Trial Outcomes & Findings for 99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis (NCT NCT03232580)
NCT ID: NCT03232580
Last Updated: 2019-12-13
Results Overview
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results. Uptake compared with background (e.g. physiological liver uptake) were assessed for each affected area by nuclear medicine physicians using a 4-grade scoring system (e.g. 0, none; 1, mild or present but \< to background uptake; 2, moderate or = to background uptake; 3, intense or \> to background uptake). Only descriptive analysis performed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
60 minutes and 120 minutes post investigational product adminstration
Results posted on
2019-12-13
Participant Flow
5 patients enrolled single site in US
Participant milestones
| Measure |
rhAnnexin V-128
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
Baseline characteristics by cohort
| Measure |
rhAnnexin V-128
n=5 Participants
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=5 Participants
|
|
Participants with Magnetic Resonance Imaging (MRI) results at Screening
MRI Results in Lumbar Spine · Negative
|
4 Participants
n=5 Participants
|
|
Participants with Magnetic Resonance Imaging (MRI) results at Screening
MRI Results in Lumbar Spine · Positive
|
1 Participants
n=5 Participants
|
|
Participants with Magnetic Resonance Imaging (MRI) results at Screening
MRI Results in Sacroiliac Joints · Negative
|
4 Participants
n=5 Participants
|
|
Participants with Magnetic Resonance Imaging (MRI) results at Screening
MRI Results in Sacroiliac Joints · Positive
|
1 Participants
n=5 Participants
|
|
Participants with Clinical Pain at Screening
Clinical Pain in Lumbar Spine · Yes
|
5 Participants
n=5 Participants
|
|
Participants with Clinical Pain at Screening
Clinical Pain in Lumbar Spine · No
|
0 Participants
n=5 Participants
|
|
Participants with Clinical Pain at Screening
Clinical Pain in Sacroiliac Joints · Yes
|
5 Participants
n=5 Participants
|
|
Participants with Clinical Pain at Screening
Clinical Pain in Sacroiliac Joints · No
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 minutes and 120 minutes post investigational product adminstrationPopulation: Only participants with a grading uptake at any given body region are included in the analysis
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results. Uptake compared with background (e.g. physiological liver uptake) were assessed for each affected area by nuclear medicine physicians using a 4-grade scoring system (e.g. 0, none; 1, mild or present but \< to background uptake; 2, moderate or = to background uptake; 3, intense or \> to background uptake). Only descriptive analysis performed.
Outcome measures
| Measure |
rhAnnexin V-128
n=5 Participants
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
|
|---|---|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Principal Inv. · Grade of uptake = 2
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Reviewer 2 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Principal Inv. · Grade of uptake = 0
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Principal Inv. · Grade of uptake = 0
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Reviewer 2 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Principal Inv. · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Reviewer 1 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Principal Inv. · Grade of uptake = 2
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Reviewer 2 · Grade of uptake = 0
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Principal Inv. · Grade of uptake = 0
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Principal Inv. · Grade of uptake = 1
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Principal Inv. · Grade of uptake = 2
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Principal Inv. · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Reviewer 1 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Reviewer 1 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Reviewer 1 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Principal Inv. · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Reviewer 1 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Reviewer 2 · Grade of uptake = 0
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Reviewer 2 · Grade of uptake = 1
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Whole Body Planar - Reviewer 2 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Reviewer 1 · Grade of uptake = 0
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Reviewer 1 · Grade of uptake = 1
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Reviewer 2 · Grade of uptake = 1
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Reviewer 2 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Reviewer 1 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Reviewer 2 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Principal Inv. · Grade of uptake = 0
|
4 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Principal Inv. · Grade of uptake = 1
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Reviewer 1 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Reviewer 2 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Principal Inv. · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Principal Inv. · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Reviewer 1 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Reviewer 1 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Reviewer 1 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Reviewer 1 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Reviewer 2 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Reviewer 2 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Reviewer 2 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Abdomen - Reviewer 2 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Principal Inv. · Grade of uptake = 0
|
4 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Principal Inv. · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Principal Inv. · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Reviewer 1 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Reviewer 1 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Reviewer 1 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Reviewer 1 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Reviewer 2 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Reviewer 2 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Reviewer 2 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Abdomen - Reviewer 2 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Principal Inv. · Grade of uptake = 0
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Principal Inv. · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Principal Inv. · Grade of uptake = 2
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Principal Inv. · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Reviewer 1 · Grade of uptake = 0
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Reviewer 1 · Grade of uptake = 1
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Reviewer 1 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Reviewer 1 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Reviewer 2 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Reviewer 2 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Reviewer 2 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Lumbosacral - Reviewer 2 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Principal Inv. · Grade of uptake = 1
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Principal Inv. · Grade of uptake = 2
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Principal Inv. · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Reviewer 1 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Reviewer 1 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Whole Body Planar - Reviewer 1 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Reviewer 2 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Reviewer 2 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Lumbosacral - Reviewer 2 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Principal Inv. · Grade of uptake = 0
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Principal Inv. · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Principal Inv. · Grade of uptake = 2
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Principal Inv. · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Reviewer 1 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Reviewer 1 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Reviewer 1 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Reviewer 1 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Reviewer 2 · Grade of uptake = 0
|
4 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Reviewer 2 · Grade of uptake = 1
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Reviewer 1 · Grade of uptake = 0
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Reviewer 1 · Grade of uptake = 1
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Reviewer 1 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
60 minutes: Sacroiliac Joint - Reviewer 2 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Reviewer 1 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Reviewer 2 · Grade of uptake = 0
|
4 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Reviewer 2 · Grade of uptake = 1
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Reviewer 2 · Grade of uptake = 2
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Reviewer 2 · Grade of uptake = 3
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Principal Inv. · Grade of uptake = 0
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Principal Inv. · Grade of uptake = 1
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Principal Inv. · Grade of uptake = 2
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake
120 minutes: Sacroiliac Joint - Principal Inv. · Grade of uptake = 3
|
0 Participants
|
PRIMARY outcome
Timeframe: 60 minutes and 120 minutes post investigational product adminstrationIn order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results. In case of discrepancies between the different readers, an adjudication process based on consensus was put in place in order to obtain one final outcome for each area. Adjudication results were categorized as Positive or Negative. Only descriptive analysis performed.
Outcome measures
| Measure |
rhAnnexin V-128
n=5 Participants
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
|
|---|---|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Sacroiliac - 60 minutes · Negative
|
4 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Whole Body Planar - 120 minutes · Negative
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Whole Body Planar - 60 minutes · Positive
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Abdomen - 60 minutes · Positive
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Abdomen - 60 minutes · Negative
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Lumbosacral - 60 minutes · Negative
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Abdomen - 120 minutes · Positive
|
0 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Lumbosacral - 120 minutes · Positive
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Lumbosacral - 120 minutes · Negative
|
3 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Sacroiliac - 60 minutes · Positive
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Sacroiliac - 120 minutes · Positive
|
1 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Sacroiliac - 120 minutes · Negative
|
4 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Abdomen - 120 minutes · Negative
|
5 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Lumbosacral - 60 minutes · Positive
|
2 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Whole Body Planar - 60 minutes · Negative
|
4 Participants
|
|
99mTc-rhAnnexin V-128 Uptake Adjudication
Whole Body Planar - 120 minutes · Positive
|
2 Participants
|
Adverse Events
rhAnnexin V-128
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rhAnnexin V-128
n=5 participants at risk
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
|
|---|---|
|
Injury, poisoning and procedural complications
Nausea
|
20.0%
1/5 • Number of events 1 • Adverse event were collected from first dosing (single administration, Day 0) plus 30 days post-treatment.
Any signs or symptom that occurs during the study treatment plus 30 days post-treatment.
|
|
Injury, poisoning and procedural complications
Itching at injection site
|
20.0%
1/5 • Number of events 1 • Adverse event were collected from first dosing (single administration, Day 0) plus 30 days post-treatment.
Any signs or symptom that occurs during the study treatment plus 30 days post-treatment.
|
|
Injury, poisoning and procedural complications
Redness at injection site
|
20.0%
1/5 • Number of events 1 • Adverse event were collected from first dosing (single administration, Day 0) plus 30 days post-treatment.
Any signs or symptom that occurs during the study treatment plus 30 days post-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Head cold
|
20.0%
1/5 • Number of events 1 • Adverse event were collected from first dosing (single administration, Day 0) plus 30 days post-treatment.
Any signs or symptom that occurs during the study treatment plus 30 days post-treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER