Trial Outcomes & Findings for Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer (NCT NCT00126594)
NCT ID: NCT00126594
Last Updated: 2016-09-16
Results Overview
ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.
Results posted on
2016-09-16
Participant Flow
Recruitment Period: June 23, 2005 to June 28, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Sorafenib Tosylate
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
39
|
37
|
Reasons for withdrawal
| Measure |
Sorafenib Tosylate
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Overall Study
Ineligible
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Adverse Event
|
7
|
5
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
Disease Progression
|
29
|
24
|
Baseline Characteristics
Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib Tosylate
n=40 Participants
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
n=40 Participants
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
n=99 Participants
|
60.7 years
n=107 Participants
|
62.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
ECOG (Performance Status)
0
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
ECOG (Performance Status)
1
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Nephrectomy
Yes
|
40 participants
n=99 Participants
|
39 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Nephrectomy
No
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Risk
Low
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Risk
Intermediate
|
19 participants
n=99 Participants
|
18 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Risk
Poor
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Number of Metastatic Sites
One
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Number of Metastatic Sites
Two
|
17 participants
n=99 Participants
|
20 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Number of Metastatic Sites
Three or More
|
10 participants
n=99 Participants
|
6 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Sites of Metastatic Disease
Lung
|
33 participants
n=99 Participants
|
30 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Sites of Metastatic Disease
Lymph Nodes
|
20 participants
n=99 Participants
|
15 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Sites of Metastatic Disease
Liver
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Sites of Metastatic Disease
Bone
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Sites of Metastatic Disease
Other
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
38 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.Population: Analysis performed for the intent-to-treat population.
ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.
Outcome measures
| Measure |
Sorafenib Tosylate
n=40 Participants
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
n=40 Participants
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
30 percentage of participants
Interval 16.56 to 46.53
|
25 percentage of participants
Interval 12.69 to 41.2
|
SECONDARY outcome
Timeframe: Up to 12 months of treatmentPopulation: All participants were included in adverse event reporting per intent to treat analysis.
Adverse events graded using the CTCAE version 4.0 tabulated by treatment arm within either toxicity grade for the treatment period. Treatment-related toxicity (acute and cumulative) performed every 8 weeks during the first year.
Outcome measures
| Measure |
Sorafenib Tosylate
n=40 Participants
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
n=40 Participants
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Fatigue
|
10 participants
|
13 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Diarrhea
|
13 participants
|
8 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hand-Foot Syndrome
|
10 participants
|
7 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hyperuricemia
|
12 participants
|
3 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hyperamylasemia or Lipasemia
|
5 participants
|
4 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Dyspnea
|
4 participants
|
4 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hypophosphatemia
|
3 participants
|
5 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Neutropenia
|
0 participants
|
6 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hypertension
|
2 participants
|
3 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Nausea and vomiting
|
1 participants
|
3 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Rash/Desquamation
|
2 participants
|
2 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Proteinuria
|
1 participants
|
2 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Syncope (Fainting)
|
0 participants
|
3 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Weight Loss
|
0 participants
|
3 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Transaminitis
|
0 participants
|
3 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hyponatremia
|
2 participants
|
1 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Nonneutropenic Infection
|
2 participants
|
0 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Sensory Neuropathy
|
1 participants
|
1 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Cardiac Ischemia/Infarction
|
1 participants
|
0 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Appendicitis
|
1 participants
|
0 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Pancreatitis
|
1 participants
|
0 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Adrenal Insufficiency
|
0 participants
|
1 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Reversible Posterior Leukonencephalopathy
|
0 participants
|
1 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Small Bowel Obstruction
|
1 participants
|
0 participants
|
|
Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Pneumonitis
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 monthsPopulation: All participants were included per intent to treat analysis.
Progression free survival (PFS) is defined as the time interval from the start of protocol therapy to death or disease progression.
Outcome measures
| Measure |
Sorafenib Tosylate
n=40 Participants
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
n=40 Participants
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Progression-free Survival
|
7.39 Months
Interval 5.52 to 9.2
|
7.56 Months
Interval 5.19 to 11.07
|
SECONDARY outcome
Timeframe: From the start of protocol therapy to death or date of last follow-up, up to 36 monthsPopulation: Participants who die of unrelated cause during therapy or are lost to follow-up were censored. Median OS was not reached in Arm 1: Sorafenib as subjects experienced different events that made further follow-up impossible i.e. disease complications, death or lost to follow-up so overall survival data was not attainable.
Overall survival defined as the time interval from the start of protocol therapy to death or date of last follow-up if alive.
Outcome measures
| Measure |
Sorafenib Tosylate
n=40 Participants
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
n=40 Participants
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Median Overall Survival (OS)
|
NA Months
Median OS nor limits attained due to censoring of participants who died of unrelated cause during therapy or were lost to follow-up.
|
27.04 Months
Interval 22.31 to
Upper limit not attained due to censoring of participants who died of unrelated cause during therapy or were lost to follow-up.
|
SECONDARY outcome
Timeframe: From the date response is confirmed to the date of disease progression, up to 12 monthsPopulation: Combined analysis reflects overall stable disease duration e.g. duration of benefit for stable disease cases without being affected by the median duration not attainable for the separate arms; 37 participants in the two arms met "Stable Disease" criteria: 17 in Sorafenib alone (Arm I) and 20 in the Sorafenib Plus Interferon group (Arm II).
Duration of response for participants with disease stabilization following treatment as measured from the date response is confirmed to the date of disease progression, first assessed up to 8 weeks (2 cycles) following start of treatment. The duration of a Stable Disease (SD) response is measured from the time measurement criteria are met for that specific SD response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Repeat radiologic studies (CT, MRI, Chest x-ray and bone scan as indicated) to evaluate disease progression or response every 8 weeks.
Outcome measures
| Measure |
Sorafenib Tosylate
n=37 Participants
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Duration of Response for Participants With Stable Disease (N=37) Following Treatment
|
5.7 Months
Interval 3.7 to 8.4
|
—
|
POST_HOC outcome
Timeframe: From the date response is confirmed to the date of disease progression, first assessed 2 months (8 weeks) following start of treatment and reassessed up to 36 months (on average reassessed 12 months or less).Population: All participants were included per intent to treat analysis.
Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response assignment will depend on the achievement of both measurement and confirmation criteria as defined by RECIST: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.
Outcome measures
| Measure |
Sorafenib Tosylate
n=40 Participants
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
n=40 Participants
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Best Overall Response for Participants
Complete Response (CR)
|
1 participants
|
0 participants
|
|
Best Overall Response for Participants
Partial Response (PR)
|
11 participants
|
10 participants
|
|
Best Overall Response for Participants
Stable Disease (SD)
|
17 participants
|
20 participants
|
|
Best Overall Response for Participants
Progressive Disease (PD)
|
6 participants
|
7 participants
|
|
Best Overall Response for Participants
Inevaluable
|
5 participants
|
3 participants
|
Adverse Events
Sorafenib Tosylate
Serious events: 29 serious events
Other events: 40 other events
Deaths: 0 deaths
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Serious events: 30 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib Tosylate
n=40 participants at risk
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
n=40 participants at risk
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
General disorders
Death
|
67.5%
27/40 • Number of events 27 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
72.5%
29/40 • Number of events 29 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Hepatobiliary disorders
Pancreatitis
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Infections and infestations
Appendicitis
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
15.0%
6/40 • Number of events 12 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Serum amylase increased
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Lipase Increased
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
Other adverse events
| Measure |
Sorafenib Tosylate
n=40 participants at risk
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
|
Sorafenib Tosylate, Recombinant Interferon Alfa-2b
n=40 participants at risk
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
4/40 • Number of events 4 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
10.0%
4/40 • Number of events 5 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.5%
7/40 • Number of events 15 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
25.0%
10/40 • Number of events 12 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
17.5%
7/40 • Number of events 10 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
57.5%
23/40 • Number of events 41 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
32.5%
13/40 • Number of events 19 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
27.5%
11/40 • Number of events 14 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Immune system disorders
Allergic rhinitis
|
5.0%
2/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 5 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
55.0%
22/40 • Number of events 22 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
50.0%
20/40 • Number of events 20 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Blood and lymphatic system disorders
Anemia
|
47.5%
19/40 • Number of events 30 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
75.0%
30/40 • Number of events 60 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Anorexia
|
22.5%
9/40 • Number of events 10 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
25.0%
10/40 • Number of events 17 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Infections and infestations
Appendicitis
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
8/40 • Number of events 21 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
17.5%
7/40 • Number of events 23 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
2/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
55.0%
22/40 • Number of events 33 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
72.5%
29/40 • Number of events 55 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.5%
11/40 • Number of events 20 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
32.5%
13/40 • Number of events 42 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Renal and urinary disorders
Bladder infection
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Renal and urinary disorders
Bladder spasm
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
22.5%
9/40 • Number of events 17 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
27.5%
11/40 • Number of events 17 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Eye disorders
Blurred vision
|
7.5%
3/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
12.5%
5/40 • Number of events 9 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.0%
6/40 • Number of events 16 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
15.0%
6/40 • Number of events 20 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Chills
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Cholesterol high
|
37.5%
15/40 • Number of events 25 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
17.5%
7/40 • Number of events 12 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Cardiac disorders
Conduction disorder
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
4/40 • Number of events 9 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
12.5%
5/40 • Number of events 11 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.5%
7/40 • Number of events 18 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
27.5%
11/40 • Number of events 19 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
25.0%
10/40 • Number of events 18 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
20.0%
8/40 • Number of events 15 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Psychiatric disorders
Depression
|
7.5%
3/40 • Number of events 4 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
17.5%
7/40 • Number of events 7 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Diarrhea
|
82.5%
33/40 • Number of events 375 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
80.0%
32/40 • Number of events 382 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
67.5%
27/40 • Number of events 50 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
55.0%
22/40 • Number of events 50 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Dysgeusia
|
10.0%
4/40 • Number of events 5 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
17.5%
7/40 • Number of events 7 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
3/40 • Number of events 4 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
16/40 • Number of events 33 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
50.0%
20/40 • Number of events 64 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Edema limbs
|
10.0%
4/40 • Number of events 4 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Edema trunk
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
1/40 • Number of events 8 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.5%
3/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Eye disorders
Extraocular muscle paresis
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Eye disorders
Eye disorders
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 4 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Eye disorders
Eye pain
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Fatigue
|
82.5%
33/40 • Number of events 184 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
90.0%
36/40 • Number of events 247 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Investigations
Fever
|
17.5%
7/40 • Number of events 17 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
25.0%
10/40 • Number of events 20 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Flatulence
|
17.5%
7/40 • Number of events 13 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
17.5%
7/40 • Number of events 14 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Investigations
Flu like symptoms
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 6 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Gait disturbance
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Eye disorders
Glaucoma
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • Number of events 8 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
12.5%
5/40 • Number of events 6 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 14 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
55.0%
22/40 • Number of events 42 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
42.5%
17/40 • Number of events 47 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
4/40 • Number of events 6 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
10/40 • Number of events 16 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
20.0%
8/40 • Number of events 12 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Cardiac disorders
Hypertension
|
40.0%
16/40 • Number of events 26 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
25.0%
10/40 • Number of events 14 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
50.0%
20/40 • Number of events 20 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
52.5%
21/40 • Number of events 49 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
60.0%
24/40 • Number of events 66 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
47.5%
19/40 • Number of events 37 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
4/40 • Number of events 5 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
15.0%
6/40 • Number of events 9 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
35.0%
14/40 • Number of events 37 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
55.0%
22/40 • Number of events 42 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 8 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
10/40 • Number of events 16 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
15.0%
6/40 • Number of events 9 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.5%
17/40 • Number of events 37 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
52.5%
21/40 • Number of events 42 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
5/40 • Number of events 8 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
10.0%
4/40 • Number of events 7 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
20/40 • Number of events 36 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
50.0%
20/40 • Number of events 49 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Cardiac disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Infections and infestations
Infections and infestations - (Other)
|
12.5%
5/40 • Number of events 6 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
12.5%
5/40 • Number of events 8 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Insomnia
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Lipase increased
|
12.5%
5/40 • Number of events 9 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
12.5%
5/40 • Number of events 5 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
10.0%
4/40 • Number of events 9 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
30.0%
12/40 • Number of events 51 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Mucositis oral
|
35.0%
14/40 • Number of events 77 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
45.0%
18/40 • Number of events 39 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
10/40 • Number of events 20 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
20.0%
8/40 • Number of events 15 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Nausea
|
45.0%
18/40 • Number of events 57 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
60.0%
24/40 • Number of events 60 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
2/40 • Number of events 6 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Nervous system disorders
Nervous system disorders - (Other)
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Neutrophil count decreased
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
45.0%
18/40 • Number of events 47 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Non-cardiac chest pain
|
7.5%
3/40 • Number of events 7 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 4 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Oral pain
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Ear and labyrinth disorders
Otitis media
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Pain
|
17.5%
7/40 • Number of events 17 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
12.5%
5/40 • Number of events 13 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.0%
12/40 • Number of events 35 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
35.0%
14/40 • Number of events 39 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
80.0%
32/40 • Number of events 77 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
77.5%
31/40 • Number of events 109 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Pelvic pain
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
10/40 • Number of events 20 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
35.0%
14/40 • Number of events 42 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
52.5%
21/40 • Number of events 39 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Infections and infestations
Pneumonitis
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Renal and urinary disorders
Proteinuria
|
40.0%
16/40 • Number of events 31 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
60.0%
24/40 • Number of events 48 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
8/40 • Number of events 8 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
10.0%
4/40 • Number of events 6 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
75.0%
30/40 • Number of events 63 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
65.0%
26/40 • Number of events 62 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Renal and urinary disorders
Renal and urinary disorders - (Other)
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - (Other)
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - (Other)
|
5.0%
2/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Reproductive system and breast disorders
Scrotal pain
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
Serum amylase increased
|
7.5%
3/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
10.0%
4/40 • Number of events 4 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - (Other)
|
27.5%
11/40 • Number of events 18 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
30.0%
12/40 • Number of events 25 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Sore throat
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Stomach pain
|
2.5%
1/40 • Number of events 5 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Toothache
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
2.5%
1/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Cardiac disorders
Vascular disorders - (Other)
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
5.0%
2/40 • Number of events 5 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.5%
1/40 • Number of events 1 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
7.5%
3/40 • Number of events 3 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
11/40 • Number of events 42 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
35.0%
14/40 • Number of events 34 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Eye disorders
Watering eyes
|
5.0%
2/40 • Number of events 2 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
0.00%
0/40 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
General disorders
Weight loss
|
37.5%
15/40 • Number of events 27 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
52.5%
21/40 • Number of events 42 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
|
Metabolism and nutrition disorders
White blood cell decreased
|
7.5%
3/40 • Number of events 4 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
67.5%
27/40 • Number of events 63 • Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
|
Additional Information
Eric Jonasch, MD/Associate Professor, Genitourinary Medical Oncology
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60