg (50-mg Tablet)
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion, Treatment Until PCD)
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Sorafenib 400 mg (Expansion, Treatment Continued After PCD)
25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
|
|---|---|---|---|---|---|---|
|
Maximum Concentration (CMAX) Start From Day 2 of Cycle 1
|
3.36 mg/L
Standard Deviation 1.79
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At day 2 in studyPopulation: subjects with valid PK profiles
Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.
Outcome measures
| Measure |
Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid
n=25 Participants
All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid \[twice daily\], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
|
Sorafenib 200 mg (50-mg Tablet)
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion, Treatment Until PCD)
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Sorafenib 400 mg (Expansion, Treatment Continued After PCD)
25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
|
|---|---|---|---|---|---|---|
|
Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1
|
24.5 hours
Interval 3.0 to 36.08
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment until 18 Sep 2008, up to 6 yearsPopulation: 25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.
The responses reported in these participants were from start of treatment until 18 Sep 2008.
Outcome measures
| Measure |
Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid
n=25 Participants
All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid \[twice daily\], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
|
Sorafenib 200 mg (50-mg Tablet)
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion, Treatment Until PCD)
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Sorafenib 400 mg (Expansion, Treatment Continued After PCD)
25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
|
|---|---|---|---|---|---|---|
|
Serious Adverse Events
Hemoglobin
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Cardiovascular/Arrhythmia-Other
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Supraventricular Arrhythmias
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Cardiac-Ischemia/Infarction
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Thrombosis/Embolism
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Constitutional Symptoms-Other
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Fatigue
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Fever
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Dermatology/Skin-Other
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Gastrointestinal-Other
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Nausea
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Vomiting
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Hematuria
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Hemoptysis
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Hemorrhage-Other
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Febrile Neutropenia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Infection Without Neutropenia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Infection/Febrile Neutropenia-Other
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Hyperglycemia
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Hypoglycemia
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Hypokalemia
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Depressed Level Of Consciousness
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Syncope
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Chest Pain (NonCardiac/NonPleuritic)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Pain-Other
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Pleural Effusion (Non-Malignant)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Pneumonitis/Pulmonary Infiltrates
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Serious Adverse Events
Renal/Genitourinary-Other
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment until 18 Sep 2008, up to 6 yearsPopulation: 25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.
Frequency Threshold for reporting Other Adverse Events: 5%. The responses reported in these participants were from start of treatment until 18 Sep 2008.
Outcome measures
| Measure |
Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid
n=25 Participants
All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid \[twice daily\], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
|
Sorafenib 200 mg (50-mg Tablet)
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion, Treatment Until PCD)
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
Sorafenib 400 mg (Expansion, Treatment Continued After PCD)
25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
|
|---|---|---|---|---|---|---|
|
Other Adverse Events
Allergic Reaction/Hyper-Sensitivity
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Allergic Rhinitis
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Allergy/ Immunology-Other
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Auditory/Hearing-Other
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hemoglobin
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Leukocytes
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Neutrophils/Granulocytes
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Platelets
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Cardiovascular/General-Other
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Edema
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hypertension
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Constitutional Symptoms-Other
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Fatigue
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Fever
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Sweating (Diaphoresis)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Weight Loss
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Alopecia
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Dermatology/Skin-Other
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Dry Skin
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Flushing
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hand-Foot Skin Reaction
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Injection Site Reaction
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Pruritus
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Rash/Desquamation
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Wound-Infectious
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Wound-Non-Infectious
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Anorexia
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Constipation
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Dehydration
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Diarrhea
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Dyspepsia/Heartburn
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Dysphagia,Esophagitis,Odynophagia
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Gastrointestinal-Other
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Nausea
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Stomatitis/Pharyngitis
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Taste Disturbance (Dysgeusia)
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Vomiting
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Epistaxis
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hemorrhage-Other
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Alkaline Phosphatase
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Bilirubin
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hypoalbuminemia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Infection With Unknown Anc
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Infection Without Neutropenia
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hyperglycemia
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hypokalemia
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hypomagnesemia
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hyponatremia
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Hypophosphatemia
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Arthritis
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Musculoskeletal-Other
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Confusion
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Dizziness/Lightheadedness
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Insomnia
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Memory Loss
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Mood Alteration-Anxiety, Agitation
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Mood Alteration-Depression
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Neurology-Other
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Neuropathy-Motor
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Neuropathy-Sensory
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Vertigo
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Ocular/Visual-Other
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Vision, Blurred Vision
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Abdominal Pain Or Cramping
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Arthralgia (Joint Pain)
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Bone Pain
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Chest Pain (NonCardiac/NonPleuritic)
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Headache
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Myalgia (Muscle Pain)
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Pain-Other
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Tumor Pain
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Cough
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Rigors, Chills
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Dyspnea (Shortness Of Breath)
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Pneumonitis/Pulmonary Infiltrates
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Other Adverse Events
Voice Changes/Stridor/Larynx
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Sorafenib 100 mg (50-mg Tablet)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Sorafenib 200 mg (50-mg Tablet)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Sorafenib 400 mg (50-mg Tablet)
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Sorafenib 400 mg (200-mg Tablet)
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Sorafenib 400 mg (Expansion)
Serious events: 76 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib 100 mg (50-mg Tablet)
n=7 participants at risk
Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
|
Sorafenib 200 mg (50-mg Tablet)
n=3 participants at risk
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
n=12 participants at risk
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
n=17 participants at risk
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion)
n=119 participants at risk
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
|---|---|---|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.0%
6/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Hemoglobin (HGB)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/A FIB/FLUTT)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Cardiovascular/arrhythmias - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Coagulation - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Thrombosis/embolism
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
17.6%
3/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
6.7%
8/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Cardiac - ischemia/infarction
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Hypotension
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Pericardial effusion/pericarditis
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Phlebitis (superficial)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Edema
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Cardiovascular/general - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - other
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.4%
10/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Wound - infectious
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Wound - non-infectious
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Fever (in absence of neutropenia)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
7/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Fatigue (Lethargy, Malaise, Asthenia)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
4.2%
5/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Constitutional symptoms - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
2/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
6.7%
8/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
6.7%
8/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.0%
6/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Diarrhea, patients without colostomy
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Gastrointestinal - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painfull swallowing)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Duodenal ulcer (radiographic or endoscopic)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Renal and urinary disorders
Renal/genitourinary - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Renal and urinary disorders
Creatinine
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Renal and urinary disorders
Ureteral obstruction
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
CNS Hemorrhage/belleding
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Hemorrhage - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Melena/GI bleeding
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Hemoptysis
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Rectal bleeding/hematochezia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombo
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Hematuria (in absence of vaginal bleeding)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Vaginal bleeding
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Hepatobiliary disorders
SGPT (ALT)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Hepatobiliary disorders
SGOT (AST)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Infections and infestations
Febrile neutropenia (fever w/ unknow origin)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
10.1%
12/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
4.2%
5/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Infections and infestations
Infection (doc clinic or microbio) w/ GR 3 or 4 Neu
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Infections and infestations
Infection/febrile neutropenia - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Amylase
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Neurology - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
7.6%
9/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Confusion
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Seizure(s)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Speech impairment (dysphasia or aphasia)
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Neuropathy - motor
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Neuropathy - sensory
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Pain - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.4%
10/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Abdominal pain or cramping
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Chest pain (non-cardiac and nonpleuritic)
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Headache
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Tumor pain (onset/exacerb. tumor pain)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
7/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - other
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
Other adverse events
| Measure |
Sorafenib 100 mg (50-mg Tablet)
n=7 participants at risk
Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
|
Sorafenib 200 mg (50-mg Tablet)
n=3 participants at risk
Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (50-mg Tablet)
n=12 participants at risk
Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
|
Sorafenib 400 mg (200-mg Tablet)
n=17 participants at risk
Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
|
Sorafenib 400 mg (Expansion)
n=119 participants at risk
Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
57.1%
4/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
66.7%
8/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
52.9%
9/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
68.9%
82/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Immune system disorders
Allergic reaction/hyper-sensitivity
|
42.9%
3/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.8%
20/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Immune system disorders
Allergic rhinitis
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
10.1%
12/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Immune system disorders
Allergy/immunology - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
9.2%
11/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Ear and labyrinth disorders
Auditory/hearing - other
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Ear and labyrinth disorders
Inner ear/hearing
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Neutrophils/granolocytes (ANC/AGC)
|
100.0%
7/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
100.0%
3/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
75.0%
9/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
82.4%
14/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
73.9%
88/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Platelets
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
100.0%
3/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
66.7%
8/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
64.7%
11/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
64.7%
77/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Hemoglobin (HGB)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
58.3%
7/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
52.9%
9/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
61.3%
73/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
2/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
30.3%
36/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Edema
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
25.0%
3/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
20.2%
24/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Hypertension
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
14.3%
17/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Thrombosis/embolism
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
7/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Phlebitis (superficial)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
4.2%
5/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Cardiac disorders
Hypotension
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
52.9%
9/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
46.2%
55/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
71.4%
5/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
50.0%
6/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
35.3%
6/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
39.5%
47/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - other
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
35.3%
6/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
30.3%
36/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
13.4%
16/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
7.6%
9/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
7/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Wound - infectious
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
6.7%
8/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
4.2%
5/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of GR 3 or 4 thrombo)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Fatigue (Lethargy, Malaise, Asthenia)
|
100.0%
7/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
50.0%
6/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
52.9%
9/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
81.5%
97/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Weight loss
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
41.2%
7/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
35/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Fever (in absence of neutropenia)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
28.6%
34/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Constitutional symptoms - other
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
23.5%
4/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
22.7%
27/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Rigors, chills
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
9.2%
11/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Sweating (diaphoresis)
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.0%
6/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
66.7%
2/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
50.0%
6/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
47.1%
8/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
65.5%
78/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Diarrhea, patients without colostomy
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
66.7%
2/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
49.6%
59/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Anorexia
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
41.2%
7/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
49.6%
59/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
50.0%
6/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
45.4%
54/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Constipation
|
71.4%
5/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
23.5%
4/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
27.7%
33/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
25.0%
3/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
24.4%
29/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Gastrointestinal - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
2/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
15.1%
18/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
17.6%
3/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
13.4%
16/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
9.2%
11/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
17.6%
3/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
7.6%
9/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
7/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
4.2%
5/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Diarrhea, patients with colostomy
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Gastrointestinal disorders
Mouth dryness
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Epistaxis
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
25.0%
3/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
2/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
21.0%
25/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Hemorrhage - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.4%
10/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Vascular disorders
Vaginal bleeding
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Hepatobiliary disorders
SGOT (AST)
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
4.2%
5/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Hepatobiliary disorders
SGPT (ALT)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Hepatobiliary disorders
Bilirubin
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Infections and infestations
Infection without neutropenia
|
42.9%
3/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
41.7%
5/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
52.9%
9/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
37.0%
44/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.8%
20/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Infections and infestations
Infection/febrile neutropenia - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
13.4%
16/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
23.5%
28/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
15.1%
18/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
17.6%
3/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
7.6%
9/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
9.2%
11/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
9.2%
11/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.0%
6/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Metabolism and nutrition disorders
Metabolic/laboratory - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Neuropathy - sensory
|
85.7%
6/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
66.7%
2/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
41.7%
5/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
52.9%
9/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
61.3%
73/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Insomnia
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
2/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
18.5%
22/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Mood alteration - depression
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
23.5%
4/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
17.6%
21/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Mood alteration - anxiety, agitation
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
2/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.8%
20/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Neuropathy - motor
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.8%
20/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Neurology - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
14/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Dizziness/lightheadedness
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
10.9%
13/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Memory loss
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
4.2%
5/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Confusion
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
1.7%
2/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Speech impairment (dysphasia or aphasia)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.84%
1/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Eye disorders
Vision, blurred vision
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
7.6%
9/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Eye disorders
Ocular/visual - other
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Myalgia (muscle pain)
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
4/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
47.1%
8/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
54.6%
65/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Pain - other
|
42.9%
3/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
4/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
52.1%
62/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Arthralgia (joint pain)
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
43.7%
52/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Abdominal pain or cramping
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
25.0%
3/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
17.6%
3/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
24.4%
29/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Headache
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
23.5%
4/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
21.0%
25/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Bone pain
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
1/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
8.3%
1/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
14.3%
17/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Chest pain (non-cardiac and non-pleuritic)
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
12.6%
15/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Tumor pain (onset/exacerb. tumor pain)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
2/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
10.1%
12/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
General disorders
Neuropathic pain (jaw, neuro, limb pain)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
28.6%
2/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
33.3%
4/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
35.3%
6/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
47.1%
56/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
4/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
25.0%
3/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
29.4%
5/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
31.1%
37/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx (hoarseness)
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
11.8%
2/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
13.4%
16/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - other
|
14.3%
1/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
7.6%
9/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
16.7%
2/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
3.4%
4/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/7 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/3 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
0.00%
0/12 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
5.9%
1/17 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
2.5%
3/119 • Time frame for expansion group is from start of treatment until April 2008, up to 6 years.
Acronyms in Adverse Event Section: White Blood Cell (WBC) Absolute Neutrophil Count (ANC) Absolute Granulocyte Count (AGC) Alanine Transaminase (ALT) Aspartate Transaminase (AST) Grade (GR) Gastrointestinal (GI) Central Nervous System (CNS) Fibrillation/Flutter (FIB/FLUTT) Neutropenia (Neu) documented (doc)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor recognizes right of principle investigator (PI) to publish results on completion of study, however, PI must provide draft of the communication to sponsor for approval 30 days prior to submission for publication. In case of difference of opinion between sponsor and PI, the parties will seek a solution satisfactory to both.
- Publication restrictions are in place
Restriction type: OTHER