Trial Outcomes & Findings for Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer (NCT NCT02777385)
NCT ID: NCT02777385
Last Updated: 2024-08-01
Results Overview
Probability of participants (expressed as a percentage) without disease progression at less than or equal to12 after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2024-08-01
Participant Flow
Participant milestones
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
COMPLETED
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.79 years
STANDARD_DEVIATION 7.55 • n=93 Participants
|
63.64 years
STANDARD_DEVIATION 6.85 • n=4 Participants
|
63.7184 years
STANDARD_DEVIATION 7.17250 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
ECOG
ECOG = 0
|
36 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
ECOG
ECOG = 1
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
ECOG
ECOG = 2
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Stage
Stage = 3
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Stage
Stage = 4
|
34 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Stage
Not Stage 3 or 4
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
T Stage
T Stage = 1
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
T Stage
T Stage = 2
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
T Stage
T Stage = 3
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
T Stage
T Stage = 4
|
16 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
T Stage
T Stage = Not Available
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
N Stage
N Stage = 0
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
N Stage
N Stage = 1
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
N Stage
N Stage = 2
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
N Stage
N Stage = 3
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
N Stage
N Stage = Not Available
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Histology
Not applicable
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Histology
SQUAMOUS CELL CA KERATINIZING, NOS
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Histology
SQUAMOUS CELL CA METASTATIC, NOS
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Histology
SQUAMOUS CELL CARCINOMA, NOS
|
37 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Primary Site
Hypopharynx
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Primary Site
Larynx
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Primary Site
Oropharynx
|
27 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
p16 for oropharynx
Negative for p16 for oropharynx
|
16 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
p16 for oropharynx
Positive for p16 for oropharynx
|
22 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
p16 for oropharynx
Not Available
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All patients that received treatment and were radiologically evaluable for response.
Probability of participants (expressed as a percentage) without disease progression at less than or equal to12 after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Progression-free Survival at ≤12 Months
|
71 percentage of patients
|
83 percentage of patients
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: All patients that received treatment and were radiologically evaluable for response.
Probability of participants (expressed as a percentage) without disease progression at less than or equal to 36 months after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Progression-free Survival at ≤ 36 Months
|
57 percentage of patients
|
75 percentage of patients
|
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: All patients that received treatment and were radiologically evaluable for response.
Probability of participants (expressed as a percentage) without disease progression time from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1: Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Progression-free Survival at ≤ 48 Months
|
49 percentage of patients
|
67 percentage of patients
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All treated patients.
The number of patients who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Acute Toxicity / DLT Rate
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: All treated patients.
Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 1 year. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site.
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
1-year Locoregional Failure Rate
|
15 percent probability of participants
|
4 percent probability of participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All treated patients.
Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 3 years. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site.
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
3-year Locoregional Failure Rate
|
26 percent probability of participants
|
4 percent probability of participants
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: All patients that received treatment and were radiologically evaluable for response.
Median number of months from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1 Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
37.00 months
Interval 16.0 to
Not reached due to insufficient number of participants with event of progression
|
NA months
Interval 46.0 to
Median not reached due to insufficient number of participants with event of progression
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: All patients on study.
The length of time from start of study treatment that patients are still alive.
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Median not reached due to insufficient number of participants with event of death
|
NA months
Interval 53.0 to
Median not reached due to insufficient number of participants with event of death
|
SECONDARY outcome
Timeframe: Up to12 monthsPopulation: All patients on study.
Probability of patients (expressed as a percentage) still alive at less than or equal to 12 months after start of study.
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Overall Survival (OS) at ≤ 12 Months
|
82 percentage of patients
|
95 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All patients on study.
Probability of patients (expressed as a percentage) still alive at less than or equal to 36 months after start of study.
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Overall Survival (OS) at ≤ 36 Months
|
71 percentage of patients
|
88 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: All patients on study.
Probability of patients (expressed as a percentage) still alive at less than or equal to 48 months after start of study.
Outcome measures
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 Participants
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 Participants
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Overall Survival (OS) at ≤ 48 Months
|
71 percentage of patients
|
83 percentage of patients
|
Adverse Events
Cisplatin + Radiation + Pembrolizumab - Concurrent
Serious events: 21 serious events
Other events: 38 other events
Deaths: 11 deaths
Cisplatin + Radiation + Pembrolizumab - Sequential
Serious events: 10 serious events
Other events: 38 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 participants at risk
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 participants at risk
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.8%
4/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specifythrombocytopenia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac arrest
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifyHypertension
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Endocrine disorders
Hyperthyroidism
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Colonic perforation
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Oral pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Fever
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyDizziness
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Infusion related reaction
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Bladder infection
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyBacteremia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyLung Infection
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifySepsis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifypenumonia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifypneumonia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Lung infection
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Sepsis
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Anorexia
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Dehydration
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specifypneumonia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specifyCellulitis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specifyGJ Tube revision
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Hypotension
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
Other adverse events
| Measure |
Cisplatin + Radiation + Pembrolizumab - Concurrent
n=41 participants at risk
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
Cisplatin + Radiation + Pembrolizumab - Sequential
n=39 participants at risk
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.
Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyHeavy feet/stiffness
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyIntermittent left thigh pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Blood and lymphatic system disorders
Anemia
|
78.0%
32/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
87.2%
34/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specifygranulomatous lymphadenitis
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specifyvenous thrombosis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifyBradycardia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifyCAD
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifyCoronary artery calcifications
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifyMild aortic insufficiency
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifyMurmur
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifySVC (left)
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifychronic obstructive pulmonary disease
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Cardiac disorders - Other, specifycoronary artery disease
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Sinus bradycardia
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
15.4%
6/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Sinus tachycardia
|
36.6%
15/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
28.2%
11/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Cardiac disorders
Ventricular tachycardia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specifyEar Pressure
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specifyHearing Loss
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specifyItching Ears
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specifyOtotoxicity
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specifyRight Otalgia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Ear pain
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
15.4%
6/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
7.7%
3/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Tinnitus
|
29.3%
12/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
17.9%
7/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Endocrine disorders
Endocrine disorders - Other, specifyDiabetes
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Endocrine disorders
Endocrine disorders - Other, specifyTSH increased
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Endocrine disorders
Hyperthyroidism
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
12.8%
5/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Endocrine disorders
Hypothyroidism
|
36.6%
15/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
28.2%
11/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Eye disorders
Dry eye
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Colonic perforation
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Constipation
|
48.8%
20/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
51.3%
20/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Diarrhea
|
26.8%
11/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
28.2%
11/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Dry mouth
|
58.5%
24/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
64.1%
25/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Dysphagia
|
48.8%
20/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
71.8%
28/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Esophageal pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
17.1%
7/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
12.8%
5/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyDry Heaves
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyFracture Tooth
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyGagging
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyGum Soreness
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyOdyNphagia
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyOral cavity erythema
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyOropharvngeal Pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyPain - swallowing
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifyodyNphagia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specifypNumatosis intestinalis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Mucositis oral
|
58.5%
24/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
61.5%
24/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Nausea
|
58.5%
24/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
76.9%
30/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Oral pain
|
22.0%
9/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
30.8%
12/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
43.9%
18/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
46.2%
18/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Toothache
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
9/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
30.8%
12/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Chills
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Edema face
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Edema limbs
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Facial pain
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Fatigue
|
53.7%
22/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
53.8%
21/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Fever
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Flu like symptoms
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyBenign prostatic hyperplasia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyErythema of throat
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyExcess phlegm
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Intermittent ear pain left side jaw/oral
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyPain in right neck/oral
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyThroat pain with swallowing
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyallergies seasonal
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyintermittent L thigh pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
intermittent ear, jaw left side pain
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyneuropathic pain
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifyodyNphagia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifythroat pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
General disorders and administration site conditions - Other, specifytumor bleeding
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Localized edema
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Neck edema
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
General disorders
Pain
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
20.5%
8/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Immune system disorders
Immune system disorders - Other, specifydecreased lymphocytes
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Immune system disorders
Immune system disorders - Other, specifyseasonal allergies
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Bladder infection
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyIncreased LDH
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyOral Thrush
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyOral thrush
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyRash-forearm itching
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyShingles
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyThrush
|
24.4%
10/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
20.5%
8/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyaspiration pneumonia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifyinfusion related reaction
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Infections and infestations - Other, specifythrush
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
15.4%
6/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Mucosal infection
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Rash pustular
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Skin infection
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
48.8%
20/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
48.7%
19/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specifyInfusion Reaction
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Injury, poisoning and procedural complications
Intraoperative neurological injury
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Alanine aminotransferase increased
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
7.7%
3/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Alkaline phosphatase increased
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Aspartate aminotransferase increased
|
14.6%
6/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
7.7%
3/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Blood bilirubin increased
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
CD4 lymphocytes decreased
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Cholesterol high
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
15.4%
6/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Creatinine increased
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Hemoglobin increased
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
INR increased
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyANC Decrease
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyAlanine AmiNtransferase decreased
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyBPH destruction
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyBUN elevation
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyBUN increased
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyBlisters
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyCreatine Clearance Increased
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyElevated BUN
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyIncreased Thyroid Peroxidase Antibodies
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyLDH Increase
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyLDH increase
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyLDH increased
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyLow testosterone
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyLyme Disease
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyRadionecrosis - Mouth
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyTSH increase
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyThrush
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyThyroid Peroxodase Ab
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyVitamin D deficiency
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyelevated TSH
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyfacial infection
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyhyperhydrosis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyhyperlipidemia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyoral thrush
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifyradionecrosis
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifysoft tissue nuerosis
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Investigations - Other, specifythyroid peroxidase antibodies
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Lymphocyte count decreased
|
75.6%
31/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
84.6%
33/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Neutrophil count decreased
|
53.7%
22/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
48.7%
19/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Platelet count decreased
|
53.7%
22/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
56.4%
22/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
Weight loss
|
80.5%
33/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
84.6%
33/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Investigations
White blood cell decreased
|
73.2%
30/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
71.8%
28/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Anorexia
|
17.1%
7/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
30.8%
12/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Dehydration
|
26.8%
11/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
25.6%
10/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
10.3%
4/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
17.9%
7/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.8%
4/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
9.8%
4/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
26.8%
11/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
17.9%
7/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
15.4%
6/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
7.7%
3/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
29.3%
12/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
23.1%
9/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
51.2%
21/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
38.5%
15/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
75.6%
31/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
74.4%
29/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specifyCachexia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specifyDiabetes Type II
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specifyHYPERLIPIDEMIA
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specifyHypercholesterolemia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specifyhypercholesterolemia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Metabolism and nutrition disorders
Obesity
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.6%
6/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
12.8%
5/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
12.8%
5/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyBilateral Upper Limb Weakness
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyCervical spondylosis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyJaw Pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyOA
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyParesthesia (Hands/ R Leg)
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyRadiation Fibrosis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyRib pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyRight Leg Pain Sciatica
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyRight Shoulder Pain
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyRight neck stiffness
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifySpinal SteNsis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specifyThroat Pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
20.5%
8/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
7.7%
3/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyAdrenal AdeNma
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Aphonia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Dizziness
|
22.0%
9/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
17.9%
7/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Dysgeusia
|
63.4%
26/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
79.5%
31/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Dysphasia
|
14.6%
6/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
10.3%
4/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Headache
|
19.5%
8/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
10.3%
4/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Movements involuntary
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Nervous system disorders - Other, specifyAutoNmic Insufficiency
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Nervous system disorders - Other, specifyNeuropathic pain
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Nervous system disorders - Other, specifyOdyNphagia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Nervous system disorders - Other, specifyPresyncope
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Nervous system disorders - Other, specifySPINAL STENSIS
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Nervous system disorders - Other, specifydysosmia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Nervous system disorders - Other, specifynumb right ear
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Neuralgia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Paresthesia
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
12.8%
5/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Presyncope
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Syncope
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Nervous system disorders
Tremor
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Psychiatric disorders
Anxiety
|
17.1%
7/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
10.3%
4/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Psychiatric disorders
Depression
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Psychiatric disorders
Hallucinations
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Psychiatric disorders
Insomnia
|
9.8%
4/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
7.7%
3/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Psychiatric disorders
Restlessness
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
7.7%
3/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specifyBenign Prostatic Hyperplasia
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specifyBenign prostatic hypertrophy
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.0%
9/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
20.5%
8/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
10.3%
4/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
19.5%
8/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
28.2%
11/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specifyCOPD
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specifyEmphysema
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specifyThroat erythema
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specifyUlceration oropharynx
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specifyUpper Respiratoty Infection
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specifylung Ndules
|
4.9%
2/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specifysob with exertion
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
31.7%
13/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
30.8%
12/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.3%
3/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
17.9%
7/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
5.1%
2/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.1%
7/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify65cm open area Rt neck
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specifyBruising periorbital
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specifyDermatitis of right lower extremity
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specifyErythema Throat
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specifyNeck wound
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specifyPuritic skin
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specifyTape Burn to abd area
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specifyrash
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specifyinfusion siite extravastion
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specifytracheostomy site bleeding
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specifytumor bleeding
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Flushing
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Hematoma
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Hypertension
|
34.1%
14/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
33.3%
13/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Hypotension
|
26.8%
11/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
17.9%
7/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Lymphedema
|
12.2%
5/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
17.9%
7/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Phlebitis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Superficial thrombophlebitis
|
2.4%
1/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
0.00%
0/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Vascular disorders - Other, specifyCoronary artery disease
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Vascular disorders - Other, specifyLeft Ventricle Hypertrophy
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Vascular disorders - Other, specifyVascular access complication
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
|
Vascular disorders
Vasculitis
|
0.00%
0/41 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
2.6%
1/39 • Up to 48 months
Common Terminology Criteria for Adverse Events CTCAE (4.0) Serious Adverse Events = Grade 3 or greater events Advertising Events = events less than Grade 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place