Trial Outcomes & Findings for A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia (NCT NCT00515034)
NCT ID: NCT00515034
Last Updated: 2019-03-19
Results Overview
Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
VAP Treated With Doripenem
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
|
VAP Treated With Imipenem/Cilastatin
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
|
cIAI Treated With Doripenem
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
cIAI Treated With Imipenem/Cilastatin
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
15
|
62
|
20
|
|
Overall Study
TREATED
|
48
|
15
|
61
|
19
|
|
Overall Study
COMPLETED
|
41
|
13
|
54
|
15
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
8
|
5
|
Reasons for withdrawal
| Measure |
VAP Treated With Doripenem
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
|
VAP Treated With Imipenem/Cilastatin
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
|
cIAI Treated With Doripenem
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
cIAI Treated With Imipenem/Cilastatin
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
|
Overall Study
Death
|
4
|
2
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
2
|
1
|
Baseline Characteristics
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
Baseline characteristics by cohort
| Measure |
VAP Treated With Doripenem
n=49 Participants
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
|
VAP Treated With Imipenem/Cilastatin
n=15 Participants
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
|
cIAI Treated With Doripenem
n=62 Participants
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
cIAI Treated With Imipenem/Cilastatin
n=20 Participants
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
35 participants
n=5 Participants
|
11 participants
n=7 Participants
|
48 participants
n=5 Participants
|
16 participants
n=4 Participants
|
110 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
14 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
4 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Region of Enrollment
North America
|
14 participants
n=5 Participants
|
3 participants
n=7 Participants
|
24 participants
n=5 Participants
|
7 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
19 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
4 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
Region of Enrollment
South America
|
16 participants
n=5 Participants
|
5 participants
n=7 Participants
|
23 participants
n=5 Participants
|
9 participants
n=4 Participants
|
53 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapyPopulation: population is the as-treated analysis set - that is subjects who were administered therapy
Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.
Outcome measures
| Measure |
VAP Treated With Doripenem
n=48 Participants
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
|
VAP Treated With Imipenem/Cilastatin
n=15 Participants
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
|
cIAI Treated With Doripenem
n=61 Participants
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
cIAI Treated With Imipenem/Cilastatin
n=19 Participants
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
|---|---|---|---|---|
|
Patients With Incidence of Treatment-emergent Adverse Events (TEAEs).
|
42 participants
|
13 participants
|
37 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 7 to 14 days after the end of IV therapyPopulation: the population is the number of participants who are clinically evaluable
clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.
Outcome measures
| Measure |
VAP Treated With Doripenem
n=25 Participants
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
|
VAP Treated With Imipenem/Cilastatin
n=9 Participants
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
|
cIAI Treated With Doripenem
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
cIAI Treated With Imipenem/Cilastatin
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
|---|---|---|---|---|
|
Patients With VAP Who Were Clinically Cured
|
16 participants
|
7 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 to 14 days after the end of IV therapyPopulation: participants who were clinically evaluable
clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.
Outcome measures
| Measure |
VAP Treated With Doripenem
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
|
VAP Treated With Imipenem/Cilastatin
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
|
cIAI Treated With Doripenem
n=47 Participants
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
cIAI Treated With Imipenem/Cilastatin
n=14 Participants
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
|---|---|---|---|---|
|
Patients With cIAI Who Were Clinically Cured
|
—
|
—
|
39 participants
|
9 participants
|
Adverse Events
VAP Treated With Doripenem
Serious events: 16 serious events
Other events: 42 other events
Deaths: 0 deaths
VAP Treated With Imipenem/Cilastatin
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
cIAI Treated With Doripenem
Serious events: 11 serious events
Other events: 37 other events
Deaths: 0 deaths
cIAI Treated With Imipenem/Cilastatin
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAP Treated With Doripenem
n=48 participants at risk
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
|
VAP Treated With Imipenem/Cilastatin
n=15 participants at risk
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
|
cIAI Treated With Doripenem
n=61 participants at risk
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
cIAI Treated With Imipenem/Cilastatin
n=19 participants at risk
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
|---|---|---|---|---|
|
Nervous system disorders
Autonomic Nervous system imbalance
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Musculoskeletal and connective tissue disorders
Fascitis
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
abdominal abscess
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Blood and lymphatic system disorders
bradyarrhythmia
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Nervous system disorders
brain oedema
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Cardiac disorders
cardiac arrest
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Cardiac disorders
cardiac failure congestive
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Cardiac disorders
cardio-respiratory arrest
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
colonic fistura
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
endocarditis
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
gasrointestinal haemorrhage
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
gastritis
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Vascular disorders
haemorrhage
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Nervous system disorders
hydrocephalus
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Nervous system disorders
hypoglycaemic encephalopathy
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
intestinal infarction
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.7%
1/15 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
intestinal ischaemia
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Nervous system disorders
intracranial pressure increased
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.7%
1/15 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
megacolon
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
General disorders
multi-organ failure
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
pelvic abscess
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
pneumonia
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
13.3%
2/15 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
4.2%
2/48 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Renal and urinary disorders
renal failure
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Renal and urinary disorders
renal failure acute
|
4.2%
2/48 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
sepsis
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
3.3%
2/61 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
septic shock
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Injury, poisoning and procedural complications
suture rupture
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Cardiac disorders
ventricular arrhythmia
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
abscess
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
Other adverse events
| Measure |
VAP Treated With Doripenem
n=48 participants at risk
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
|
VAP Treated With Imipenem/Cilastatin
n=15 participants at risk
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
|
cIAI Treated With Doripenem
n=61 participants at risk
Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
cIAI Treated With Imipenem/Cilastatin
n=19 participants at risk
Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
9/48 • Number of events 9 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.7%
1/15 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
12.5%
6/48 • Number of events 6 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
constipation
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
20.0%
3/15 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
10.5%
2/19 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Skin and subcutaneous tissue disorders
decubitus ulcer
|
12.5%
6/48 • Number of events 6 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
diarrhoea
|
12.5%
6/48 • Number of events 6 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
13.3%
2/15 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
4.9%
3/61 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Vascular disorders
hypertension
|
4.2%
2/48 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.7%
1/15 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
11.5%
7/61 • Number of events 7 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
10.5%
2/19 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
4.2%
2/48 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.6%
4/61 • Number of events 4 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Metabolism and nutrition disorders
hypokalaemia
|
8.3%
4/48 • Number of events 4 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.7%
1/15 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.6%
4/61 • Number of events 4 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
15.8%
3/19 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Vascular disorders
hypotension
|
8.3%
4/48 • Number of events 4 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
3.3%
2/61 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Psychiatric disorders
insomnia
|
4.2%
2/48 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.7%
1/15 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
10.5%
2/19 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
nausea
|
4.2%
2/48 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
9.8%
6/61 • Number of events 6 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
pneumonia
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
13.3%
2/15 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
15.8%
3/19 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
General disorders
pyrexia
|
10.4%
5/48 • Number of events 5 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
13.3%
2/15 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
8.2%
5/61 • Number of events 5 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
15.8%
3/19 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
urinary tract infection
|
10.4%
5/48 • Number of events 5 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
20.0%
3/15 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Gastrointestinal disorders
Viomiting
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.7%
1/15 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
4.9%
3/61 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
General disorders
Oedema Peripheral
|
8.3%
4/48 • Number of events 4 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/48 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
4.9%
3/61 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
Urinary Tract Infection Fungal
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Infections and infestations
Wound Infection
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.7%
1/15 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
4.9%
3/61 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Investigations
Hepatic Enzyme Increased
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
6.6%
4/61 • Number of events 4 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Psychiatric disorders
Anxiety
|
4.2%
2/48 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
3.3%
2/61 • Number of events 2 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
8.3%
4/48 • Number of events 4 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
5.3%
1/19 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/61 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
6.2%
3/48 • Number of events 3 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/15 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
1.6%
1/61 • Number of events 1 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
0.00%
0/19 • All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy
|
Additional Information
Senior Director of Clinical Development
Johnson and Johnson Pharmaceutical Research and Development L.L.C.
Phone: 510 248-2310
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60