Trial Outcomes & Findings for Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement (NCT NCT00448864)
NCT ID: NCT00448864
Last Updated: 2019-06-25
Results Overview
Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Up to 12 hours post admission to intensive care unit (ICU)
Results posted on
2019-06-25
Participant Flow
Participant milestones
| Measure |
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
|
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
29
|
19
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
26
|
25
|
18
|
|
Overall Study
Started Post-operative Period
|
26
|
25
|
18
|
|
Overall Study
Completed Post-operative Period
|
26
|
25
|
18
|
|
Overall Study
COMPLETED
|
22
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
1
|
Reasons for withdrawal
| Measure |
Ecallantide - Low Dose Regimen
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
|
Ecallantide - High Dose Regimen
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
Baseline Characteristics
Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
Baseline characteristics by cohort
| Measure |
Total
n=69 Participants
Total of all reporting groups
|
Ecallantide - Low Dose Regimen
n=26 Participants
Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
|
Ecallantide - High Dose Regimen
n=25 Participants
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
n=18 Participants
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|---|
|
Age, Categorical
LTE18
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
BTWN
|
44 Participants
n=4 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
GTE65
|
25 Participants
n=4 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=4 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=4 Participants
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 hours post admission to intensive care unit (ICU)Population: All participants who received at least 1 dose of study drug.
Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
Outcome measures
| Measure |
Ecallantide - Low Dose Regimen
n=26 Participants
Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
|
Ecallantide - High Dose Regimen
n=25 Participants
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
n=18 Participants
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|
|
Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively
|
729.9 Milliliters
Standard Deviation 432.03
|
935.8 Milliliters
Standard Deviation 510.18
|
1400.7 Milliliters
Standard Deviation 1371.65
|
SECONDARY outcome
Timeframe: Up to 24 hours post admission to ICUPopulation: All participants who received at least 1 dose of study drug.
Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
Outcome measures
| Measure |
Ecallantide - Low Dose Regimen
n=26 Participants
Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
|
Ecallantide - High Dose Regimen
n=25 Participants
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
n=18 Participants
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|
|
Cumulative Chest Tube Drainage at 24 Hours Postoperatively
|
82.9 Milliliters
Standard Deviation 74.99
|
149.8 Milliliters
Standard Deviation 132.27
|
225.3 Milliliters
Standard Deviation 453.60
|
SECONDARY outcome
Timeframe: up to 28 days post admission to ICUPopulation: All participants who received at least 1 dose of study drug.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Ecallantide - Low Dose Regimen
n=26 Participants
Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
|
Ecallantide - High Dose Regimen
n=25 Participants
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
n=18 Participants
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
|
25 participants
|
23 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 1, 2, 4, and 8 hours after end of study drug infusionPopulation: All participants who received at least 1 dose of study drug.
Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg\*h/L)
Outcome measures
| Measure |
Ecallantide - Low Dose Regimen
n=26 Participants
Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
|
Ecallantide - High Dose Regimen
n=25 Participants
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Time Curve
|
1.39 mg*h/L
Standard Deviation 0.589
|
13.6 mg*h/L
Standard Deviation 3.58
|
—
|
Adverse Events
Ecallantide - Low Dose Regimen
Serious events: 9 serious events
Other events: 25 other events
Deaths: 0 deaths
Ecallantide - High Dose Regimen
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ecallantide - Low Dose Regimen
n=26 participants at risk
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
|
Ecallantide - High Dose Regimen
n=25 participants at risk
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
n=18 participants at risk
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|
|
Infections and infestations
Infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Infections and infestations
Wound infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Arrhythmia supraventricular
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Myocardial infarction
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Cardiac disorders
Ventricular tachycardia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Multi-organ failure
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
7.7%
2/26 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
International normalised ratio increased
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Cerebral infarction
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Nervous system disorders
Convulsion
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/26
|
0.00%
0/25
|
16.7%
3/18 • Number of events 3
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Vascular disorders
Hypotension
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Ecallantide - Low Dose Regimen
n=26 participants at risk
Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
|
Ecallantide - High Dose Regimen
n=25 participants at risk
Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
|
Placebo
n=18 participants at risk
Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.2%
5/26 • Number of events 6
|
24.0%
6/25 • Number of events 6
|
33.3%
6/18 • Number of events 6
|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
2/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
16.7%
3/18 • Number of events 3
|
|
Cardiac disorders
Angina pectoris
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Cardiac disorders
Atrial fibrillation
|
23.1%
6/26 • Number of events 6
|
20.0%
5/25 • Number of events 6
|
38.9%
7/18 • Number of events 10
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Cardiac disorders
Supraventricular tachycardia
|
7.7%
2/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/18
|
|
Cardiac disorders
Tachycardia
|
3.8%
1/26 • Number of events 1
|
20.0%
5/25 • Number of events 5
|
0.00%
0/18
|
|
Cardiac disorders
Ventricular extrasystoles
|
3.8%
1/26 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Retinal vascular thrombosis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Eye disorders
Vision blurred
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Number of events 3
|
24.0%
6/25 • Number of events 6
|
27.8%
5/18 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Gastrointestinal disorders
Haematochezia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1
|
20.0%
5/25 • Number of events 5
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1
|
12.0%
3/25 • Number of events 4
|
0.00%
0/18
|
|
General disorders
Chest pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
General disorders
Chills
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Crepitations
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
General disorders
Fatigue
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
General disorders
Generalised oedema
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Infusion site reaction
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Localised oedema
|
7.7%
2/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/18
|
|
General disorders
Oedema
|
7.7%
2/26 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
General disorders
Oedema peripheral
|
7.7%
2/26 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Pain
|
7.7%
2/26 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Pyrexia
|
19.2%
5/26 • Number of events 5
|
8.0%
2/25 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Candidiasis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Sepsis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Infections and infestations
Sinusitis
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
16.7%
3/18 • Number of events 3
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arterial injury
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/26
|
4.0%
1/25 • Number of events 2
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Incision site pain
|
15.4%
4/26 • Number of events 4
|
12.0%
3/25 • Number of events 3
|
16.7%
3/18 • Number of events 3
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
7.7%
2/26 • Number of events 2
|
16.0%
4/25 • Number of events 4
|
16.7%
3/18 • Number of events 3
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.5%
3/26 • Number of events 3
|
36.0%
9/25 • Number of events 9
|
27.8%
5/18 • Number of events 5
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
Blood albumin decreased
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood chloride increased
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Body temperature increased
|
11.5%
3/26 • Number of events 3
|
4.0%
1/25 • Number of events 3
|
0.00%
0/18
|
|
Investigations
Breath sounds abnormal
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
Cardiac enzymes increased
|
11.5%
3/26 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Cardiac murmur
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Electrocardiogram
|
3.8%
1/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Investigations
Haematocrit decreased
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Haemoglobin
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/26
|
12.0%
3/25 • Number of events 3
|
0.00%
0/18
|
|
Investigations
Heart rate decreased
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
Heart rate increased
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Mean arterial pressure decreased
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Investigations
Oxygen saturation normal
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
Platelet count decreased
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Investigations
Platelet count increased
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
Protein total decreased
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Thoracic cavity drainage test abnormal
|
11.5%
3/26 • Number of events 3
|
0.00%
0/25
|
0.00%
0/18
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Investigations
Urine output decreased
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
16.7%
3/18 • Number of events 3
|
|
Investigations
White blood cell count increased
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Electrolyte depletion
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Fluid overload
|
7.7%
2/26 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
1/26 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.7%
2/26 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
2/26 • Number of events 2
|
12.0%
3/25 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
2/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
11.5%
3/26 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Number of events 3
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Presyncope
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Somnolence
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Psychiatric disorders
Delirium
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Delusion
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26
|
0.00%
0/25
|
11.1%
2/18 • Number of events 2
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/26
|
8.0%
2/25 • Number of events 2
|
0.00%
0/18
|
|
Psychiatric disorders
Paranoia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Psychiatric disorders
Staring
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Renal and urinary disorders
Oliguria
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Renal and urinary disorders
Renal failure
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Renal and urinary disorders
Renal failure acute
|
7.7%
2/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/18
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
11.5%
3/26 • Number of events 3
|
12.0%
3/25 • Number of events 3
|
16.7%
3/18 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
23.1%
6/26 • Number of events 6
|
12.0%
3/25 • Number of events 3
|
33.3%
6/18 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.8%
1/26 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
2/26 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
|
Surgical and medical procedures
Incisional drainage
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/18
|
|
Surgical and medical procedures
Oxygen supplementation
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
3.8%
1/26 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
11.1%
2/18 • Number of events 2
|
|
Vascular disorders
Hypertension
|
15.4%
4/26 • Number of events 4
|
16.0%
4/25 • Number of events 4
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Hypotension
|
26.9%
7/26 • Number of events 8
|
28.0%
7/25 • Number of events 9
|
27.8%
5/18 • Number of events 6
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/26
|
0.00%
0/25
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/18
|
Additional Information
Vice President, Clinical Research
Cubist Pharmaceuticals
Phone: (781) 860-8660
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER