Trial Outcomes & Findings for Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer (NCT NCT00291486)
NCT ID: NCT00291486
Last Updated: 2022-10-10
Results Overview
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0). DLT was defined as any of the following related events: Any grade 2 or greater allergic reaction related to huA33. Any grade ≥ 3 non-haematological toxicity related to 131I-huA33 or capecitabine. * These toxicities included palmar plantar erythema, but skin rash thought to be related to huA33 protein was not a DLT as previous studies have shown no relation of this toxicity to dose of huA33 or radioiodine dose. * Capecitabine cardiotoxicity grade ≥ 3 - including vasospasm, acute coronary syndrome and arrhythmia, necessitated the cessation of study drug in the affected patient but were not considered DLT as these are recognized as idiosyncratic in nature and not known to be related to capecitabine dose. Any grade ≥ 4 neutropenia ≥ 7 days in duration or any thrombocytopenia with a platelet count \< 10 x 10\^9/L.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
7 weeks
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
Cohort 1
20 millicurie (mCi) 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 millicurie (mCi) 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 millicurie (mCi) 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 millicurie (mCi) 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 millicurie (mCi) 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
3
|
3
|
4
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
20 millicurie (mCi) 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 millicurie (mCi) 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 millicurie (mCi) 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 millicurie (mCi) 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 millicurie (mCi) 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease progression
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
n=6 Participants
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150mg.
|
Cohort 3
n=3 Participants
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
n=3 Participants
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
n=4 Participants
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Total
n=19 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=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
13 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
2 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
17 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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=8 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
19 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: All patients who received at least one dose of study treatment.
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0). DLT was defined as any of the following related events: Any grade 2 or greater allergic reaction related to huA33. Any grade ≥ 3 non-haematological toxicity related to 131I-huA33 or capecitabine. * These toxicities included palmar plantar erythema, but skin rash thought to be related to huA33 protein was not a DLT as previous studies have shown no relation of this toxicity to dose of huA33 or radioiodine dose. * Capecitabine cardiotoxicity grade ≥ 3 - including vasospasm, acute coronary syndrome and arrhythmia, necessitated the cessation of study drug in the affected patient but were not considered DLT as these are recognized as idiosyncratic in nature and not known to be related to capecitabine dose. Any grade ≥ 4 neutropenia ≥ 7 days in duration or any thrombocytopenia with a platelet count \< 10 x 10\^9/L.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
n=6 Participants
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
n=3 Participants
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
n=3 Participants
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
n=4 Participants
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Number of Patients With Dose-Limiting Toxicities (DLT)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: All patients who received at least one dose of study treatment and were evaluable for response. One patient in Cohort 5 was not evaluable due to the patient's request to discontinue the study prior to this evaluation.
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST at Screening (within 2 weeks of the first dose of study treatment), and at week 13. Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria (Therasse et al 2000).
Outcome measures
| Measure |
Cohort 1
n=3 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
n=6 Participants
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
n=3 Participants
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
n=3 Participants
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
n=3 Participants
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Number of Patients With Tumour Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST).
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Tumour Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST).
PR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Tumour Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST).
SD
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Tumour Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST).
PD
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: All patients who received the initial infusion of 131I-huA33.
T1/2 biological is the clearance of the isotope from the whole body. Following the initial 131I-huA33 infusion, gamma camera scans were acquired over a 1 week period (1-4 hours, Day 1, Day 2 or 3, and Day 4 or 5). Whole body clearance, or biological half time, T1/2 biological, was calculated from the whole body anterior and posterior planar images. A region of interest (ROI) was calculated to encompass the whole body, and for each ROI at each time point, the mean counts per pixel per minute was normalised to imaging time point Day 1.
Outcome measures
| Measure |
Cohort 1
n=19 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Biodistribution of 131I-huA33 Measured by Whole Body Clearance and Normal Organ Clearance Reported as Mean Biological Half-life (T1/2 Biological) After Initial 131I-huA33 Infusion
Whole Body Clearance (T1/2 biologic)
|
219.56 hours
Standard Deviation 62.81
|
—
|
—
|
—
|
—
|
|
Biodistribution of 131I-huA33 Measured by Whole Body Clearance and Normal Organ Clearance Reported as Mean Biological Half-life (T1/2 Biological) After Initial 131I-huA33 Infusion
Normal Organ Clearance in the Liver (T1/2 biological - liver)
|
62.29 hours
Standard Deviation 22.05
|
—
|
—
|
—
|
—
|
|
Biodistribution of 131I-huA33 Measured by Whole Body Clearance and Normal Organ Clearance Reported as Mean Biological Half-life (T1/2 Biological) After Initial 131I-huA33 Infusion
Normal Organ Clearance in the kidney (T1/2 biological - kidney)
|
104.89 hours
Standard Deviation 56.22
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 weekPopulation: All patients who received the initial infusion of 131I-huA33.
Gamma camera imaging with anterior and posterior whole body scans using conjugate view methodology were performed on four occasions (1-4 hours, Day 1, Day 2 or 3, and Day 4 or 5) following completion of the intravenous initial infusion. Dosimetric analysis was performed on the series of gamma camera whole-body planar images acquired in all patients following the first infusion. Organ radioactivity content was estimated from the geometric mean of anterior and posterior regions of interest counts. The counts for each organ were corrected for background using regions of interest drawn adjacent to each organ where whole body thickness was comparable.
Outcome measures
| Measure |
Cohort 1
n=19 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Mean Specific Absorbed Dose of 131I-huA33 for Normal Organs Calculated From the Initial Infusion
Liver
|
0.12 cGy/MBq
Standard Deviation 0.03
|
—
|
—
|
—
|
—
|
|
Mean Specific Absorbed Dose of 131I-huA33 for Normal Organs Calculated From the Initial Infusion
Spleen
|
0.18 cGy/MBq
Standard Deviation 0.06
|
—
|
—
|
—
|
—
|
|
Mean Specific Absorbed Dose of 131I-huA33 for Normal Organs Calculated From the Initial Infusion
Kidney
|
0.14 cGy/MBq
Standard Deviation 0.05
|
—
|
—
|
—
|
—
|
|
Mean Specific Absorbed Dose of 131I-huA33 for Normal Organs Calculated From the Initial Infusion
Lung
|
0.09 cGy/MBq
Standard Deviation 0.03
|
—
|
—
|
—
|
—
|
|
Mean Specific Absorbed Dose of 131I-huA33 for Normal Organs Calculated From the Initial Infusion
Red Marrow
|
0.056 cGy/MBq
Standard Deviation 0.011
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: All patients who received the initial and therapy infusions and had tumors of sufficient size for accurate tumor quantitation and dosimetry. Nine patients had tumors too small to be analyzed. Results are presented by the radiolabeled dose of huA33 given as well as all patients.
Gamma camera imaging were performed on four occasions (1-4 hours, Day 1, Day 2 or 3, and Day 4 or 5) following completion of the initial infusion and 7+2 days post-therapy infusion in week 2, and again in week 3 or 4 and week 5 following the therapy infusion. Dosimetry analysis was performed on the series of gamma camera whole-body planar images. Tumor radioactivity content after the initial infusion was estimated from the geometric mean of anterior and posterior regions of interest counts. The counts for each organ were corrected for background using regions of interest drawn adjacent to each tumor. Resultant counts were converted to activity using a camera sensitivity factor calculated from a gamma camera standard of known activity which was scanned at the same time.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
n=6 Participants
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
n=4 Participants
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Mean Total Tumor Dose of 131I-huA33
|
13.83 Gy
Standard Deviation 7.61
|
—
|
13.15 Gy
Standard Deviation 7.26
|
14.89 Gy
Standard Deviation 9.08
|
—
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: In all cohorts, both doses of huA33 were the same. The amount of radioactivity administered does not impact the PK of the protein. The results are presented for all patients who received study therapy and had PK samples taken. Two patients were not included in the determination of mean parameter values due to curve fit instability (one after initial infusion and one after therapy infusion) and one due to a positive human anti-human antibody (HAHA) response in Week 1 (therapy infusion).
Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 131I-huA33 infusion, then weekly until 4 weeks post therapy. Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA).
Outcome measures
| Measure |
Cohort 1
n=19 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by T½α and T½β (Half Lives of the Initial and Terminal Phases of Disposition, Respectively)
T½α after initial 131I-huA33 infusion
|
15.78 hours
Standard Deviation 4.68
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by T½α and T½β (Half Lives of the Initial and Terminal Phases of Disposition, Respectively)
T½α after therapy 131I-huA33 infusion
|
28.63 hours
Standard Deviation 8.93
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by T½α and T½β (Half Lives of the Initial and Terminal Phases of Disposition, Respectively)
T½β after therapy 131I-huA33 infusion
|
152.60 hours
Standard Deviation 49.59
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by T½α and T½β (Half Lives of the Initial and Terminal Phases of Disposition, Respectively)
T½β after initial 131I-huA33 infusion
|
100.24 hours
Standard Deviation 20.92
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: In all cohorts, the doses of huA33 were the same. The amount of radioactivity administered does not impact the PK of the protein. The results are presented for all patients who received study therapy and had PK samples taken. The results excluded the following patients due to curve fit instability; 1 after the initial infusion, and 1 after the therapy infusion. Another was excluded from the results measured after the therapy infusion due to a positive human anti-human antibody (HAHA) in Week 1.
Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 13II-huA33 infusion, then weekly until 4 weeks post therapy. Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA).
Outcome measures
| Measure |
Cohort 1
n=19 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by Clearance (CL)
CL after initial 131I-huA33 infusion
|
36.72 mL/hr
Standard Deviation 8.01
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by Clearance (CL)
CL after therapy 131I-huA33 infusion
|
32.60 mL/hr
Standard Deviation 8.02
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: CL is a key parameter to assess the impact of capecitabine on huA33 therapy. The doses of huA33 were the same, results are presented by capecitabine dose level in patients who received study therapy and had PK samples taken. The results excluded the following patients due to curve fit instability; 1 after the initial infusion, and 1 after the therapy infusion. Another was excluded from the results measured after the therapy infusion due to a positive human anti-human antibody (HAHA) in Week 1.
Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 13II-huA33 infusion, then weekly until 4 weeks post therapy. Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA).
Outcome measures
| Measure |
Cohort 1
n=9 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
n=6 Participants
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
n=4 Participants
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Impact of Capecitabine on 131I-huA33 Clearance (CL) as Measured by Initial and Therapy Dose Clearance (CL)
Initial dose CL
|
34.88 ml/hr
Standard Deviation 9.81
|
40.54 ml/hr
Standard Deviation 7.41
|
34.65 ml/hr
Standard Deviation 1.85
|
—
|
—
|
|
Impact of Capecitabine on 131I-huA33 Clearance (CL) as Measured by Initial and Therapy Dose Clearance (CL)
Therapy dose CL
|
26.88 ml/hr
Standard Deviation 6.66
|
39.41 ml/hr
Standard Deviation 5.55
|
35.53 ml/hr
Standard Deviation 4.76
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: In all cohorts, both doses of huA33 were the same. The amount of radioactivity administered does not impact the PK of the protein. The results excluded the following patients due to curve fit instability; 1 after the initial infusion, and 1 after the therapy infusion. Another was excluded from the results measured after the therapy infusion due to a positive human anti-human antibody (HAHA) in Week 1.
Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 131I-huA33 infusion, then weekly until 4 weeks post therapy. Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA).
Outcome measures
| Measure |
Cohort 1
n=19 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by the Volume of the Central Compartment (V1)
V1 after initial 131I-huA33 infusion
|
3204.26 mL
Standard Deviation 605.59
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by the Volume of the Central Compartment (V1)
V1 after therapy 131I-huA33 infusion
|
3363.69 mL
Standard Deviation 649.64
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: In all cohorts, both doses of huA33 were the same. The amount of radioactivity administered does not impact the PK of the protein. The results excluded the following patients due to curve fit instability; 1 after the initial infusion, and 1 after the therapy infusion. Another was excluded from the results measured after the therapy infusion due to a positive human anti-human antibody (HAHA) in Week 1.
Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 131I-huA33 infusion, then weekly until 4 weeks post therapy. Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA).
Outcome measures
| Measure |
Cohort 1
n=19 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by Maximum Serum Concentration (Cmax)
Cmax after initial 131I-huA33 infusion
|
1.53 mcg/mL
Standard Deviation 0.24
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by Maximum Serum Concentration (Cmax)
Cmax after therapy 131I-huA33 infusion
|
5.52 mcg/mL
Standard Deviation 0.77
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: In all cohorts, both doses of huA33 were the same. The amount of radioactivity administered does not impact the PK of the protein. The results excluded the following patients due to curve fit instability; 1 after the initial infusion, and 1 after the therapy infusion. Another was excluded from the results measured after the therapy infusion due to a positive human anti-human antibody (HAHA) in Week 1.
Blood samples for pharmacokinetics (PK) were drawn in week 0 immediately pre-initial 131I-huA33 infusion; then 5 minutes, 60 minutes and 2 hours post-initial 131I-huA33 infusion, Day 1, Day 2 or Day 3, Day 4 or Day 5. In week 1, PK samples were collected immediately pre-therapy 131I-huA33 infusion, 5 minutes, 24 ± 2 hours and approximately 7 days post-therapy 131I-huA33 infusion, then weekly until 4 weeks post therapy. Pharmacokinetic calculations were performed on serum 131I-huA33 data using a curve fitting Program (WinNonLin version 5.2; Pharsight Co., Mountain View, CA).
Outcome measures
| Measure |
Cohort 1
n=19 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by Area Under the Serum Concentration Curve Extrapolated to Infinite Time (AUC)
AUC after initial 131I-huA33 infusion
|
130.43 mcg.hr/mL
Standard Deviation 36.35
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of 131I-huA33 as Measured by Area Under the Serum Concentration Curve Extrapolated to Infinite Time (AUC)
AUC after therapy 131I-huA33 infusion
|
592.46 mcg.hr/mL
Standard Deviation 161.33
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: All patients who received at least one dose of study therapy and had HAHA measured at the respective timepoint.
Serum samples for human anti-human antibody (HAHA) assessment were collected prior to each 131I-huA33 infusion, at weekly intervals during weeks 0-7, then alternate weeks until the end-of-study visit. Measurement of immune responses to huA33 in patients serum was performed using a BIAcore 2000 biosensor (Biacore AB, Uppsala, Sweden).
Outcome measures
| Measure |
Cohort 1
n=3 Participants
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
n=6 Participants
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
n=3 Participants
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
n=3 Participants
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
n=4 Participants
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 3 · Negative HAHA
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 4 · Positive HAHA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 8 · Positive HAHA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 8 · Negative HAHA
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 10-11 · Positive HAHA
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 10-11 · Negative HAHA
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 12-13 · Positive HAHA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 12-13 · Negative HAHA
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Pre-treatment · Positive HAHA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Pre-treatment · Negative HAHA
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 1 · Positive HAHA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 1 · Negative HAHA
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 2 · Positive HAHA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 2 · Negative HAHA
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 3 · Positive HAHA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 5 · Positive HAHA
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 4 · Negative HAHA
|
3 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 5 · Negative HAHA
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 6 · Positive HAHA
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Human Anti-human Antibodies (HAHA) to 131I-huA33
Week 6 · Negative HAHA
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
n=6 participants at risk
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
n=3 participants at risk
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
n=3 participants at risk
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
n=4 participants at risk
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Cardiac disorders
Angina
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
20 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 2
n=6 participants at risk
30 mCi 131I-huA33, 1500 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 3
n=3 participants at risk
30 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 4
n=3 participants at risk
40 mCi 131I-huA33, 1000 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
Cohort 5
n=4 participants at risk
40 mCi 131I-huA33, 1250 mg/m2/day capecitabine
All patients received an initial dose of 5 mg huA33 conjugated to 5-8 mCi 131I on day 0.
This was followed 7 ± 2 days later by inpatient administration of the therapy dose given as a single infusion of 131I-huA33 with a constant protein dose of 10 mg/m2 huA33. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).
Capecitabine was administered at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle for 4 cycles. Daily doses were rounded to the nearest 150 mg.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
50.0%
3/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
75.0%
3/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
3/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
4/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
100.0%
4/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
4/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
100.0%
4/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
4/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Cardiac disorders
Retrosternal chest pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Anal discomfort
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
83.3%
5/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
50.0%
2/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Lip dry
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Lip ulceration
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
83.3%
5/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
100.0%
3/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
100.0%
4/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
50.0%
2/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
General disorders
Asthenia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
General disorders
Chills
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
General disorders
Edema Peripheral
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
General disorders
Hot flush
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
General disorders
Lethargy
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
100.0%
6/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
75.0%
3/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
50.0%
3/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
50.0%
2/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
50.0%
3/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Investigations
Gamma-glutamyl transferase increased
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Investigations
Weight decreased
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
50.0%
2/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Injury, poisoning and procedural complications
Myopathy steroid
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Musculoskeletal and connective tissue disorders
Upper back pain
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
66.7%
2/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
2/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Insomnia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Neuropathy
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Anosmia
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Post herpetic neuralgia
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Nervous system disorders
Weakness in extremity
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Renal and urinary disorders
Blood urea decreased
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Reproductive system and breast disorders
Vaginal pain
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
100.0%
3/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection NOS
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Contusion
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
25.0%
1/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
33.3%
1/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
16.7%
1/6 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/3 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
0.00%
0/4 • up to 13 weeks
Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective Case Report Form (CRF). All events, which occurred after signed informed consent but before first administration of study drug were to be documented on the Pre-existing Signs and Symptom page. Thereafter, they were to be documented on the AE page. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0).
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: 12124501539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place