Trial Outcomes & Findings for Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor (NCT NCT00711243)
NCT ID: NCT00711243
Last Updated: 2019-02-26
Results Overview
The MTD will be determined using a 3+3 dose escalating design. There will be 5 dose cohorts: Cohort 1a 25mg/m2 Cohort 2a 30mg/m2 Cohort 3a 40 mg/m2 Cohort 4a 50 mg/m2 Cohort 5a 60 mg/m2 3 patients will be enrolled at dose of 25mg/m2 docetaxel. If no dose limiting toxicities (DLTs) are seen then dose will be escalated to next cohort and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. Dose of docetaxel will be escalated by use of cohorts until the MTD for phase II is determined. DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
59 participants
Primary outcome timeframe
After completion of 1 cycle of therapy (1 cycle = 14 days)
Results posted on
2019-02-26
Participant Flow
The study opened for accrual on March 3, 2005 and the first patient was enrolled April 20 2005. Accrual goal of approximately 50 for the phase I and phase II portion. Accrual for phase I was suspended on February 13 2006 reopened with phase II accrual on February 16, 2006. The study was closed permanently on July 23, 2008.
Phase I was opened to all solid tumor cancers and phase II was opened to stomach/gastro-esophageal junction cancer only.
Participant milestones
| Measure |
Cohort 1a
Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Phase II
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|---|
|
Registed and Started Treatment
STARTED
|
3
|
3
|
3
|
3
|
3
|
44
|
|
Registed and Started Treatment
Registered to Study
|
3
|
3
|
3
|
3
|
3
|
44
|
|
Registed and Started Treatment
Started Treatment
|
3
|
3
|
3
|
3
|
3
|
43
|
|
Registed and Started Treatment
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
43
|
|
Registed and Started Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Reached First Response/4 Cycles
STARTED
|
3
|
3
|
3
|
3
|
3
|
43
|
|
Reached First Response/4 Cycles
COMPLETED
|
3
|
3
|
3
|
2
|
3
|
41
|
|
Reached First Response/4 Cycles
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Treated Cycle 5 After First Response
STARTED
|
3
|
3
|
3
|
2
|
3
|
41
|
|
Treated Cycle 5 After First Response
COMPLETED
|
2
|
1
|
3
|
2
|
2
|
37
|
|
Treated Cycle 5 After First Response
NOT COMPLETED
|
1
|
2
|
0
|
0
|
1
|
4
|
|
Follow up Every 3 Months Until Death
STARTED
|
3
|
3
|
3
|
3
|
3
|
39
|
|
Follow up Every 3 Months Until Death
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
37
|
|
Follow up Every 3 Months Until Death
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1a
Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Phase II
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|---|
|
Registed and Started Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Reached First Response/4 Cycles
Death
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Reached First Response/4 Cycles
Progressive disease
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treated Cycle 5 After First Response
Progressive disease
|
1
|
2
|
0
|
0
|
1
|
1
|
|
Treated Cycle 5 After First Response
Death
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Treated Cycle 5 After First Response
Decline in performance status
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Follow up Every 3 Months Until Death
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor
Baseline characteristics by cohort
| Measure |
Cohort 1a
n=3 Participants
Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
n=3 Participants
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
n=3 Participants
Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
n=3 Participants
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
n=3 Participants
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Phase II
n=44 Participants
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
49 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
59 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: After completion of 1 cycle of therapy (1 cycle = 14 days)Population: Dose of docetaxel was escalated up through 5 cohorts.
The MTD will be determined using a 3+3 dose escalating design. There will be 5 dose cohorts: Cohort 1a 25mg/m2 Cohort 2a 30mg/m2 Cohort 3a 40 mg/m2 Cohort 4a 50 mg/m2 Cohort 5a 60 mg/m2 3 patients will be enrolled at dose of 25mg/m2 docetaxel. If no dose limiting toxicities (DLTs) are seen then dose will be escalated to next cohort and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. Dose of docetaxel will be escalated by use of cohorts until the MTD for phase II is determined. DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0
Outcome measures
| Measure |
Phase I
n=15 Participants
Docetaxel + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. Dose for cohorts is as follows: Cohort 1a = Docetaxel 25mg/m2 Cohort 2a = Docetaxel 30mg/m2 Cohort 3a = Docetaxel 40mg/m2 Cohort 4a = Docetaxel 50mg/m2 Cohort 5a = Docetaxel 60mg/m2
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil (Phase I)
|
50 mg/m2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: After 4 cycles of therapy (1 cycle = 14 days)Population: One patient that was registered to phase II did not get treated on study and was therefore not evaluable. Two patients did not reach first response at 4 cycles and therefore were not evaluable.
Overall Response Rate (ORR) is defined as Complete Response (CR) plus Partial Response (PR) and will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease, neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease - \<=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Phase I
n=41 Participants
Docetaxel + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. Dose for cohorts is as follows: Cohort 1a = Docetaxel 25mg/m2 Cohort 2a = Docetaxel 30mg/m2 Cohort 3a = Docetaxel 40mg/m2 Cohort 4a = Docetaxel 50mg/m2 Cohort 5a = Docetaxel 60mg/m2
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|
|
Response Rate in Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction (Phase II)
|
73.2 percentage of patients
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After 1 cycle of therapy (1 cycle = 14 days)Population: 15 patients enrolled in 5 dose escalating cohorts were monitored for DLTs in the phase I part of the study.
Dose limiting toxicities (DLT) will be graded according to National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) except for neurosensory. The occurrence of any of the following during the 1st cycle, seen in more than one patient, will constitute a DLT. Grade 3 non-hematologic toxicity(except alopecia) Grade 4 thrombocytopenia, not recovered to platelet count of \>75,000/ul by day 15. Grade 4 neutropenia, not recovered to count of \>1,500/ul by day 15. Grade 4 neutropenia with fever or infection. Grade 2 neurologic-sensory toxicity not recovered to grade 1 or better by day 15
Outcome measures
| Measure |
Phase I
n=3 Participants
Docetaxel + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. Dose for cohorts is as follows: Cohort 1a = Docetaxel 25mg/m2 Cohort 2a = Docetaxel 30mg/m2 Cohort 3a = Docetaxel 40mg/m2 Cohort 4a = Docetaxel 50mg/m2 Cohort 5a = Docetaxel 60mg/m2
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
n=3 Participants
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
n=3 Participants
Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
n=3 Participants
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
n=3 Participants
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|
|
Dose-limiting Toxicity of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil
Fatigue
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Dose-limiting Toxicity of Docetaxel When Given in Combination With Oxaliplatin and Fluorouracil
Diarrhea
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Blood sample cycle 1 day 1 and toxicity on day 1 of each cyclePopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Blood sample cycle 1 day 1 and toxicity on day 1 of each cyclePopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Blood sample cycle 1 day 1 and toxicity on day 1 of each cyclePopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 of each cycle of therapy with 1 cycle =14 days until disease progression for up to a maximum of 34 cycles and 30 days after last treatmentPopulation: Data collected and analyzed for patients enrolled in the phase II of the study only.1 Patient did not receive treatment on study and was not evaluable. For each patient that experienced the toxicity, highest grade for that patient is recorded. Grades ranging between 1-5 were collected and are represented below.
Toxicity data will be collected on day 1 of every 14 day cycle during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events (AE) version 3.0 (CTCAE v3.0). For patients that experience multiple grades of the same AE that is determined to be at least possibly related to at least one study drug, only highest grade will be collected. In general AEs will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Outcome measures
| Measure |
Phase I
n=43 Participants
Docetaxel + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. Dose for cohorts is as follows: Cohort 1a = Docetaxel 25mg/m2 Cohort 2a = Docetaxel 30mg/m2 Cohort 3a = Docetaxel 40mg/m2 Cohort 4a = Docetaxel 50mg/m2 Cohort 5a = Docetaxel 60mg/m2
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|
|
Toxicity Profile
Neutropenia
|
23 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Leukopenia
|
31 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Lymphopenia
|
15 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Anemia
|
30 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Thrombocytopenia
|
13 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Fatigue
|
36 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Vomiting
|
22 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Dehydration
|
5 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Infection
|
4 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Nausea
|
31 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Pain
|
5 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Allergy
|
4 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Transaminitis
|
7 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Rash
|
3 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Weight loss
|
6 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Anorexia
|
13 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Fever
|
4 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Hypertension
|
2 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Hyperglycemia
|
3 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Diarrhea
|
22 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Constipation
|
10 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Mucositis
|
14 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Neuro-sens
|
30 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Neuro-motor
|
2 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Nail changes
|
2 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Alopecia
|
6 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Skin
|
6 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Hemorrhage
|
5 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Altered taste
|
6 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Edema
|
2 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Abdominal distension
|
2 participants
|
—
|
—
|
—
|
—
|
|
Toxicity Profile
Shortness of breath
|
6 participants
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: From first day of treatment until death from any cause measured, assessed up to 4 yearsPopulation: Patients enrolled in phase II portion of the study were evaluable for OS. One patient in phase II was registered to the study but did not receive treatment and was not evaluable for OS. Two patients did not have death dates and were censored for the last known time to be living.
Median Overall Survival (OS)
Outcome measures
| Measure |
Phase I
n=43 Participants
Docetaxel + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle. Dose for cohorts is as follows: Cohort 1a = Docetaxel 25mg/m2 Cohort 2a = Docetaxel 30mg/m2 Cohort 3a = Docetaxel 40mg/m2 Cohort 4a = Docetaxel 50mg/m2 Cohort 5a = Docetaxel 60mg/m2
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
Docetaxel 40 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|
|
Median Overall Survival (OS)
|
10.3 Months
Interval 8.1 to 15.4
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1a
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 2a
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 3a
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 4a
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 5a
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase II
Serious events: 11 serious events
Other events: 43 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Cohort 1a
n=3 participants at risk
Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
n=3 participants at risk
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
n=3 participants at risk
Docetaxel 40 mg/m2+ oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
n=3 participants at risk
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
n=3 participants at risk
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Phase II
n=43 participants at risk
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Rectal bleeding
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Social circumstances
Death
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
4.7%
2/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Nervous system disorders
Speech impairment
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain metastasis
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusions
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Death
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
Other adverse events
| Measure |
Cohort 1a
n=3 participants at risk
Docetaxel 25 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 2a
n=3 participants at risk
Docetaxel 30 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 3a
n=3 participants at risk
Docetaxel 40 mg/m2+ oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 4a
n=3 participants at risk
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Cohort 5a
n=3 participants at risk
Docetaxel 60 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
Phase II
n=43 participants at risk
Docetaxel 50 mg/m2 + oxaliplatin 85 mg/m2 + 5-Fluorouracil 2.4 gm/m2
docetaxel: Docetaxel at the dose indicated by the patient cohort, administered intravenously in 5% dextrose over 1 hour on day 1 of each cycle.
fluorouracil: Intravenous infusion at 85 mg/m2 continuously over 46 hours beginning each cycle after docetaxel administration.
oxaliplatin: Oxaliplatin 2.4 gm/m2 administered intravenously in 5% dextrose over 2 hours each cycle beginning immediately following docetaxel
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
53.5%
23/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
72.1%
31/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Nervous system disorders
Sensory neuropathy
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
69.8%
30/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
34.9%
15/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
51.2%
22/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
32.6%
14/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
83.7%
36/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
69.8%
30/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
51.2%
22/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
11.6%
5/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Infections and infestations
Infection
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
9.3%
4/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
30.2%
13/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
72.1%
31/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Pain
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
11.6%
5/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Immune system disorders
Allergy
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
9.3%
4/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Metabolism and nutrition disorders
Transaminitis
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
16.3%
7/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
7.0%
3/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Weight loss
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
30.2%
13/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Fever
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
9.3%
4/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
3/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
7.0%
3/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
23.3%
10/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Metabolism and nutrition disorders
Albumin, serum low
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Nervous system disorders
Motor Neuropathy
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
4.7%
2/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
4.7%
2/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
14.0%
6/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Respiratory, thoracic and mediastinal disorders
Skin
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
14.0%
6/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Hemorrhage
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
11.6%
5/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
Altered taste
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
14.0%
6/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Blood and lymphatic system disorders
Edema
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
4.7%
2/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
66.7%
2/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
14.0%
6/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Metabolism and nutrition disorders
Creatinine, Serum high
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Ear and labyrinth disorders
Auditory
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Insomnia
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
GI distention
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
4.7%
2/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
General disorders
Nose bleed
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Nervous system disorders
Speech
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
4.7%
2/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
|
Gastrointestinal disorders
GI Bleed
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
33.3%
1/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
0.00%
0/3 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
2.3%
1/43 • Adverse events were collected over a 4 year period across the study.
Adverse events were collected in systematic assessment every two weeks during patient visit. For each patient the highest grade of clinically significant adverse events were collected only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place