Trial Outcomes & Findings for Maintenance of Platelet Inhibition With Cangrelor (NCT NCT00767507)
NCT ID: NCT00767507
Last Updated: 2014-04-04
Results Overview
Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
221 participants
Primary outcome timeframe
During study drug infusion up to 1-6 hours prior to surgery
Results posted on
2014-04-04
Participant Flow
This study enrolled patients with acute coronary syndrome (ACS) or who had previously received stents, who were required to discontinue maintenance oral P2Y12 therapy before cardiac surgery. Patients who had discontinued oral therapy within the previous 72 hours were eligible. Patients were hospitalized during the enrollment period.
Stage I was an open-label, dose-finding stage to identify the dose of cangrelor that achieved a level of antiplatelet effect after discontinuation of oral P2Y12 therapy equivalent to the previous oral P2Y12 maintenance therapy. These patients were not enrolled in Stage II. Stage II was randomized, double-blind, placebo-controlled.
Participant milestones
| Measure |
Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage II - Cangrelor Arm (0.75 mcg/kg/Min )
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage II - Placebo Arm
Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
106
|
104
|
|
Overall Study
COMPLETED
|
5
|
6
|
106
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maintenance of Platelet Inhibition With Cangrelor
Baseline characteristics by cohort
| Measure |
Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor
n=5 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor
n=6 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage II Cangrelor Arm (0.75 mcg/kg/Min)
n=106 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage II Placebo Arm
n=101 Participants
Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
163 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
66 participants
n=5 Participants
|
59 participants
n=4 Participants
|
136 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Region of Enrollment
Czech Republic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
26 participants
n=5 Participants
|
29 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
4 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During study drug infusion up to 1-6 hours prior to surgeryEndpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).
Outcome measures
| Measure |
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=17 samples
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=18 samples
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.
|
76.5 percentage of samples
|
94.4 percentage of samples
|
—
|
—
|
PRIMARY outcome
Timeframe: During study drug infusion up to 1-6 hours prior to surgeryPopulation: Based on available data from ITT population; ITT population (Cangrelor N = 93) / (Placebo N = 90). Valid PRU results were not available during the infusion period for 15 patients (9 cangrelor and 6 placebo).
This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events. Patients had multiple samples and all "on-infusion" samples had to be \<240 PRU to meet the endpoint.
Outcome measures
| Measure |
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=84 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=84 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.
|
98.8 Percent of patients
|
19.0 Percent of patients
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline until just prior to surgery (post infusion)This endpoint analyzed the percent of patients with platelet reactivity \< 240 PRU at the following timepoints: * Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition) * Last sample during infusion * Following discontinuation of study drug infusion
Outcome measures
| Measure |
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=93 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=90 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU
Prior to study drug infusion (washout period)
|
62.4 percent of patients
|
52.3 percent of patients
|
—
|
—
|
|
Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU
Last sample during infusion
|
98.8 percent of patients
|
31.0 percent of patients
|
—
|
—
|
|
Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU
Following discontinuation of study drug infusion
|
26.9 percent of patients
|
20.0 percent of patients
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization through Hospital dischargePopulation: This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.
Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of \>1.5 liters (L), and/or packed red blood cell transfusions \> 4 units
Outcome measures
| Measure |
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=102 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=96 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=5 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=6 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding
|
12 Patients
|
10 Patients
|
0 Patients
|
1 Patients
|
SECONDARY outcome
Timeframe: Randomization until start of CABG surgeryPopulation: This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.
Outcome measures
| Measure |
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=102 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=96 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=5 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=6 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild
GUSTO severe/life threatening
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild
GUSTO moderate
|
10 participants
|
4 participants
|
0 participants
|
2 participants
|
|
Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild
GUSTO mild
|
8 participants
|
5 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Through 7 days or hospital discharge, whichever was soonerOutcome measures
| Measure |
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=106 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=101 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=5 Participants
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=6 Participants
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner
|
34 patients
|
35 patients
|
1 patients
|
4 patients
|
Adverse Events
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage II - Cangrelor Arm (0.75 mcg/kg/Min)
Serious events: 11 serious events
Other events: 27 other events
Deaths: 0 deaths
Stage II - Placebo Arm
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=5 participants at risk
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=6 participants at risk
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage II - Cangrelor Arm (0.75 mcg/kg/Min)
n=106 participants at risk
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage II - Placebo Arm
n=101 participants at risk
Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Cardiac disorders
angina pectoris
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/106
|
0.99%
1/101
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/5
|
0.00%
0/6
|
2.8%
3/106
|
0.99%
1/101
|
|
Cardiac disorders
cardiac asthma
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/106
|
0.99%
1/101
|
|
Cardiac disorders
cardiac failure
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/106
|
2.0%
2/101
|
|
Cardiac disorders
cardiogenic shock
|
0.00%
0/5
|
0.00%
0/6
|
3.8%
4/106
|
0.99%
1/101
|
|
Cardiac disorders
cardiopulmonary failure
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/106
|
0.99%
1/101
|
|
Cardiac disorders
coronary artery thrombosis
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Cardiac disorders
papillary muscle rupture
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Cardiac disorders
ventricular arrhythmia
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
General disorders
chest pain
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
General disorders
multi-organ failure
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/106
|
0.99%
1/101
|
|
General disorders
systemic inflammatory response syndrome
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Infections and infestations
abdominal sepsis
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/106
|
0.99%
1/101
|
|
Infections and infestations
beta haemolytic streptococcal infection
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Infections and infestations
gastroenteritis norovirus
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/106
|
0.99%
1/101
|
|
Infections and infestations
mediastinitis
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Injury, poisoning and procedural complications
vasoplegia syndrome
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Renal and urinary disorders
renal failure acute
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/5
|
0.00%
0/6
|
1.9%
2/106
|
0.99%
1/101
|
|
Vascular disorders
arterial thrombosis limb
|
0.00%
0/5
|
0.00%
0/6
|
0.94%
1/106
|
0.00%
0/101
|
Other adverse events
| Measure |
Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min
n=5 participants at risk
Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min
n=6 participants at risk
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage II - Cangrelor Arm (0.75 mcg/kg/Min)
n=106 participants at risk
Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
Stage II - Placebo Arm
n=101 participants at risk
Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
|
|---|---|---|---|---|
|
Cardiac disorders
angina pectoris
|
0.00%
0/5
|
16.7%
1/6
|
2.8%
3/106
|
0.00%
0/101
|
|
Injury, poisoning and procedural complications
overdose
|
0.00%
0/5
|
0.00%
0/6
|
1.9%
2/106
|
5.0%
5/101
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/106
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/5
|
33.3%
2/6
|
1.9%
2/106
|
0.00%
0/101
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/5
|
16.7%
1/6
|
0.94%
1/106
|
5.0%
5/101
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/106
|
2.0%
2/101
|
|
Cardiac disorders
tachycardia
|
0.00%
0/5
|
16.7%
1/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Gastrointestinal disorders
ileus
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/106
|
0.00%
0/101
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/5
|
16.7%
1/6
|
9.4%
10/106
|
3.0%
3/101
|
|
Gastrointestinal disorders
toothache
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/106
|
0.00%
0/101
|
|
General disorders
discomfort
|
0.00%
0/5
|
16.7%
1/6
|
0.94%
1/106
|
0.00%
0/101
|
|
General disorders
pyrexia
|
20.0%
1/5
|
0.00%
0/6
|
0.94%
1/106
|
3.0%
3/101
|
|
Injury, poisoning and procedural complications
anemia postoperative
|
0.00%
0/5
|
16.7%
1/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Injury, poisoning and procedural complications
incision site pain
|
20.0%
1/5
|
16.7%
1/6
|
10.4%
11/106
|
7.9%
8/101
|
|
Injury, poisoning and procedural complications
procedural hypotension
|
0.00%
0/5
|
16.7%
1/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Investigations
white blood cell count increased
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/106
|
0.00%
0/101
|
|
Metabolism and nutrition disorders
fluid overload
|
0.00%
0/5
|
16.7%
1/6
|
2.8%
3/106
|
0.00%
0/101
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/5
|
16.7%
1/6
|
3.8%
4/106
|
3.0%
3/101
|
|
Nervous system disorders
lethargy
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/106
|
0.99%
1/101
|
|
Nervous system disorders
metabolic encephalopathy
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/106
|
0.00%
0/101
|
|
Psychiatric disorders
agitation
|
0.00%
0/5
|
16.7%
1/6
|
2.8%
3/106
|
0.99%
1/101
|
|
Psychiatric disorders
confusional state
|
0.00%
0/5
|
16.7%
1/6
|
0.94%
1/106
|
0.99%
1/101
|
|
Psychiatric disorders
disorientation
|
0.00%
0/5
|
16.7%
1/6
|
1.9%
2/106
|
0.00%
0/101
|
|
Psychiatric disorders
restlessness
|
0.00%
0/5
|
16.7%
1/6
|
2.8%
3/106
|
0.00%
0/101
|
|
Renal and urinary disorders
azotaemia
|
0.00%
0/5
|
33.3%
2/6
|
0.00%
0/106
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
bronchial secretion retention
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/106
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
0.00%
0/5
|
16.7%
1/6
|
0.94%
1/106
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/106
|
0.00%
0/101
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/5
|
0.00%
0/6
|
6.6%
7/106
|
2.0%
2/101
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/5
|
0.00%
0/6
|
5.7%
6/106
|
0.99%
1/101
|
|
Psychiatric disorders
anxiety
|
0.00%
0/5
|
0.00%
0/6
|
6.6%
7/106
|
2.0%
2/101
|
|
Psychiatric disorders
insomnia
|
0.00%
0/5
|
0.00%
0/6
|
5.7%
6/106
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/5
|
0.00%
0/6
|
4.7%
5/106
|
8.9%
9/101
|
Additional Information
Meredith Todd - Sr. Director Program Management
The Medicines Company
Phone: +1.973.290.6088
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In general, PI communications regarding trial results are prohibited until after the communication and publication of the multi-center results by Sponsor, but no more than 12 months after conclusion of the trial at all sites. PI must submit results communications to sponsor for review at least 60 days prior to submission for publication and Sponsor may embargo such communications for a period that is less than or equal to 150 days solely to seek appropriate patent protection.
- Publication restrictions are in place
Restriction type: OTHER