Trial Outcomes & Findings for Ph II Bevacizumab + Etoposide for Pts w Recurrent MG (NCT NCT00612430)
NCT ID: NCT00612430
Last Updated: 2013-08-12
Results Overview
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
6 months
Results posted on
2013-08-12
Participant Flow
Participant milestones
| Measure |
Grade III
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
Grade IV
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
27
|
|
Overall Study
COMPLETED
|
32
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ph II Bevacizumab + Etoposide for Pts w Recurrent MG
Baseline characteristics by cohort
| Measure |
Grade III
n=32 Participants
|
Grade IV
n=27 Participants
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
45.9 years
FULL_RANGE 24.5-61.7 • n=5 Participants
|
54.3 years
FULL_RANGE 24.1-70.4 • n=7 Participants
|
48.5 years
FULL_RANGE 24.1-70.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans.
Outcome measures
| Measure |
Grade III
n=32 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
Grade IV
n=27 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
|---|---|---|
|
6 Month Progression-Free Survival (PFS)
|
41 percentage of participants
Interval 24.0 to 57.0
|
44 percentage of participants
Interval 26.0 to 62.0
|
SECONDARY outcome
Timeframe: 2 yearsThe percentage of participants with complete or partial response as determined by the following criteria: complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination; partial response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. A confirmation of response was not required.
Outcome measures
| Measure |
Grade III
n=32 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
Grade IV
n=27 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
|---|---|---|
|
Objective Response Rate
|
24 percentage of participants
|
23 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants experiencing a non-hematologic toxicity ≥ grade 3 that was possibly, probably, or definitely related to study treatment.
Outcome measures
| Measure |
Grade III
n=32 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
Grade IV
n=27 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
|---|---|---|
|
Safety of Study Treatment Regimen
|
9 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Patients were followed for a median of 91.4 weeksTime in weeks from the start of study treatment to the date of first progression, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
Grade III
n=32 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
Grade IV
n=27 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
|---|---|---|
|
Median Progression-Free Survival
|
24 weeks
Interval 16.0 to 33.0
|
18 weeks
Interval 13.0 to 40.0
|
SECONDARY outcome
Timeframe: median of 91.4 weeksTime in weeks from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
Grade III
n=32 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
Grade IV
n=27 Participants
Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
|
|---|---|---|
|
Median Overall Survival (OS)
|
63.1 weeks
Interval 36.0 to
Follow-up was not long enough to provide an upper confidence limit for the median survival.
|
46.4 weeks
Interval 25.0 to 70.0
|
Adverse Events
Grade III
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Grade IV
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Grade III
n=32 participants at risk
|
Grade IV
n=27 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Colonic ulcer
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Stomach pain
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Death NOS
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Enterocolitis infectious
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Lung infection
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Lipase increased
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Seizure
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Other adverse events
| Measure |
Grade III
n=32 participants at risk
|
Grade IV
n=27 participants at risk
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.1%
9/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
63.0%
17/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
14.8%
4/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
25.9%
7/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
22.2%
6/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
22.2%
6/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
29.6%
8/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
40.6%
13/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
33.3%
9/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Intracranial hemorrhage
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Memory impairment
|
18.8%
6/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
48.1%
13/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.8%
6/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
18.5%
5/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Ataxia
|
25.0%
8/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
48.1%
13/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Cognitive disturbance
|
37.5%
12/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
44.4%
12/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Depressed level of consciousness
|
34.4%
11/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
33.3%
9/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
14.8%
4/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysgeusia
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysphasia
|
21.9%
7/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
33.3%
9/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Facial nerve disorder
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Mood alteration, NOS
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Fell; hematoma on scalp
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Peripheral neuropathy
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Oculomotor nerve disorder
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Platelet count decreased
|
18.8%
6/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
51.9%
14/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight gain
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight loss
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
White blood cell decreased
|
53.1%
17/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
81.5%
22/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
6/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
25.9%
7/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Blood and lymphatic system disorders
Anemia
|
31.2%
10/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
70.4%
19/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Cardiac disorders
Cardiac disorders - Other, specify: S1-S2 with grade II/IV murmur
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Variable Heart Rate
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Cardiac disorders
Cardiac disorders - Other, specify: Angina
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Blurred vision
|
15.6%
5/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Eye disorders - Other, specify: Partial right homonymous hemianopsia
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Eye disorders - Other, specify: Visual acuity
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Eye disorders - Other, specify: Proptosis/enophthalmos
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Eye pain
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Flashing lights
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Night blindness
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Photophobia
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Retinopathy
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Constipation
|
18.8%
6/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
33.3%
9/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
21.9%
7/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
22.2%
6/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dysphagia
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastric ulcer
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
37.5%
12/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
40.7%
11/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Nausea
|
34.4%
11/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
22.2%
6/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Oral pain
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Rectal ulcer
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Stomach pain
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
8/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema face
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema limbs
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fatigue
|
53.1%
17/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
63.0%
17/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fever
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Gait disturbance
|
12.5%
4/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Non-cardiac chest pain
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Pain
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations - Other, specify: Lung Abcess
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations - Other, specify: Bronchitis
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Lung infection
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Nail infection
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Sinusitis
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Skin infection
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Tooth infection
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Upper respiratory infection
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
6/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
29.6%
8/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
18.5%
5/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Aspartate aminotransferase increased
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Cholesterol high
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Neutrophil count decreased
|
53.1%
17/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
66.7%
18/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
18.8%
6/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
44.4%
12/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
4/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
29.6%
8/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Seizure
|
25.0%
8/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
14.8%
4/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
33.3%
9/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Agitation
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
14.8%
4/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Anxiety
|
12.5%
4/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Confusion
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
33.3%
9/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
14.8%
4/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Insomnia
|
25.0%
8/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
29.6%
8/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Proteinuria
|
34.4%
11/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary incontinence
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
14.8%
4/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary retention
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Breast pain
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify: Sexual Dysfunction, NOS
|
18.8%
6/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
25.9%
7/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.6%
5/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
4/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
29.6%
8/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
11.1%
3/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.4%
3/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.9%
7/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
7.4%
2/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Folliculitis
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Sore behind ear
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Petechiae/purpura- face all over
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
3.7%
1/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hot flashes
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hypertension
|
31.2%
10/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
25.9%
7/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
0.00%
0/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Thromboembolic event
|
6.2%
2/32 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
14.8%
4/27 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place