Trial Outcomes & Findings for A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume (NCT NCT00816023)
NCT ID: NCT00816023
Last Updated: 2015-08-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
276 participants
Primary outcome timeframe
Start of surgery up to 12 hours after the end of surgery
Results posted on
2015-08-11
Participant Flow
Participant milestones
| Measure |
Ecallantide Low Dose
target steady state concentration of 0.15 mg/L
|
Ecallantide Medium Dose
target steady state concentration of 0.75 mg/L
|
Ecallantide High Dose
target steady state concentration of 2.25 mg/L
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
62
|
69
|
74
|
|
Overall Study
Completed Therapy
|
65
|
59
|
61
|
63
|
|
Overall Study
COMPLETED
|
62
|
56
|
60
|
62
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
9
|
12
|
Reasons for withdrawal
| Measure |
Ecallantide Low Dose
target steady state concentration of 0.15 mg/L
|
Ecallantide Medium Dose
target steady state concentration of 0.75 mg/L
|
Ecallantide High Dose
target steady state concentration of 2.25 mg/L
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
assessments complete prior to window
|
1
|
1
|
2
|
1
|
|
Overall Study
Randomized Not Treated
|
6
|
4
|
6
|
11
|
Baseline Characteristics
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
Baseline characteristics by cohort
| Measure |
Ecallantide Low Dose
n=71 Participants
target steady state concentration of 0.15 mg/L
|
Ecallantide Medium Dose
n=62 Participants
target steady state concentration of 0.75 mg/L
|
Ecallantide High Dose
n=69 Participants
target steady state concentration of 2.25 mg/L
|
Placebo
n=74 Participants
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 9.40 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 10.90 • n=4 Participants
|
63.4 years
STANDARD_DEVIATION 10.15 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
222 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
252 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Start of surgery up to 12 hours after the end of surgeryPopulation: The Modified Intent to Treat population was the basis of this analysis, defined as all randomized subjects who received any amount of study drug and analyzed according to the planned treatment assignment.
Outcome measures
| Measure |
Ecallantide Low Dose
n=65 Participants
target steady state concentration of 0.15 mg/L
|
Ecallantide Medium Dose
n=58 Participants
target steady state concentration of 0.75 mg/L
|
Ecallantide High Dose
n=63 Participants
target steady state concentration of 2.25 mg/L
|
Placebo
n=63 Participants
|
|---|---|---|---|---|
|
Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery
|
401.9 mL
Standard Deviation 624.87
|
383.1 mL
Standard Deviation 620.62
|
410.3 mL
Standard Deviation 639.47
|
377.6 mL
Standard Deviation 608.54
|
SECONDARY outcome
Timeframe: Over the duration of the study.Population: Analysis conducted on Safety population, defined as all subjects randomized and received any study drug. Treatment groups are based on actual treatment received.
Outcome measures
| Measure |
Ecallantide Low Dose
n=65 Participants
target steady state concentration of 0.15 mg/L
|
Ecallantide Medium Dose
n=59 Participants
target steady state concentration of 0.75 mg/L
|
Ecallantide High Dose
n=62 Participants
target steady state concentration of 2.25 mg/L
|
Placebo
n=63 Participants
|
|---|---|---|---|---|
|
Treatment-emergent Adverse Events
At least 1 Treatment-related SAE
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Treatment-emergent Adverse Events
At least 1 TEAE
|
65 participants
|
59 participants
|
62 participants
|
63 participants
|
|
Treatment-emergent Adverse Events
At least 1 Treatment-related AE
|
7 participants
|
9 participants
|
4 participants
|
7 participants
|
|
Treatment-emergent Adverse Events
At least 1 AE of Severe Intensity
|
11 participants
|
13 participants
|
15 participants
|
16 participants
|
|
Treatment-emergent Adverse Events
At least 1 Treatment-emergent SAE
|
15 participants
|
19 participants
|
19 participants
|
15 participants
|
|
Treatment-emergent Adverse Events
TEAE Resulting on Discontinuation of Study Drug
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Treatment-emergent Adverse Events
TEAE Resulting in Death
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Treatment-emergent Adverse Events
Treatment-related TEAE Resulting in Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
ECALLANTIDE HIGH DOSE
Serious events: 19 serious events
Other events: 62 other events
Deaths: 0 deaths
ECALLANTIDE MEDIUM DOSE
Serious events: 19 serious events
Other events: 59 other events
Deaths: 0 deaths
ECALLANTIDE LOW DOSE
Serious events: 15 serious events
Other events: 65 other events
Deaths: 0 deaths
PLACEBO
Serious events: 15 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ECALLANTIDE HIGH DOSE
n=62 participants at risk
Target steady state concentration of 2.25 mg/L
|
ECALLANTIDE MEDIUM DOSE
n=59 participants at risk
Target steady state concentration of 0.75 mg/L
|
ECALLANTIDE LOW DOSE
n=65 participants at risk
Target steady state concentration of 0.15 mg/L
|
PLACEBO
n=63 participants at risk
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
3/62 • Number of events 3
|
5.1%
3/59 • Number of events 3
|
3.1%
2/65 • Number of events 2
|
6.3%
4/63 • Number of events 4
|
|
Cardiac disorders
Atrial flutter
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
Cardiac disorders
Cardiac failure
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
3.2%
2/63 • Number of events 2
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
Cardiac disorders
Cardiogenic shock
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Cardiac disorders
Intracardiac thrombus
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/62 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/62
|
0.00%
0/59
|
0.00%
0/65
|
1.6%
1/63 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
1.6%
1/63 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
General disorders
Hyperthermia
|
0.00%
0/62
|
0.00%
0/59
|
0.00%
0/65
|
1.6%
1/63 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
General disorders
Secretion discharge
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Infections and infestations
Bronchitis
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Infections and infestations
Cellulitis
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
|
Infections and infestations
Incision site cellulitis
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Infections and infestations
Pneumonia
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Infections and infestations
Postoperative wound infection
|
3.2%
2/62 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
3.2%
2/63 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Infections and infestations
Staphylococcal sepsis
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Femoral nerve injury
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
9.7%
6/62 • Number of events 6
|
6.8%
4/59 • Number of events 4
|
9.2%
6/65 • Number of events 6
|
4.8%
3/63 • Number of events 3
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/62
|
3.4%
2/59 • Number of events 2
|
0.00%
0/65
|
0.00%
0/63
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Nervous system disorders
Encephalopathy
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
1.6%
1/63 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/62
|
0.00%
0/59
|
0.00%
0/65
|
1.6%
1/63 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Renal and urinary disorders
Renal failure acute
|
3.2%
2/62 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
1/62 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
3.2%
2/63 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/62 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
0.00%
0/65
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/62 • Number of events 1
|
5.1%
3/59 • Number of events 4
|
1.5%
1/65 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/62
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
0.00%
0/63
|
|
Vascular disorders
Hypotension
|
0.00%
0/62
|
5.1%
3/59 • Number of events 3
|
0.00%
0/65
|
1.6%
1/63 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
Other adverse events
| Measure |
ECALLANTIDE HIGH DOSE
n=62 participants at risk
Target steady state concentration of 2.25 mg/L
|
ECALLANTIDE MEDIUM DOSE
n=59 participants at risk
Target steady state concentration of 0.75 mg/L
|
ECALLANTIDE LOW DOSE
n=65 participants at risk
Target steady state concentration of 0.15 mg/L
|
PLACEBO
n=63 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.9%
21/62 • Number of events 21
|
50.8%
30/59 • Number of events 31
|
38.5%
25/65 • Number of events 28
|
34.9%
22/63 • Number of events 23
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.9%
8/62 • Number of events 8
|
8.5%
5/59 • Number of events 5
|
6.2%
4/65 • Number of events 5
|
6.3%
4/63 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.3%
7/62 • Number of events 7
|
10.2%
6/59 • Number of events 6
|
9.2%
6/65 • Number of events 6
|
7.9%
5/63 • Number of events 5
|
|
Cardiac disorders
Atrial fibrillation
|
29.0%
18/62 • Number of events 20
|
39.0%
23/59 • Number of events 23
|
26.2%
17/65 • Number of events 17
|
19.0%
12/63 • Number of events 12
|
|
Cardiac disorders
Atrial flutter
|
1.6%
1/62 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
0.00%
0/65
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
4.8%
3/62 • Number of events 3
|
5.1%
3/59 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
1.6%
1/62 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
3.1%
2/65 • Number of events 2
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
11.3%
7/62 • Number of events 7
|
13.6%
8/59 • Number of events 8
|
13.8%
9/65 • Number of events 9
|
17.5%
11/63 • Number of events 11
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/62
|
5.1%
3/59 • Number of events 3
|
0.00%
0/65
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
6.5%
4/62 • Number of events 5
|
11.9%
7/59 • Number of events 7
|
4.6%
3/65 • Number of events 3
|
7.9%
5/63 • Number of events 5
|
|
Cardiac disorders
Ventricular extrasystoles
|
11.3%
7/62 • Number of events 8
|
8.5%
5/59 • Number of events 6
|
3.1%
2/65 • Number of events 2
|
6.3%
4/63 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
38.7%
24/62 • Number of events 24
|
40.7%
24/59 • Number of events 24
|
30.8%
20/65 • Number of events 20
|
27.0%
17/63 • Number of events 17
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/62
|
6.8%
4/59 • Number of events 4
|
4.6%
3/65 • Number of events 3
|
1.6%
1/63 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
3/62 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
3.1%
2/65 • Number of events 2
|
1.6%
1/63 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
31/62 • Number of events 31
|
37.3%
22/59 • Number of events 23
|
46.2%
30/65 • Number of events 30
|
46.0%
29/63 • Number of events 29
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
8/62 • Number of events 9
|
8.5%
5/59 • Number of events 5
|
7.7%
5/65 • Number of events 5
|
3.2%
2/63 • Number of events 2
|
|
General disorders
Asthenia
|
1.6%
1/62 • Number of events 1
|
8.5%
5/59 • Number of events 5
|
4.6%
3/65 • Number of events 3
|
1.6%
1/63 • Number of events 1
|
|
General disorders
Chills
|
9.7%
6/62 • Number of events 6
|
6.8%
4/59 • Number of events 4
|
6.2%
4/65 • Number of events 4
|
4.8%
3/63 • Number of events 3
|
|
General disorders
Generalised oedema
|
35.5%
22/62 • Number of events 22
|
37.3%
22/59 • Number of events 23
|
26.2%
17/65 • Number of events 17
|
25.4%
16/63 • Number of events 17
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/62 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
3.1%
2/65 • Number of events 2
|
1.6%
1/63 • Number of events 1
|
|
General disorders
Oedema
|
4.8%
3/62 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
3.1%
2/65 • Number of events 2
|
4.8%
3/63 • Number of events 3
|
|
General disorders
Oedema peripheral
|
11.3%
7/62 • Number of events 7
|
10.2%
6/59 • Number of events 6
|
12.3%
8/65 • Number of events 8
|
12.7%
8/63 • Number of events 8
|
|
General disorders
Pain
|
8.1%
5/62 • Number of events 6
|
5.1%
3/59 • Number of events 3
|
7.7%
5/65 • Number of events 7
|
1.6%
1/63 • Number of events 1
|
|
General disorders
Pyrexia
|
11.3%
7/62 • Number of events 7
|
23.7%
14/59 • Number of events 14
|
13.8%
9/65 • Number of events 9
|
12.7%
8/63 • Number of events 8
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
12.9%
8/62 • Number of events 8
|
8.5%
5/59 • Number of events 5
|
7.7%
5/65 • Number of events 5
|
6.3%
4/63 • Number of events 4
|
|
Injury, poisoning and procedural complications
Incision site pain
|
29.0%
18/62 • Number of events 20
|
30.5%
18/59 • Number of events 19
|
21.5%
14/65 • Number of events 17
|
30.2%
19/63 • Number of events 19
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/62
|
5.1%
3/59 • Number of events 3
|
3.1%
2/65 • Number of events 2
|
6.3%
4/63 • Number of events 4
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
8.1%
5/62 • Number of events 6
|
3.4%
2/59 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
6.3%
4/63 • Number of events 4
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.6%
1/62 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
11.1%
7/63 • Number of events 7
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
6.5%
4/62 • Number of events 4
|
6.8%
4/59 • Number of events 4
|
1.5%
1/65 • Number of events 1
|
3.2%
2/63 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural pain
|
67.7%
42/62 • Number of events 43
|
61.0%
36/59 • Number of events 36
|
67.7%
44/65 • Number of events 44
|
58.7%
37/63 • Number of events 37
|
|
Investigations
Blood calcium decreased
|
1.6%
1/62 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
3.2%
2/63 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
0.00%
0/62
|
0.00%
0/59
|
6.2%
4/65 • Number of events 4
|
3.2%
2/63 • Number of events 2
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/62
|
5.1%
3/59 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
Investigations
Body temperature increased
|
4.8%
3/62 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
10.8%
7/65 • Number of events 7
|
3.2%
2/63 • Number of events 2
|
|
Investigations
Breath sounds abnormal
|
3.2%
2/62 • Number of events 2
|
5.1%
3/59 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
4.8%
3/63 • Number of events 3
|
|
Investigations
Urine output decreased
|
6.5%
4/62 • Number of events 4
|
13.6%
8/59 • Number of events 8
|
7.7%
5/65 • Number of events 5
|
7.9%
5/63 • Number of events 5
|
|
Investigations
White blood cell count increased
|
8.1%
5/62 • Number of events 5
|
10.2%
6/59 • Number of events 6
|
4.6%
3/65 • Number of events 3
|
9.5%
6/63 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
6.5%
4/62 • Number of events 4
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
0.00%
0/63
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.8%
3/62 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
7.7%
5/65 • Number of events 5
|
1.6%
1/63 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
43.5%
27/62 • Number of events 28
|
40.7%
24/59 • Number of events 24
|
35.4%
23/65 • Number of events 23
|
44.4%
28/63 • Number of events 28
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.5%
4/62 • Number of events 4
|
5.1%
3/59 • Number of events 4
|
6.2%
4/65 • Number of events 4
|
1.6%
1/63 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
6.5%
4/62 • Number of events 4
|
5.1%
3/59 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
4.8%
3/63 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.5%
9/62 • Number of events 9
|
10.2%
6/59 • Number of events 6
|
6.2%
4/65 • Number of events 4
|
7.9%
5/63 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.7%
6/62 • Number of events 6
|
8.5%
5/59 • Number of events 5
|
3.1%
2/65 • Number of events 2
|
6.3%
4/63 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.7%
6/62 • Number of events 6
|
15.3%
9/59 • Number of events 9
|
10.8%
7/65 • Number of events 7
|
19.0%
12/63 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/62
|
5.1%
3/59 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
4.8%
3/63 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.5%
4/62 • Number of events 4
|
1.7%
1/59 • Number of events 1
|
0.00%
0/65
|
4.8%
3/63 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/62 • Number of events 1
|
8.5%
5/59 • Number of events 6
|
4.6%
3/65 • Number of events 3
|
4.8%
3/63 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
1.6%
1/62 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
4.6%
3/65 • Number of events 3
|
3.2%
2/63 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/62
|
5.1%
3/59 • Number of events 3
|
7.7%
5/65 • Number of events 5
|
1.6%
1/63 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
8.1%
5/62 • Number of events 6
|
5.1%
3/59 • Number of events 3
|
7.7%
5/65 • Number of events 5
|
4.8%
3/63 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
3.2%
2/62 • Number of events 2
|
5.1%
3/59 • Number of events 4
|
13.8%
9/65 • Number of events 9
|
11.1%
7/63 • Number of events 7
|
|
Psychiatric disorders
Confusional state
|
9.7%
6/62 • Number of events 6
|
5.1%
3/59 • Number of events 3
|
12.3%
8/65 • Number of events 8
|
6.3%
4/63 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
8.1%
5/62 • Number of events 5
|
15.3%
9/59 • Number of events 9
|
18.5%
12/65 • Number of events 12
|
11.1%
7/63 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
48.4%
30/62 • Number of events 32
|
44.1%
26/59 • Number of events 27
|
35.4%
23/65 • Number of events 24
|
44.4%
28/63 • Number of events 28
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/62
|
5.1%
3/59 • Number of events 3
|
0.00%
0/65
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
2/62 • Number of events 2
|
6.8%
4/59 • Number of events 4
|
10.8%
7/65 • Number of events 7
|
4.8%
3/63 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
38.7%
24/62 • Number of events 26
|
30.5%
18/59 • Number of events 21
|
20.0%
13/65 • Number of events 14
|
27.0%
17/63 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.5%
4/62 • Number of events 5
|
5.1%
3/59 • Number of events 3
|
4.6%
3/65 • Number of events 3
|
11.1%
7/63 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.8%
3/62 • Number of events 3
|
3.4%
2/59 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
7.9%
5/63 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/62
|
0.00%
0/59
|
1.5%
1/65 • Number of events 1
|
6.3%
4/63 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
6.5%
4/62 • Number of events 4
|
18.6%
11/59 • Number of events 12
|
12.3%
8/65 • Number of events 8
|
7.9%
5/63 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
8.1%
5/62 • Number of events 5
|
11.9%
7/59 • Number of events 7
|
7.7%
5/65 • Number of events 5
|
4.8%
3/63 • Number of events 3
|
|
Vascular disorders
Haematoma
|
1.6%
1/62 • Number of events 1
|
0.00%
0/59
|
6.2%
4/65 • Number of events 5
|
1.6%
1/63 • Number of events 3
|
|
Vascular disorders
Hypertension
|
12.9%
8/62 • Number of events 8
|
13.6%
8/59 • Number of events 8
|
15.4%
10/65 • Number of events 10
|
11.1%
7/63 • Number of events 7
|
|
Vascular disorders
Hypotension
|
38.7%
24/62 • Number of events 25
|
42.4%
25/59 • Number of events 26
|
43.1%
28/65 • Number of events 31
|
27.0%
17/63 • Number of events 17
|
Additional Information
Alistair Wheeler, MD, MFPM, Senior Director Clinical Research
Cubist Pharmaceuticals, Inc.
Phone: 781-860-8660
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication is initiated by Cubist. If the First Publication is not published within 1 year of Study conclusion or termination, Investigator shall have the right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER