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Trial Outcomes & Findings for Bupivacaine Effectiveness and Safety in SABER® Trial (NCT NCT01052012)

NCT ID: NCT01052012

Last Updated: 2021-06-01

Results Overview

Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

331 participants

Primary outcome timeframe

0 to 72 hours post-dose

Results posted on

2021-06-01

Participant Flow

The trial was conducted at 15 sites in the US, 3 sites in Australia, and 1 site in New Zealand. The study was initiated on 21 December 2009 and completed on 30 September 2011.

total of 393 patients were screened and 331 patients were randomized. There were 26 patients who were randomized but not treated. The reasons for not treating these patients included: conditions encountered during surgery necessitated procedures that did not meet protocol requirements, peri-operative epidural analgesia was administered, the test drug was not available, or the patient withdrew consent

Participant milestones

Participant milestones
Measure
Cohort 1-POSIMIR
Open Laparotomy
Cohort 1-Bupivacaine HCl
Open Laparotomy
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
Laparoscopic Assisted Colectomy
Overall Study
STARTED
32
23
30
20
140
86
Overall Study
COMPLETED
28
17
30
19
124
76
Overall Study
NOT COMPLETED
4
6
0
1
16
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1-POSIMIR
Open Laparotomy
Cohort 1-Bupivacaine HCl
Open Laparotomy
Cohort 2-POSIMIR
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
Laparoscopic Assisted Colectomy
Overall Study
Not treated
2
5
0
0
11
8
Overall Study
Adverse Event
1
0
0
1
0
0
Overall Study
Lost to Follow-up
0
0
0
0
1
0
Overall Study
Withdrawal by Subject
1
1
0
0
3
1
Overall Study
Physician Decision
0
0
0
0
0
1
Overall Study
Other
0
0
0
0
1
0

Baseline Characteristics

Bupivacaine Effectiveness and Safety in SABER® Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1-POSIMIR
n=30 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=18 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=129 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=78 Participants
Laparoscopic Assisted Colectomy
Total
n=305 Participants
Total of all reporting groups
Age, Continuous
56.8 years
n=5 Participants
53.8 years
n=7 Participants
44.2 years
n=5 Participants
39.5 years
n=4 Participants
60.2 years
n=21 Participants
58.2 years
n=10 Participants
56.1 years
n=115 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
9 Participants
n=7 Participants
20 Participants
n=5 Participants
14 Participants
n=4 Participants
70 Participants
n=21 Participants
34 Participants
n=10 Participants
165 Participants
n=115 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
9 Participants
n=7 Participants
10 Participants
n=5 Participants
6 Participants
n=4 Participants
59 Participants
n=21 Participants
44 Participants
n=10 Participants
140 Participants
n=115 Participants
BMI
30.5 kg/m^2
n=5 Participants
27.0 kg/m^2
n=7 Participants
30.8 kg/m^2
n=5 Participants
31.9 kg/m^2
n=4 Participants
29.4 kg/m^2
n=21 Participants
27.5 kg/m^2
n=10 Participants
29.2 kg/m^2
n=115 Participants

PRIMARY outcome

Timeframe: 0 to 72 hours post-dose

Population: ITT Population

Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Mean Pain Intensity on Movement
4.9 score on a scale
Interval 4.0 to 5.7
5.0 score on a scale
Interval 4.7 to 6.8
2.8 score on a scale
Interval 2.0 to 3.6
3.9 score on a scale
Interval 3.0 to 4.8
4.8 score on a scale
Interval 4.4 to 5.2
5.1 score on a scale
Interval 4.7 to 5.6

PRIMARY outcome

Timeframe: 0-72 hours post dose

Population: ITT Population

Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Supplemental Opioid Use
87.0 Milligram equivalents
Interval 30.0 to 157.0
63.0 Milligram equivalents
Interval 34.0 to 152.0
17.0 Milligram equivalents
Interval 8.0 to 26.0
22.5 Milligram equivalents
Interval 12.5 to 34.5
52.0 Milligram equivalents
Interval 24.0 to 86.6
62.0 Milligram equivalents
Interval 24.0 to 86.0

SECONDARY outcome

Timeframe: 0 to 48 hours post-dose

Population: ITT Population

Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Mean Pain Intensity on Movement
5.2 score on a scale
Interval 4.4 to 6.1
6.0 score on a scale
Interval 5.0 to 7.0
3.2 score on a scale
Interval 2.5 to 4.0
4.4 score on a scale
Interval 3.5 to 5.3
5.2 score on a scale
Interval 4.8 to 5.5
5.5 score on a scale
Interval 5.0 to 5.9

SECONDARY outcome

Timeframe: 0-48 hours post dose

Population: ITT Population

Total morphine-equivalent dose during 0-48 hours post dose.

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Total Morphine-equivalent Dose
69.5 mg IV Morphine equivalents
Interval 25.0 to 133.0
52.0 mg IV Morphine equivalents
Interval 29.0 to 122.0
15.0 mg IV Morphine equivalents
Interval 8.0 to 22.0
19.7 mg IV Morphine equivalents
Interval 12.5 to 32.5
41.5 mg IV Morphine equivalents
Interval 21.0 to 66.0
43.0 mg IV Morphine equivalents
Interval 21.2 to 68.0

SECONDARY outcome

Timeframe: 0 to 14 days post-dose (Visits 3 and 4)

Population: ITT Population

From Surgical Wound Healing and Local Tissue Condition Evaluation

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
Patients with Wound Infection at Visit 3 (Day 7) · yes
2 Participants
1 Participants
0 Participants
0 Participants
6 Participants
0 Participants
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
Patients with Wound Infection at Visit 3 (Day 7) · no
23 Participants
14 Participants
30 Participants
19 Participants
116 Participants
73 Participants
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
Patients with Wound Infection at Visit 4 (Day 14) · yes
1 Participants
2 Participants
0 Participants
1 Participants
4 Participants
0 Participants
Proportion (Percent) of Patients Who Have Evidence of a Wound Infection
Patients with Wound Infection at Visit 4 (Day 14) · no
23 Participants
14 Participants
30 Participants
18 Participants
119 Participants
77 Participants

SECONDARY outcome

Timeframe: 0 to 14 days post-dose (Time from extubation until first opioid use)

Population: ITT Population

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Time-to-first Use of Opioid Rescue Medication
0.6 Hours
Interval 0.2 to 39.2
0.5 Hours
Interval 0.0 to 6.7
0.6 Hours
Interval 0.1 to 11.3
0.5 Hours
Interval 0.1 to 23.9
0.6 Hours
Interval 0.0 to 22.6
0.5 Hours
Interval 0.0 to 15.6

SECONDARY outcome

Timeframe: 0 to 30 days post-dose

Population: ITT Population

AEs include: nausea, vomiting, constipation, dizziness, somnolence, urinary retention, respiratory depression

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Number (Incidence) of Participants With Opioid-related Side Effects
19 Participants
10 Participants
23 Participants
17 Participants
93 Participants
47 Participants

SECONDARY outcome

Timeframe: 0-72 hours post dose

Population: ITT Population

Mean pain intensity at rest AUC during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Pain Intensity at Rest AUC During 0-72 Hours Post Dose
3.4 score on a scale
Interval 2.5 to 4.3
4.2 score on a scale
Interval 3.2 to 5.2
1.7 score on a scale
Interval 1.1 to 2.3
2.5 score on a scale
Interval 1.8 to 3.3
3.1 score on a scale
Interval 2.7 to 3.5
3.5 score on a scale
Interval 3.0 to 3.9

SECONDARY outcome

Timeframe: 0-48 hours post dose

Population: ITT Population

Mean pain intensity at rest AUC during the period 0 to 48 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

Outcome measures

Outcome measures
Measure
Cohort 1-POSIMIR
n=26 Participants
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=17 Participants
Open Laparotomy
Cohort 2-POSIMIR
n=30 Participants
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 Participants
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=126 Participants
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=77 Participants
Laparoscopic Assisted Colectomy
Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose
3.6 score on a scale
Interval 2.7 to 4.4
4.5 score on a scale
Interval 3.4 to 5.5
2.0 score on a scale
Interval 1.4 to 2.6
2.9 score on a scale
Interval 2.1 to 3.6
3.4 score on a scale
Interval 3.0 to 3.8
3.8 score on a scale
Interval 3.4 to 4.3

Adverse Events

Cohort 1-POSIMIR

Serious events: 9 serious events
Other events: 30 other events
Deaths: 0 deaths

Cohort 1-Bupivacaine HCl

Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths

Cohort 2-POSIMIR

Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths

Cohort 2-Bupivacaine HCl

Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths

Cohort 3-POSIMIR

Serious events: 16 serious events
Other events: 126 other events
Deaths: 1 deaths

Cohort 3-Placebo

Serious events: 9 serious events
Other events: 75 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1-POSIMIR
n=30 participants at risk
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=18 participants at risk
Open Laparotomy
Cohort 2-POSIMIR
n=30 participants at risk
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 participants at risk
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=129 participants at risk
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=78 participants at risk
Laparoscopic Assisted Colectomy
Gastrointestinal disorders
Ileus
0.00%
0/30
5.6%
1/18
0.00%
0/30
0.00%
0/20
4.7%
6/129
1.3%
1/78
Gastrointestinal disorders
Colitis
0.00%
0/30
5.6%
1/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Gastrointestinal disorders
Abdominal pain
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Gastrointestinal disorders
Acute abdomen
3.3%
1/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Gastrointestinal disorders
Diarrhea
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Gastrointestinal disorders
Nausea
3.3%
1/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Gastrointestinal disorders
Vomiting
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Infections and infestations
Abdominal abscess
0.00%
0/30
5.6%
1/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
1.3%
1/78
Infections and infestations
Perirectal abscess
0.00%
0/30
5.6%
1/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Infections and infestations
Clostridium difficile colitis
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Infections and infestations
Peridiverticular abscess
3.3%
1/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Pneumonia
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Postoperative wound infection
3.3%
1/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Injury, poisoning and procedural complications
Wound dehiscence
6.7%
2/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Injury, poisoning and procedural complications
Postoperative ileus
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
1.3%
1/78
Injury, poisoning and procedural complications
Humerus fracture
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Apnoea
0.00%
0/30
5.6%
1/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Dyspnoea
3.3%
1/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
3.3%
1/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/30
5.6%
1/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Cardiac disorders
Acute myocardial infarction
3.3%
1/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Cardiac disorders
Atrial fibrillation
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Cardiac disorders
Atrial flutter
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Cardiac disorders
Supraventricular tachycardia
0.00%
0/30
5.6%
1/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
General disorders
Chest pain
6.7%
2/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Gastrointestinal disorders
Application site discolouration
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Blood and lymphatic system disorders
Anemia
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Vascular disorders
Deep vein thrombosis
3.3%
1/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Nervous system disorders
Presyncope
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78
Renal and urinary disorders
Urinary retention
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129
0.00%
0/78
Infections and infestations
Sepsis
0.00%
0/30
5.6%
1/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78

Other adverse events

Other adverse events
Measure
Cohort 1-POSIMIR
n=30 participants at risk
Open Laparotomy
Cohort 1-Bupivacaine HCl
n=18 participants at risk
Open Laparotomy
Cohort 2-POSIMIR
n=30 participants at risk
Laparoscopic Cholecystectomy
Cohort 2-Bupivacaine HCl
n=20 participants at risk
Laparoscopic Cholecystectomy
Cohort 3-POSIMIR
n=129 participants at risk
Laparoscopic Assisted Colectomy
Cohort 3-Placebo
n=78 participants at risk
Laparoscopic Assisted Colectomy
Gastrointestinal disorders
Nausea
53.3%
16/30 • Number of events 18
50.0%
9/18 • Number of events 11
56.7%
17/30 • Number of events 23
70.0%
14/20 • Number of events 20
59.7%
77/129 • Number of events 80
51.3%
40/78 • Number of events 42
Gastrointestinal disorders
Vomiting
30.0%
9/30 • Number of events 12
11.1%
2/18 • Number of events 2
30.0%
9/30 • Number of events 13
35.0%
7/20 • Number of events 10
17.8%
23/129 • Number of events 26
7.7%
6/78 • Number of events 6
Gastrointestinal disorders
Constipation
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
26.7%
8/30 • Number of events 8
40.0%
8/20 • Number of events 8
17.8%
23/129 • Number of events 23
10.3%
8/78 • Number of events 8
Gastrointestinal disorders
Abdominal distension
3.3%
1/30 • Number of events 1
11.1%
2/18 • Number of events 2
20.0%
6/30 • Number of events 6
15.0%
3/20 • Number of events 3
12.4%
16/129 • Number of events 19
15.4%
12/78 • Number of events 13
Gastrointestinal disorders
Diarrhoea
13.3%
4/30 • Number of events 5
5.6%
1/18 • Number of events 1
10.0%
3/30 • Number of events 3
10.0%
2/20 • Number of events 3
12.4%
16/129 • Number of events 16
12.8%
10/78 • Number of events 10
Gastrointestinal disorders
Flatulence
3.3%
1/30 • Number of events 1
11.1%
2/18 • Number of events 2
6.7%
2/30 • Number of events 2
5.0%
1/20 • Number of events 1
7.8%
10/129 • Number of events 10
10.3%
8/78 • Number of events 8
Gastrointestinal disorders
Dyspepsia
6.7%
2/30 • Number of events 2
11.1%
2/18 • Number of events 2
6.7%
2/30 • Number of events 4
0.00%
0/20
3.1%
4/129 • Number of events 4
5.1%
4/78 • Number of events 4
Gastrointestinal disorders
Ileus
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
7.0%
9/129 • Number of events 9
3.8%
3/78 • Number of events 3
Gastrointestinal disorders
Abdominal pain
6.7%
2/30 • Number of events 2
0.00%
0/18
6.7%
2/30 • Number of events 2
0.00%
0/20
4.7%
6/129 • Number of events 6
1.3%
1/78 • Number of events 1
Gastrointestinal disorders
Gastrooesophageal reflux disease
6.7%
2/30 • Number of events 2
0.00%
0/18
3.3%
1/30 • Number of events 1
10.0%
2/20 • Number of events 2
3.1%
4/129 • Number of events 4
1.3%
1/78 • Number of events 1
Gastrointestinal disorders
Haematochezia
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
2.3%
3/129 • Number of events 3
1.3%
1/78 • Number of events 1
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
1.6%
2/129 • Number of events 2
1.3%
1/78 • Number of events 1
Gastrointestinal disorders
Abdominal rigidity
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
0.00%
0/78
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/30
0.00%
0/18
6.7%
2/30 • Number of events 3
0.00%
0/20
0.00%
0/129
0.00%
0/78
Gastrointestinal disorders
Colitis
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
0.00%
0/78
Gastrointestinal disorders
Ascites
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Gastrointestinal disorders
Oesophageal Ulcer
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
General disorders
Application site discolouration
46.7%
14/30 • Number of events 17
33.3%
6/18 • Number of events 7
50.0%
15/30 • Number of events 18
20.0%
4/20 • Number of events 5
62.0%
80/129 • Number of events 116
59.0%
46/78 • Number of events 66
General disorders
Pyrexia
23.3%
7/30 • Number of events 7
16.7%
3/18 • Number of events 3
6.7%
2/30 • Number of events 2
5.0%
1/20 • Number of events 1
10.9%
14/129 • Number of events 14
14.1%
11/78 • Number of events 11
General disorders
Fatigue
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
16.7%
5/30 • Number of events 5
15.0%
3/20 • Number of events 3
3.1%
4/129 • Number of events 4
3.8%
3/78 • Number of events 3
General disorders
Chest pain
10.0%
3/30 • Number of events 3
0.00%
0/18
10.0%
3/30 • Number of events 6
5.0%
1/20 • Number of events 6
2.3%
3/129 • Number of events 3
1.3%
1/78 • Number of events 1
General disorders
Oedema peripheral
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
3.8%
3/78 • Number of events 3
General disorders
Chills
3.3%
1/30 • Number of events 1
0.00%
0/18
0.00%
0/30
10.0%
2/20 • Number of events 2
0.00%
0/129
1.3%
1/78 • Number of events 1
General disorders
Drug intolerance
0.00%
0/30
0.00%
0/18
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
General disorders
Infusion site pain
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
0.00%
0/78
General disorders
Induration
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
General disorders
Infusion site pruritus
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
General disorders
Non-cardiac chest pain
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
Nervous system disorders
Headache
10.0%
3/30 • Number of events 3
5.6%
1/18 • Number of events 1
36.7%
11/30 • Number of events 15
5.0%
1/20 • Number of events 1
7.0%
9/129 • Number of events 9
15.4%
12/78 • Number of events 12
Nervous system disorders
Dizziness
10.0%
3/30 • Number of events 3
5.6%
1/18 • Number of events 1
23.3%
7/30 • Number of events 7
20.0%
4/20 • Number of events 5
10.1%
13/129 • Number of events 13
7.7%
6/78 • Number of events 6
Nervous system disorders
Dysgeusia
6.7%
2/30 • Number of events 2
5.6%
1/18 • Number of events 1
6.7%
2/30 • Number of events 3
0.00%
0/20
2.3%
3/129 • Number of events 3
2.6%
2/78 • Number of events 2
Nervous system disorders
Somnolence
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
10.0%
2/20 • Number of events 2
2.3%
3/129 • Number of events 3
3.8%
3/78 • Number of events 3
Nervous system disorders
Paraesthesia
0.00%
0/30
0.00%
0/18
6.7%
2/30 • Number of events 3
15.0%
3/20 • Number of events 3
0.00%
0/129
2.6%
2/78 • Number of events 2
Nervous system disorders
Lethargy
0.00%
0/30
0.00%
0/18
6.7%
2/30 • Number of events 2
0.00%
0/20
0.78%
1/129 • Number of events 1
0.00%
0/78
Nervous system disorders
Hypogeusia
0.00%
0/30
0.00%
0/18
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
Injury, poisoning and procedural complications
Incision site haemorrhage
13.3%
4/30 • Number of events 4
0.00%
0/18
0.00%
0/30
0.00%
0/20
14.0%
18/129 • Number of events 18
3.8%
3/78 • Number of events 3
Injury, poisoning and procedural complications
Wound secretion
6.7%
2/30 • Number of events 3
5.6%
1/18 • Number of events 1
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
10.9%
14/129 • Number of events 15
7.7%
6/78 • Number of events 7
Injury, poisoning and procedural complications
Wound dehiscence
10.0%
3/30 • Number of events 3
0.00%
0/18
3.3%
1/30 • Number of events 1
0.00%
0/20
5.4%
7/129 • Number of events 7
5.1%
4/78 • Number of events 4
Injury, poisoning and procedural complications
Procedural hypertension
0.00%
0/30
0.00%
0/18
13.3%
4/30 • Number of events 4
15.0%
3/20 • Number of events 4
0.00%
0/129
0.00%
0/78
Injury, poisoning and procedural complications
Postoperative ileus
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
1.6%
2/129 • Number of events 2
1.3%
1/78 • Number of events 1
Injury, poisoning and procedural complications
Procedural hypotension
0.00%
0/30
0.00%
0/18
0.00%
0/30
15.0%
3/20 • Number of events 3
0.00%
0/129
0.00%
0/78
Injury, poisoning and procedural complications
Procedural nausea
0.00%
0/30
0.00%
0/18
6.7%
2/30 • Number of events 2
0.00%
0/20
0.00%
0/129
1.3%
1/78 • Number of events 1
Injury, poisoning and procedural complications
Incision site hypoaesthesia
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
Injury, poisoning and procedural complications
Incision site pruritus
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
Infections and infestations
Postoperative wound infection
13.3%
4/30 • Number of events 6
11.1%
2/18 • Number of events 2
0.00%
0/30
5.0%
1/20 • Number of events 1
7.0%
9/129 • Number of events 10
2.6%
2/78 • Number of events 2
Infections and infestations
Urinary tract infection
3.3%
1/30 • Number of events 1
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
5.4%
7/129 • Number of events 7
10.3%
8/78 • Number of events 8
Infections and infestations
Pneumonia
10.0%
3/30 • Number of events 3
5.6%
1/18 • Number of events 1
0.00%
0/30
5.0%
1/20 • Number of events 1
0.78%
1/129 • Number of events 1
0.00%
0/78
Infections and infestations
Upper respiratory tract infection
0.00%
0/30
0.00%
0/18
3.3%
1/30 • Number of events 1
15.0%
3/20 • Number of events 3
0.78%
1/129 • Number of events 1
0.00%
0/78
Injury, poisoning and procedural complications
Postoperative fever
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
Infections and infestations
Abdominal abscess
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
1.3%
1/78 • Number of events 1
Infections and infestations
Lower respiratory tract infection
6.7%
2/30 • Number of events 2
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Oral candidiasis
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Perirectal abscess
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
1.3%
1/78 • Number of events 1
Infections and infestations
Candidiasis
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Lobar pneumonia
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Rash pustular
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Sepsis
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Skin candida
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Investigations
Blood phosphorus decreased
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
3.1%
4/129 • Number of events 4
2.6%
2/78 • Number of events 2
Investigations
Haemoglobin decreased
6.7%
2/30 • Number of events 2
0.00%
0/18
0.00%
0/30
0.00%
0/20
2.3%
3/129 • Number of events 3
2.6%
2/78 • Number of events 2
Investigations
Blood glucose increased
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
2.3%
3/129 • Number of events 3
0.00%
0/78
Investigations
Blood magnesium decreased
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
1.3%
1/78 • Number of events 1
Investigations
Oxygen saturation decreased
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
1.3%
1/78 • Number of events 1
Investigations
Liver function test abnormal
6.7%
2/30 • Number of events 2
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
0.00%
0/78
Investigations
Breath sounds abnormal
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Metabolism and nutrition disorders
Hypokalaemia
26.7%
8/30 • Number of events 10
11.1%
2/18 • Number of events 2
0.00%
0/30
0.00%
0/20
10.9%
14/129 • Number of events 14
12.8%
10/78 • Number of events 11
Metabolism and nutrition disorders
Decreased appetite
3.3%
1/30 • Number of events 1
0.00%
0/18
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
1.6%
2/129 • Number of events 2
7.7%
6/78 • Number of events 6
Metabolism and nutrition disorders
Hyperglycaemia
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
1.6%
2/129 • Number of events 2
1.3%
1/78 • Number of events 1
Metabolism and nutrition disorders
Fluid overload
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Musculoskeletal and connective tissue disorders
Back Pain
6.7%
2/30 • Number of events 2
5.6%
1/18 • Number of events 1
3.3%
1/30 • Number of events 1
25.0%
5/20 • Number of events 8
3.9%
5/129 • Number of events 5
11.5%
9/78 • Number of events 9
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
3.3%
1/30 • Number of events 1
0.00%
0/18
26.7%
8/30 • Number of events 18
35.0%
7/20 • Number of events 9
4.7%
6/129 • Number of events 6
0.00%
0/78
Musculoskeletal and connective tissue disorders
Pain in extremity
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
1.6%
2/129 • Number of events 2
1.3%
1/78 • Number of events 1
Musculoskeletal and connective tissue disorders
Muscle spasms
3.3%
1/30 • Number of events 1
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
5.1%
4/78 • Number of events 5
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/30
0.00%
0/18
6.7%
2/30 • Number of events 2
5.0%
1/20 • Number of events 1
1.6%
2/129 • Number of events 2
0.00%
0/78
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.78%
1/129 • Number of events 1
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Dyspnoea
6.7%
2/30 • Number of events 2
16.7%
3/18 • Number of events 3
6.7%
2/30 • Number of events 3
5.0%
1/20 • Number of events 1
0.78%
1/129 • Number of events 1
1.3%
1/78 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Cough
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
3.1%
4/129 • Number of events 4
1.3%
1/78 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
10.0%
3/30 • Number of events 3
0.00%
0/18
0.00%
0/30
0.00%
0/20
3.1%
4/129 • Number of events 4
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Productive cough
6.7%
2/30 • Number of events 2
11.1%
2/18 • Number of events 2
0.00%
0/30
0.00%
0/20
1.6%
2/129 • Number of events 2
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Atelectasis
6.7%
2/30 • Number of events 2
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
2.6%
2/78 • Number of events 2
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
2.3%
3/129 • Number of events 3
1.3%
1/78 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Apnoea
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 2
0.00%
0/129
1.3%
1/78 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Tachypnoea
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.78%
1/129 • Number of events 1
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
0.00%
0/129
0.00%
0/78
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Skin and subcutaneous tissue disorders
Pruritus
6.7%
2/30 • Number of events 2
11.1%
2/18 • Number of events 2
3.3%
1/30 • Number of events 1
5.0%
1/20 • Number of events 1
6.2%
8/129 • Number of events 8
6.4%
5/78 • Number of events 5
Skin and subcutaneous tissue disorders
Hyperhidrosis
3.3%
1/30 • Number of events 1
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
2.3%
3/129 • Number of events 3
3.8%
3/78 • Number of events 3
Skin and subcutaneous tissue disorders
Rash
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
5.0%
1/20 • Number of events 1
3.1%
4/129 • Number of events 4
1.3%
1/78 • Number of events 1
Skin and subcutaneous tissue disorders
Pruritus generalised
0.00%
0/30
5.6%
1/18 • Number of events 1
3.3%
1/30 • Number of events 1
0.00%
0/20
2.3%
3/129 • Number of events 3
1.3%
1/78 • Number of events 1
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 1
1.6%
2/129 • Number of events 2
2.6%
2/78 • Number of events 2
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Cardiac disorders
Tachycardia
10.0%
3/30 • Number of events 3
22.2%
4/18 • Number of events 4
3.3%
1/30 • Number of events 1
10.0%
2/20 • Number of events 2
7.8%
10/129 • Number of events 11
3.8%
3/78 • Number of events 3
Cardiac disorders
Sinus tachycardia
0.00%
0/30
11.1%
2/18 • Number of events 2
0.00%
0/30
0.00%
0/20
2.3%
3/129 • Number of events 3
1.3%
1/78 • Number of events 1
Cardiac disorders
Supraventricular tachycardia
0.00%
0/30
11.1%
2/18 • Number of events 2
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Psychiatric disorders
Insomnia
6.7%
2/30 • Number of events 2
0.00%
0/18
6.7%
2/30 • Number of events 2
15.0%
3/20 • Number of events 3
6.2%
8/129 • Number of events 8
9.0%
7/78 • Number of events 7
Psychiatric disorders
Confusional state
6.7%
2/30 • Number of events 2
0.00%
0/18
0.00%
0/30
0.00%
0/20
1.6%
2/129 • Number of events 3
1.3%
1/78 • Number of events 1
Vascular disorders
Hypertension
6.7%
2/30 • Number of events 2
0.00%
0/18
0.00%
0/30
0.00%
0/20
7.0%
9/129 • Number of events 9
1.3%
1/78 • Number of events 1
Vascular disorders
Deep vein thrombosis
6.7%
2/30 • Number of events 2
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.78%
1/129 • Number of events 1
2.6%
2/78 • Number of events 2
Blood and lymphatic system disorders
Anaemia
13.3%
4/30 • Number of events 4
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
10.1%
13/129 • Number of events 13
9.0%
7/78 • Number of events 7
Blood and lymphatic system disorders
Leukocytosis
3.3%
1/30 • Number of events 1
11.1%
2/18 • Number of events 2
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Blood and lymphatic system disorders
Haemorrhagic anaemia
3.3%
1/30 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Blood and lymphatic system disorders
Thrombocytosis
6.7%
2/30 • Number of events 2
0.00%
0/18
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/30
5.6%
1/18 • Number of events 1
0.00%
0/30
0.00%
0/20
0.00%
0/129
0.00%
0/78
Renal and urinary disorders
Urinary retention
10.0%
3/30 • Number of events 3
5.6%
1/18 • Number of events 1
3.3%
1/30 • Number of events 1
0.00%
0/20
3.1%
4/129 • Number of events 4
5.1%
4/78 • Number of events 4
Eye disorders
Vision blurred
0.00%
0/30
0.00%
0/18
0.00%
0/30
5.0%
1/20 • Number of events 2
1.6%
2/129 • Number of events 2
0.00%
0/78
Ear and labyrinth disorders
Tinnitus
0.00%
0/30
0.00%
0/18
0.00%
0/30
15.0%
3/20 • Number of events 3
0.00%
0/129
1.3%
1/78 • Number of events 1
Vascular disorders
Hypotension
3.3%
1/30 • Number of events 1
0.00%
0/18
0.00%
0/30
0.00%
0/20
3.9%
5/129 • Number of events 5
7.7%
6/78 • Number of events 6
Investigations
Body temperature increased
3.3%
1/30 • Number of events 1
0.00%
0/18
3.3%
1/30 • Number of events 1
0.00%
0/20
5.4%
7/129 • Number of events 7
2.6%
2/78 • Number of events 2
Investigations
Blood urine present
0.00%
0/30
0.00%
0/18
0.00%
0/30
0.00%
0/20
2.3%
3/129 • Number of events 3
5.1%
4/78 • Number of events 4

Additional Information

Deborah Scott

Durect Corporation

Phone: 408-777-1417

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place