Trial Outcomes & Findings for Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease (NCT NCT02843165)
NCT ID: NCT02843165
Last Updated: 2025-09-30
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
Responses measured by RECIST at 16 weeks from baseline
Results posted on
2025-09-30
Participant Flow
Participants were recruited at the Moores Cancer Center of the University of California San Diego
Participant milestones
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
48
|
|
Overall Study
COMPLETED
|
58
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease
Baseline characteristics by cohort
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
n=58 Participants
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
n=48 Participants
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.03 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
63 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
61.92 years
STANDARD_DEVIATION 12.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Body System
Breast
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Body System
Gastrointestinal
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Body System
Genitourinary
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Body System
Gynecologic
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Body System
Head and Neck
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Body System
Musculoskeletal
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Body System
Respiratory
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Body System
Skin
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body System
Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Responses measured by RECIST at 16 weeks from baselinePopulation: All participants who received at least one cycle of checkpoint blockade immunotherapy with or without SBRT
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
n=58 Participants
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
n=48 Participants
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
|---|---|---|
|
Objective Response Rate
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: All participants who received at least one cycle of checkpoint blockade immunotherapy with or without SBRT
Adverse events assessed from time of first dose to treatment completion (approximately 1 year)
Outcome measures
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
n=58 Participants
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
n=48 Participants
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
|---|---|---|
|
Number of Participants With Adverse Events
|
58 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Assessed at 5 yearsPopulation: All participants who received at least one cycle of checkpoint blockade immunotherapy with or without SBRT
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
n=58 Participants
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
n=48 Participants
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
|---|---|---|
|
Progression Free Survival
|
2.38 months
Interval 1.95 to 3.37
|
1.88 months
Interval 1.82 to 2.81
|
SECONDARY outcome
Timeframe: Assessed at 5 yearsPopulation: All participants who received at least one cycle of checkpoint blockade immunotherapy with or without SBRT
The time from starting treatment until death due to any cause.
Outcome measures
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
n=58 Participants
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
n=48 Participants
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
|---|---|---|
|
Overall Survival
|
14.1 months
Interval 8.46 to 25.2
|
12.6 months
Interval 7.14 to 29.2
|
SECONDARY outcome
Timeframe: Assessed at 5 yearsPopulation: All participants who received at least one cycle of checkpoint blockade immunotherapy with or without SBRT
The rates of stable disease great than or equal to 6 months during and after SBRT in combination with CBI compared to CBI alone.
Outcome measures
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
n=58 Participants
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
n=48 Participants
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
|---|---|---|
|
Rate of Stable Disease
|
7 Participants
|
4 Participants
|
Adverse Events
Checkpoint Blockade Immunotherapy Plus SBRT
Serious events: 24 serious events
Other events: 44 other events
Deaths: 36 deaths
Checkpoint Blockade Immunotherapy
Serious events: 15 serious events
Other events: 35 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
n=58 participants at risk
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
n=48 participants at risk
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Cardiac disorders
atrial fibrillation
|
3.4%
2/58 • Number of events 2 • 5 years
|
0.00%
0/48 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Cardiac disorders
ventricular fibrillation
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
1/58 • Number of events 1 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • Number of events 1 • 5 years
|
10.4%
5/48 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/58 • 5 years
|
6.2%
3/48 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/58 • 5 years
|
4.2%
2/48 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
2/58 • Number of events 2 • 5 years
|
10.4%
5/48 • Number of events 5 • 5 years
|
|
General disorders
Edema limbs
|
1.7%
1/58 • Number of events 2 • 5 years
|
0.00%
0/48 • 5 years
|
|
General disorders
Fatigue
|
3.4%
2/58 • Number of events 2 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
General disorders
Pain
|
3.4%
2/58 • Number of events 2 • 5 years
|
0.00%
0/48 • 5 years
|
|
Infections and infestations
Infections and infestations - Other
|
1.7%
1/58 • Number of events 1 • 5 years
|
4.2%
2/48 • Number of events 2 • 5 years
|
|
Infections and infestations
Joint infection
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Infections and infestations
Sepsis
|
1.7%
1/58 • Number of events 1 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Infections and infestations
Skin infection
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • Number of events 1 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
2/58 • Number of events 2 • 5 years
|
0.00%
0/48 • 5 years
|
|
Investigations
Blood bilirubin increased
|
3.4%
2/58 • Number of events 3 • 5 years
|
0.00%
0/48 • 5 years
|
|
Investigations
Creatinine increased
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/58 • Number of events 2 • 5 years
|
0.00%
0/48 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/58 • Number of events 2 • 5 years
|
0.00%
0/48 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Nervous system disorders
Syncope
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Confusion
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.2%
3/58 • Number of events 3 • 5 years
|
0.00%
0/48 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/58 • 5 years
|
6.2%
3/48 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
2/58 • Number of events 4 • 5 years
|
6.2%
3/48 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
2/58 • Number of events 4 • 5 years
|
0.00%
0/48 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/58 • Number of events 1 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/58 • Number of events 1 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Vascular disorders
Hematoma
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/58 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
8.6%
5/58 • Number of events 5 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Checkpoint Blockade Immunotherapy Plus SBRT
n=58 participants at risk
Checkpoint blockade immunotherapy (CBI) plus stereotactic body radiation therapy (SBRT)
Checkpoint blockade immunotherapy plus SBRT: SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
Checkpoint Blockade Immunotherapy
n=48 participants at risk
Checkpoint blockade immunotherapy (CBI) alone
Checkpoint blockade immunotherapy: Approved Checkpoint blockade immunotherapy (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
3.4%
2/58 • Number of events 4 • 5 years
|
2.1%
1/48 • Number of events 2 • 5 years
|
|
Cardiac disorders
CARDIAC DISORDERS
|
8.6%
5/58 • Number of events 8 • 5 years
|
4.2%
2/48 • Number of events 2 • 5 years
|
|
Ear and labyrinth disorders
EAR AND LABYRINTH DISORDERS
|
5.2%
3/58 • Number of events 4 • 5 years
|
4.2%
2/48 • Number of events 2 • 5 years
|
|
Endocrine disorders
ENDOCRINE DISORDERS
|
10.3%
6/58 • Number of events 6 • 5 years
|
8.3%
4/48 • Number of events 5 • 5 years
|
|
Eye disorders
EYE DISORDERS
|
5.2%
3/58 • Number of events 3 • 5 years
|
4.2%
2/48 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
39.7%
23/58 • Number of events 45 • 5 years
|
31.2%
15/48 • Number of events 19 • 5 years
|
|
General disorders
GENERAL DISORDERS
|
36.2%
21/58 • Number of events 33 • 5 years
|
33.3%
16/48 • Number of events 30 • 5 years
|
|
Immune system disorders
IMMUNE SYSTEM DISORDERS
|
1.7%
1/58 • Number of events 1 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
5.2%
3/58 • Number of events 4 • 5 years
|
14.6%
7/48 • Number of events 7 • 5 years
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
|
1.7%
1/58 • Number of events 1 • 5 years
|
0.00%
0/48 • 5 years
|
|
Investigations
INVESTIGATIONS
|
15.5%
9/58 • Number of events 20 • 5 years
|
12.5%
6/48 • Number of events 14 • 5 years
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS
|
13.8%
8/58 • Number of events 12 • 5 years
|
6.2%
3/48 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
|
25.9%
15/58 • Number of events 23 • 5 years
|
12.5%
6/48 • Number of events 9 • 5 years
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS
|
13.8%
8/58 • Number of events 9 • 5 years
|
6.2%
3/48 • Number of events 4 • 5 years
|
|
Psychiatric disorders
PSYCHIATRIC DISORDERS
|
8.6%
5/58 • Number of events 5 • 5 years
|
2.1%
1/48 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS
|
6.9%
4/58 • Number of events 4 • 5 years
|
4.2%
2/48 • Number of events 2 • 5 years
|
|
Reproductive system and breast disorders
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
|
1.7%
1/58 • Number of events 1 • 5 years
|
4.2%
2/48 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
|
20.7%
12/58 • Number of events 22 • 5 years
|
14.6%
7/48 • Number of events 9 • 5 years
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
27.6%
16/58 • Number of events 26 • 5 years
|
27.1%
13/48 • Number of events 14 • 5 years
|
|
Vascular disorders
VASCULAR DISORDERS
|
12.1%
7/58 • Number of events 7 • 5 years
|
4.2%
2/48 • Number of events 2 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place