Trial Outcomes & Findings for AMG 102 and Avastin for Recurrent Malignant Glioma (NCT NCT01113398)
NCT ID: NCT01113398
Last Updated: 2015-12-10
Results Overview
The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is 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 and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
2 years
Results posted on
2015-12-10
Participant Flow
Participant milestones
| Measure |
AMG 102 With Avastin
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
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|---|---|
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Overall Study
STARTED
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36
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Overall Study
COMPLETED
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36
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AMG 102 and Avastin for Recurrent Malignant Glioma
Baseline characteristics by cohort
| Measure |
AMG 102 With Avastin
n=36 Participants
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
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|---|---|
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Age, Continuous
|
53.6 years
STANDARD_DEVIATION 11.1 • n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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22 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 2 yearsPopulation: Intent-to-treat
The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is 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 and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.
Outcome measures
| Measure |
AMG 102 With Avastin
n=36 Participants
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
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|---|---|
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Radiographic Response
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27.8 percentage of participants
Interval 15.7 to 44.1
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SECONDARY outcome
Timeframe: 2 yearsPopulation: Intent-to-treat
Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Outcome measures
| Measure |
AMG 102 With Avastin
n=36 Participants
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
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|---|---|
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Median Overall Survival (OS)
|
11.2 Months
Interval 7.0 to 17.5
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat
The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.
Outcome measures
| Measure |
AMG 102 With Avastin
n=36 Participants
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
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|---|---|
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Six-month Progression-free Survival (PFS6)
|
41.7 percentage of participants
Interval 25.6 to 57.0
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SECONDARY outcome
Timeframe: 2 yearsPopulation: Intent-to-treat
The percentage of participants who experience unacceptable toxicity, defined as any treatment-related grade 2 or greater CNS hemorrhage or grade 4 or greater non-hematologic toxicity, will be calculated.
Outcome measures
| Measure |
AMG 102 With Avastin
n=36 Participants
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
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|---|---|
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Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities
|
5.5 percentage of participants
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Adverse Events
AMG 102 With Avastin
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMG 102 With Avastin
n=36 participants at risk
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
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|---|---|
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General disorders
Death NOS
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
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Injury, poisoning and procedural complications
Fracture
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
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|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
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|
Nervous system disorders
Seizure
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Vascular disorders
Thromboembolic event
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
Other adverse events
| Measure |
AMG 102 With Avastin
n=36 participants at risk
Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.
AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
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|---|---|
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Cardiac disorders
Ventricular arrhythmia
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Eye disorders
Blurred vision
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Eye disorders
Extraocular muscle paresis
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
6/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Cardiac disorders
Palpitations
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Eye disorders
Eye disorders - Other, specify
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Eye disorders
Photophobia
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
13.9%
5/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Anal mucositis
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Anal pain
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Constipation
|
19.4%
7/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
9/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Gingival pain
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Lip pain
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
9/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Periodontal disease
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Toothache
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Chills
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Edema face
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Edema limbs
|
30.6%
11/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Edema trunk
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Fatigue
|
72.2%
26/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Fever
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Gait disturbance
|
13.9%
5/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Injection site reaction
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Pain
|
22.2%
8/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Bronchial infection
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Gum infection
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
13.9%
5/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Lung infection
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Mucosal infection
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Sinusitis
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Skin infection
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Infections and infestations
Wound infection
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Injury, poisoning and procedural complications
Burn
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
9/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Alkaline phosphatase increased
|
27.8%
10/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
6/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Blood bilirubin increased
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Creatinine increased
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Neutrophil count decreased
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Platelet count decreased
|
36.1%
13/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Weight gain
|
36.1%
13/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Weight loss
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
White blood cell decreased
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.4%
16/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
18/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
52.8%
19/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
8/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
8/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
13.9%
5/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.9%
5/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Ataxia
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Cognitive disturbance
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Dizziness
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Dysgeusia
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Dysphasia
|
25.0%
9/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Headache
|
36.1%
13/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Memory impairment
|
16.7%
6/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.9%
5/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Seizure
|
33.3%
12/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Tremor
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Agitation
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Anxiety
|
13.9%
5/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Confusion
|
19.4%
7/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Depression
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Insomnia
|
27.8%
10/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Renal and urinary disorders
Urinary frequency
|
13.9%
5/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Renal and urinary disorders
Urinary incontinence
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
38.9%
14/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
10/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
8/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
4/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
38.9%
14/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
3/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
6/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
19.4%
7/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Vascular disorders
Flushing
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Vascular disorders
Hypertension
|
22.2%
8/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Vascular disorders
Thromboembolic event
|
2.8%
1/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
5.6%
2/36 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and AEs requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. The AEs for this study were collected using CTCAE v.3.0, and have been converted to CTCAE v. 4.0 for entry into ClinicalTrials.gov.
|
Additional Information
Katherine B. Peters, MD, PhD
Duke University Medical Center
Phone: 919-684-6173
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place