Trial Outcomes & Findings for Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer (NCT NCT02444741)
NCT ID: NCT02444741
Last Updated: 2026-05-15
Results Overview
Best out-of-field lesion response
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Median duration of follow-up 20.4 months (range of 1.4 to 30.2 months) for Phase 2
Results posted on
2026-05-15
Participant Flow
Dates of recruitment period: 09/2015 to 08/2018; Location: Phase 1/Phase 2 single center trial that recruited patients at one hospital (MD Anderson Cancer Center, Houston, TX)
Participant milestones
| Measure |
Phase 1, Group 1: SBRT + Pembrolizumab
SBRT total dose 50 Gy in 12.5 Gy fractions (4 fractions total) with Pembrolizumab 100 mg followed by 150 mg and 200 mg if the former dose tolerated
|
Phase 1, Group 2: WFRT + Pembrolizumab
WFRT total dose of 45 Gy in 3 fractions to PTV (15 fractions total) with Pembrolizumab 100 mg followed by 150 and 200 mg if the former dose tolerated
|
Phase II, Group 1: SBRT + Pembrolizumab
Pembrolizumab 200 mg IV every 3 wks and concurrent SBRT Arm (50 Gy in 4 fractions)
|
Phase II, Group 2: Pembrolizumab Alone (if PD Then SBRT + Pembrolizumab)
Pembrolizumab 200 mg every 3 wks; if PD, SBRT concurrent with remaining Pembrolizumab cycles
|
Phase II, Group 3: WFRT + Pembrolizumab
Pembrolizumab 200 mg IV every 3 wks and concurrent WFRT Arm (45 Gy in 15 fractions)
|
Phase II, Group 4: Pembrolizumab Alone (if PD Then WFRT + Pembrolizumab)
Pembrolizumab 200 mg IV every 3 wks; if PD, WFRT concurrent with remainting Pembrolizumab cycles
|
Phase II, Group V: SBRT or WFRT + Pembrolizumab + Low Dose XRT
SBRT or WFRT + Pembrolizumab; either 15 Fx to primary lesions and low dose RT to other lesions on D43-61 or SBRT in 4 fractions to primary lesions and low dose RT to other lesions on D44-47
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
19
|
21
|
21
|
19
|
1
|
|
Overall Study
COMPLETED
|
1
|
4
|
5
|
11
|
11
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
14
|
10
|
10
|
13
|
1
|
Reasons for withdrawal
| Measure |
Phase 1, Group 1: SBRT + Pembrolizumab
SBRT total dose 50 Gy in 12.5 Gy fractions (4 fractions total) with Pembrolizumab 100 mg followed by 150 mg and 200 mg if the former dose tolerated
|
Phase 1, Group 2: WFRT + Pembrolizumab
WFRT total dose of 45 Gy in 3 fractions to PTV (15 fractions total) with Pembrolizumab 100 mg followed by 150 and 200 mg if the former dose tolerated
|
Phase II, Group 1: SBRT + Pembrolizumab
Pembrolizumab 200 mg IV every 3 wks and concurrent SBRT Arm (50 Gy in 4 fractions)
|
Phase II, Group 2: Pembrolizumab Alone (if PD Then SBRT + Pembrolizumab)
Pembrolizumab 200 mg every 3 wks; if PD, SBRT concurrent with remaining Pembrolizumab cycles
|
Phase II, Group 3: WFRT + Pembrolizumab
Pembrolizumab 200 mg IV every 3 wks and concurrent WFRT Arm (45 Gy in 15 fractions)
|
Phase II, Group 4: Pembrolizumab Alone (if PD Then WFRT + Pembrolizumab)
Pembrolizumab 200 mg IV every 3 wks; if PD, WFRT concurrent with remainting Pembrolizumab cycles
|
Phase II, Group V: SBRT or WFRT + Pembrolizumab + Low Dose XRT
SBRT or WFRT + Pembrolizumab; either 15 Fx to primary lesions and low dose RT to other lesions on D43-61 or SBRT in 4 fractions to primary lesions and low dose RT to other lesions on D44-47
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
3
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
discontinued due to disease progression
|
2
|
0
|
0
|
1
|
4
|
4
|
0
|
|
Overall Study
discontinued due to disease progression/death
|
0
|
4
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
3
|
0
|
8
|
7
|
6
|
7
|
0
|
Baseline Characteristics
Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase 1, Group 1: SBRT + Pembrolizumab
n=10 Participants
SBRT total dose 50 Gy in 12.5 Gy fractions (4 fractions total) with Pembrolizumab 100 mg followed by 150 mg and 200 mg if the former dose tolerated
|
Phase 1, Group 2: WFRT + Pembrolizumab
n=10 Participants
WFRT total dose of 45 Gy in 3 fractions to PTV (15 fractions total) with Pembrolizumab 100 mg followed by 150 and 200 mg if the former dose tolerated
|
Phase II, Group 1: SBRT + Pembrolizumab
n=19 Participants
Pembrolizumab 200 mg IV every 3 wks and concurrent SBRT Arm (50 Gy in 4 fractions)
|
Phase II, Group 2: Pembrolizumab Alone (if PD Then SBRT + Pembrolizumab)
n=21 Participants
Pembrolizumab 200 mg every 3 wks; if PD, SBRT concurrent with remaining Pembrolizumab cycles
|
Phase II, Group 3: WFRT + Pembrolizumab
n=21 Participants
Pembrolizumab 200 mg IV every 3 wks and concurrent WFRT Arm (45 Gy in 15 fractions)
|
Phase II, Group 4: Pembrolizumab Alone (if PD Then WFRT + Pembrolizumab)
n=19 Participants
Pembrolizumab 200 mg IV every 3 wks; if PD, WFRT concurrent with remainting Pembrolizumab cycles
|
Phase II, Group V: SBRT or WFRT + Pembrolizumab + Low Dose XRT
n=1 Participants
SBRT or WFRT + Pembrolizumab; either 15 Fx to primary lesions and low dose RT to other lesions on D43-61 or SBRT in 4 fractions to primary lesions and low dose RT to other lesions on D44-47
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
7 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
13 Participants
n=20 Participants
|
16 Participants
n=186 Participants
|
13 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
1 Participants
n=122 Participants
|
65 Participants
n=2 Participants
|
|
Age, Continuous
|
65 years
n=11 Participants
|
65 years
n=9 Participants
|
68 years
n=20 Participants
|
70 years
n=186 Participants
|
63 years
n=12 Participants
|
63 years
n=12 Participants
|
74 years
n=122 Participants
|
65 years
n=2 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
6 Participants
n=20 Participants
|
5 Participants
n=186 Participants
|
8 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
36 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=186 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
8 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
19 Participants
n=20 Participants
|
18 Participants
n=186 Participants
|
18 Participants
n=12 Participants
|
18 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
87 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=122 Participants
|
6 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=186 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
6 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=186 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
8 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
15 Participants
n=20 Participants
|
17 Participants
n=186 Participants
|
18 Participants
n=12 Participants
|
16 Participants
n=12 Participants
|
1 Participants
n=122 Participants
|
86 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=11 Participants
|
10 participants
n=9 Participants
|
19 participants
n=20 Participants
|
21 participants
n=186 Participants
|
21 participants
n=12 Participants
|
19 participants
n=12 Participants
|
1 participants
n=122 Participants
|
101 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Median duration of follow-up 20.4 months (range of 1.4 to 30.2 months) for Phase 2Population: ORR for Phase 1, Groups 1 and 2 is not applicable as Phase 1 part of trial only determining safety and maximum tolerated dose via toxicities and progression free survival.
Best out-of-field lesion response
Outcome measures
| Measure |
Phase 1, Group 1: SBRT + Pembrolizumab
SBRT total dose 50 Gy in 12.5 Gy fractions (4 fractions total) with Pembrolizumab 100 mg followed by 150 mg and 200 mg if the former dose tolerated
|
Phase 1, Group 2: WFRT + Pembrolizumab + Concurrent SBRT Arm
WFRT total dose of 45 Gy in 3 fractions to PTV (15 fractions total) with Pembrolizumab 100 mg followed by 150 and 200 mg if the former dose tolerated
|
Phase II, Group 1: SBRT + Pembrolizumab
n=19 Participants
Pembrolizumab 200 mg IV every 3 wks and concurrent SBRT Arm (50 Gy in 4 fractions)
|
Phase II, Group 2: Pembrolizumab Alone (if PD Then SBRT + Pembrolizumab)
n=21 Participants
Pembrolizumab 200 mg every 3 wks; if PD, SBRT concurrent with remaining Pembrolizumab cycles
|
Phase II, Group 3: WFRT + Pembrolizumab (+/- Salvage Traditional RT)
n=21 Participants
Pembrolizumab 200 mg IV every 3 wks and concurrent WFRT Arm (45 Gy in 15 fractions)
|
Phase II, Group 4: Pembrolizumab Alone (if PD Then WFRT + Pembrolizumab)
n=19 Participants
Pembrolizumab 200 mg IV every 3 wks; if PD, WFRT concurrent with remainting Pembrolizumab cycles
|
Phase II, Group V: SBRT or WFRT + Pembrolizumab + Low Dose XRT
n=1 Participants
SBRT or WFRT + Pembrolizumab; either 15 Fx to primary lesions and low dose RT to other lesions on D43-61 or SBRT in 4 fractions to primary lesions and low dose RT to other lesions on D44-47
|
|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
—
|
—
|
38 ORR Percentage of participants whose tum
|
33 ORR Percentage of participants whose tum
|
10 ORR Percentage of participants whose tum
|
17 ORR Percentage of participants whose tum
|
100 ORR Percentage of participants whose tum
|
SECONDARY outcome
Timeframe: Median duration of follow-up 20.4 months (range of 1.4 to 30.2 months)Time not experiencing progression after time of treatment initiation (first cycle of pembrolizumab or RT, whichever came first) and determined after consecutive imaging to determine if an increase in tumor burden was present
Outcome measures
| Measure |
Phase 1, Group 1: SBRT + Pembrolizumab
n=10 Participants
SBRT total dose 50 Gy in 12.5 Gy fractions (4 fractions total) with Pembrolizumab 100 mg followed by 150 mg and 200 mg if the former dose tolerated
|
Phase 1, Group 2: WFRT + Pembrolizumab + Concurrent SBRT Arm
n=10 Participants
WFRT total dose of 45 Gy in 3 fractions to PTV (15 fractions total) with Pembrolizumab 100 mg followed by 150 and 200 mg if the former dose tolerated
|
Phase II, Group 1: SBRT + Pembrolizumab
n=19 Participants
Pembrolizumab 200 mg IV every 3 wks and concurrent SBRT Arm (50 Gy in 4 fractions)
|
Phase II, Group 2: Pembrolizumab Alone (if PD Then SBRT + Pembrolizumab)
n=21 Participants
Pembrolizumab 200 mg every 3 wks; if PD, SBRT concurrent with remaining Pembrolizumab cycles
|
Phase II, Group 3: WFRT + Pembrolizumab (+/- Salvage Traditional RT)
n=21 Participants
Pembrolizumab 200 mg IV every 3 wks and concurrent WFRT Arm (45 Gy in 15 fractions)
|
Phase II, Group 4: Pembrolizumab Alone (if PD Then WFRT + Pembrolizumab)
n=19 Participants
Pembrolizumab 200 mg IV every 3 wks; if PD, WFRT concurrent with remainting Pembrolizumab cycles
|
Phase II, Group V: SBRT or WFRT + Pembrolizumab + Low Dose XRT
n=1 Participants
SBRT or WFRT + Pembrolizumab; either 15 Fx to primary lesions and low dose RT to other lesions on D43-61 or SBRT in 4 fractions to primary lesions and low dose RT to other lesions on D44-47
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
7.7 Number of months
Interval 4.1 to 17.9
|
6.1 Number of months
Interval 4.1 to 26.0
|
9.1 Number of months
Interval 3.6 to 18.4
|
5.1 Number of months
Interval 3.4 to 12.7
|
9.1 Number of months
Interval 3.6 to 18.4
|
5.1 Number of months
Interval 3.4 to 12.7
|
12.2 Number of months
Not applicable as 95% confidence interval cannot be determined as sample size is 1
|
Adverse Events
Phase 1, Group 1: SBRT + Pembrolizumab
Serious events: 3 serious events
Other events: 10 other events
Deaths: 3 deaths
Phase 1, Group 2: WFRT + Pembrolizumab
Serious events: 3 serious events
Other events: 9 other events
Deaths: 4 deaths
Phase II, Group 1: SBRT + Pembrolizumab
Serious events: 4 serious events
Other events: 15 other events
Deaths: 8 deaths
Phase II, Group 2: Pembrolizumab Alone (if PD Then SBRT + Pembrolizumab)
Serious events: 8 serious events
Other events: 21 other events
Deaths: 7 deaths
Phase II, Group 3: WFRT + Pembrolizumab
Serious events: 7 serious events
Other events: 21 other events
Deaths: 6 deaths
Phase II, Group 4: Pembrolizumab Alone (if PD Then WFRT + Pembrolizumab)
Serious events: 3 serious events
Other events: 19 other events
Deaths: 7 deaths
Phase II, Group V: SBRT or WFRT + Pembrolizumab + Low Dose XRT
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1, Group 1: SBRT + Pembrolizumab
n=10 participants at risk
SBRT total dose 50 Gy in 12.5 Gy fractions (4 fractions total) with Pembrolizumab 100 mg followed by 150 mg and 200 mg if the former dose tolerated
|
Phase 1, Group 2: WFRT + Pembrolizumab
n=10 participants at risk
WFRT total dose of 45 Gy in 3 fractions to PTV (15 fractions total) with Pembrolizumab 100 mg followed by 150 and 200 mg if the former dose tolerated
|
Phase II, Group 1: SBRT + Pembrolizumab
n=19 participants at risk
Pembrolizumab 200 mg IV every 3 wks and concurrent SBRT Arm (50 Gy in 4 fractions)
|
Phase II, Group 2: Pembrolizumab Alone (if PD Then SBRT + Pembrolizumab)
n=21 participants at risk
Pembrolizumab 200 mg every 3 wks; if PD, SBRT concurrent with remaining Pembrolizumab cycles
|
Phase II, Group 3: WFRT + Pembrolizumab
n=21 participants at risk
Pembrolizumab 200 mg IV every 3 wks and concurrent WFRT Arm (45 Gy in 15 fractions)
|
Phase II, Group 4: Pembrolizumab Alone (if PD Then WFRT + Pembrolizumab)
n=19 participants at risk
Pembrolizumab 200 mg IV every 3 wks; if PD, WFRT concurrent with remainting Pembrolizumab cycles
|
Phase II, Group V: SBRT or WFRT + Pembrolizumab + Low Dose XRT
n=1 participants at risk
SBRT or WFRT + Pembrolizumab; either 15 Fx to primary lesions and low dose RT to other lesions on D43-61 or SBRT in 4 fractions to primary lesions and low dose RT to other lesions on D44-47
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Right Ventricular Dysfunction
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonytis
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
AST Elevation
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
ALT Elevation
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Rash, Maculopapular
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Mucositis
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Pain
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Fatigue
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pruritis
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
20.0%
2/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
Other adverse events
| Measure |
Phase 1, Group 1: SBRT + Pembrolizumab
n=10 participants at risk
SBRT total dose 50 Gy in 12.5 Gy fractions (4 fractions total) with Pembrolizumab 100 mg followed by 150 mg and 200 mg if the former dose tolerated
|
Phase 1, Group 2: WFRT + Pembrolizumab
n=10 participants at risk
WFRT total dose of 45 Gy in 3 fractions to PTV (15 fractions total) with Pembrolizumab 100 mg followed by 150 and 200 mg if the former dose tolerated
|
Phase II, Group 1: SBRT + Pembrolizumab
n=19 participants at risk
Pembrolizumab 200 mg IV every 3 wks and concurrent SBRT Arm (50 Gy in 4 fractions)
|
Phase II, Group 2: Pembrolizumab Alone (if PD Then SBRT + Pembrolizumab)
n=21 participants at risk
Pembrolizumab 200 mg every 3 wks; if PD, SBRT concurrent with remaining Pembrolizumab cycles
|
Phase II, Group 3: WFRT + Pembrolizumab
n=21 participants at risk
Pembrolizumab 200 mg IV every 3 wks and concurrent WFRT Arm (45 Gy in 15 fractions)
|
Phase II, Group 4: Pembrolizumab Alone (if PD Then WFRT + Pembrolizumab)
n=19 participants at risk
Pembrolizumab 200 mg IV every 3 wks; if PD, WFRT concurrent with remainting Pembrolizumab cycles
|
Phase II, Group V: SBRT or WFRT + Pembrolizumab + Low Dose XRT
n=1 participants at risk
SBRT or WFRT + Pembrolizumab; either 15 Fx to primary lesions and low dose RT to other lesions on D43-61 or SBRT in 4 fractions to primary lesions and low dose RT to other lesions on D44-47
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash, pustular
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
15.8%
3/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Fatigue
|
60.0%
6/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
60.0%
6/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
31.6%
6/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
57.1%
12/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
14.3%
3/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
31.6%
6/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Malaise
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Anorexia
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
20.0%
2/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
23.8%
5/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
14.3%
3/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
21.1%
4/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
14.3%
3/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Pain
|
40.0%
4/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
70.0%
7/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
14.3%
3/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Chills
|
30.0%
3/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Weight loss
|
40.0%
4/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Dysgeusia
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Dehydration
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Headache
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Flu-like Illness
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Rash, maculopapular
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
26.3%
5/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
28.6%
6/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
42.1%
8/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Rash, Acneform
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
15.8%
3/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Erythema Multiform
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
15.8%
3/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Cardiac disorders
Hypotension
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Rash, urticarial
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
30.0%
3/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
60.0%
6/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
15.8%
3/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
14.3%
3/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
6/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
50.0%
5/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
14.3%
3/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
2/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Infection
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
2/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
19.0%
4/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
40.0%
4/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
20.0%
2/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.5%
2/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
14.3%
3/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
AST Elevation
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
ALT Elevation
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Renal and urinary disorders
Creatinine Elevation
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
Hyponatremia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
Hyperkalemia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
9.5%
2/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
Hypokalemia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
20.0%
2/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
Hypercalcemia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
Investigations
Hyperlipidemia
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Thyroiditis
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Hypothyroidism
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.0%
1/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
4.8%
1/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
10.5%
2/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
100.0%
1/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
|
General disorders
Hyperthyroidism
|
20.0%
2/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/10 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/21 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
5.3%
1/19 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
0.00%
0/1 • Baseline to median of 20.4 months (range, 1.4 to 30.2 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place