Trial Outcomes & Findings for Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects (NCT NCT02696902)
NCT ID: NCT02696902
Last Updated: 2021-02-04
Results Overview
Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
188 participants
Primary outcome timeframe
Day 1 through Day 22
Results posted on
2021-02-04
Participant Flow
A total of 188 participants were assigned to the study treatment groups. Out of 188 participants, 4 participants did not receive the study treatment.
Participant milestones
| Measure |
Placebo
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
16
|
87
|
|
Overall Study
Treated
|
83
|
16
|
85
|
|
Overall Study
Intent-to-treat (ITT) Population
|
85
|
16
|
87
|
|
Overall Study
As-treated Population
|
83
|
16
|
85
|
|
Overall Study
Modified Intent-to-treat (mITT) Population
|
83
|
16
|
85
|
|
Overall Study
COMPLETED
|
63
|
12
|
59
|
|
Overall Study
NOT COMPLETED
|
22
|
4
|
28
|
Reasons for withdrawal
| Measure |
Placebo
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Death
|
19
|
3
|
24
|
|
Overall Study
Participant not fit post-randomization
|
0
|
0
|
1
|
|
Overall Study
Participant not eligible (negative PCR)
|
0
|
0
|
1
|
|
Overall Study
Principal investigator's decision
|
1
|
0
|
0
|
|
Overall Study
Sponsor's decision
|
1
|
0
|
0
|
|
Overall Study
Transferred to other hospital
|
1
|
0
|
0
|
Baseline Characteristics
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=85 Participants
Of the 85 participants, 83 participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=16 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
n=87 Participants
Of the 87 participants, 85 participants received single IV dose of 1500 mg MEDI3902.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.4 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
62.7 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
60.6 Years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
62.5 Years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
77 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
176 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 22Population: The modified intent to treat (mITT) population included all randomized and treated participants, grouped according to assigned treatment.
Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Outcome measures
| Measure |
Placebo
n=83 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=16 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
n=85 Participants
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
|
18.1 Percentage of participants
|
12.5 Percentage of participants
|
22.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 50Population: The As-treated population is all treated participants, grouped according to actual treatment received.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Placebo
n=83 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=16 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
n=85 Participants
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
81 Participants
|
15 Participants
|
84 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 50Population: The As-treated population is all treated participants, grouped according to actual treatment received.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Placebo
n=83 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=16 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
n=85 Participants
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
|
35 Participants
|
4 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 50Population: The As-treated population is all treated participants, grouped according to actual treatment received.
An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious.
Outcome measures
| Measure |
Placebo
n=83 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=16 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
n=85 Participants
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50Population: The As-treated population is all treated participants, grouped according to actual treatment received. Number of Subjects Analyzed denotes the number of participants evaluated for this outcome measure.
The Cmax of MEDI3902 is reported.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=84 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of MEDI3902
|
87.6 mcg/mL
Standard Deviation 23.9
|
299 mcg/mL
Standard Deviation 94.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50Population: The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.
The AUC0-inf of MEDI3902 is reported.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=81 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902
|
440 day*mcg/mL
Standard Deviation 135
|
1510 day*mcg/mL
Standard Deviation 675
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50Population: The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.
The CL of MEDI3902 from body after intrevanous administration of single dose is reported.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=81 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Clearance (CL) of MEDI3902
|
1.31 L/day
Standard Deviation 0.638
|
1.27 L/day
Standard Deviation 0.86
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22Population: The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.
Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=84 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose
|
50 Percentage of participants
|
80.6 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50Population: The As-treated population is all treated participants, grouped according to actual treatment received. Number of participants analyzed denotes the number of participants evaluated for this outcome measure.
The t1/2 of MEDI3902 is reported.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=81 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of MEDI3902
|
6.56 day
Standard Deviation 4.03
|
5.65 day
Standard Deviation 2.69
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose), Day 15, Day 29, Day 50Population: The As-treated population is all treated participants, grouped according to actual treatment received.
Number of participants with positive ADA to MEDI3902 treatment is reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>= 2 post-baseline assessments.
Outcome measures
| Measure |
Placebo
n=83 Participants
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=16 Participants
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
n=85 Participants
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
Positive at baseline and post-baseline
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
Persistent positive
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
Transient positive
|
2 Participants
|
2 Participants
|
8 Participants
|
Adverse Events
Placebo
Serious events: 35 serious events
Other events: 79 other events
Deaths: 19 deaths
MEDI3902 500 mg
Serious events: 4 serious events
Other events: 15 other events
Deaths: 3 deaths
MEDI3902 1500 mg
Serious events: 38 serious events
Other events: 82 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Placebo
n=83 participants at risk
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=16 participants at risk
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
n=85 participants at risk
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Infections and infestations
Peritonitis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Pseudomonal sepsis
|
4.8%
4/83 • Number of events 4 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Septic shock
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Weaning failure
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Investigations
Oxygen saturation decreased
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Brain injury
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Coma
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Seizure
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Product Issues
Device occlusion
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Renal and urinary disorders
Polyuria
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haemorrhage
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Vascular disorders
Shock
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Cardiac disorders
Bradycardia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Cardiac arrest
|
6.0%
5/83 • Number of events 5 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Cardiac failure
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Myocarditis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Sinus node dysfunction
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Ear and labyrinth disorders
Deafness
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Chest pain
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Death
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
General physical health deterioration
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Multiple organ dysfunction syndrome
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
General disorders
Pyrexia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Bacterial sepsis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Biliary tract infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Brain abscess
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Bronchitis bacterial
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Burkholderia cepacia complex infection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Klebsiella bacteraemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
Other adverse events
| Measure |
Placebo
n=83 participants at risk
Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
|
MEDI3902 500 mg
n=16 participants at risk
Participants received single IV dose of 500 mg MEDI3902.
|
MEDI3902 1500 mg
n=85 participants at risk
Participants received single IV dose of 1500 mg MEDI3902.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Weaning failure
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
4/83 • Number of events 4 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Investigations
Blood albumin decreased
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Investigations
Blood glucose increased
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Investigations
Blood potassium decreased
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Investigations
Blood sodium decreased
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Investigations
Blood urea increased
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Investigations
C-reactive protein increased
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Investigations
Inflammatory marker increased
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Investigations
Oxygen saturation abnormal
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Investigations
Oxygen saturation decreased
|
3.6%
3/83 • Number of events 9 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 10 • Day 1 through Day 50
|
|
Investigations
Pco2 increased
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Investigations
Po2 decreased
|
1.2%
1/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 5 • Day 1 through Day 50
|
|
Investigations
Transaminases increased
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Investigations
Urine output decreased
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Investigations
White blood cell count increased
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 3 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 6 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 5 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 4 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
5.9%
5/85 • Number of events 5 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.8%
4/83 • Number of events 4 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.8%
9/83 • Number of events 12 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
17.6%
15/85 • Number of events 25 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 5 • Day 1 through Day 50
|
|
Metabolism and nutrition disorders
Vitamin k deficiency
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
4.8%
4/83 • Number of events 5 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
6.0%
5/83 • Number of events 9 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
9.4%
8/85 • Number of events 13 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
8.4%
7/83 • Number of events 10 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
12.5%
2/16 • Number of events 2 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 7 • Day 1 through Day 50
|
|
Cardiac disorders
Atrial tachycardia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Cardiac disorders
Bradycardia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 5 • Day 1 through Day 50
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Cardiogenic shock
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Cardiac disorders
Cyanosis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Sinus bradycardia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Cardiac disorders
Tachycardia
|
8.4%
7/83 • Number of events 11 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Endocrine disorders
Adrenal insufficiency
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Endocrine disorders
Euthyroid sick syndrome
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Eye disorders
Blindness unilateral
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Eye disorders
Dry eye
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Eye disorders
Noninfective conjunctivitis
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Eye disorders
Ocular hyperaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Eye disorders
Pupils unequal
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Abdominal pain
|
7.2%
6/83 • Number of events 6 • Day 1 through Day 50
|
12.5%
2/16 • Number of events 3 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 6 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Anal incontinence
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Constipation
|
13.3%
11/83 • Number of events 13 • Day 1 through Day 50
|
25.0%
4/16 • Number of events 5 • Day 1 through Day 50
|
12.9%
11/85 • Number of events 11 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
11/83 • Number of events 16 • Day 1 through Day 50
|
25.0%
4/16 • Number of events 5 • Day 1 through Day 50
|
14.1%
12/85 • Number of events 14 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
7.1%
6/85 • Number of events 6 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Lip haemorrhage
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Melaena
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Nausea
|
3.6%
3/83 • Number of events 5 • Day 1 through Day 50
|
25.0%
4/16 • Number of events 5 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 2 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Oesophagopleural fistula
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Oral mucosa haematoma
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Perianal erythema
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 2 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
3/83 • Number of events 5 • Day 1 through Day 50
|
12.5%
2/16 • Number of events 4 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 6 • Day 1 through Day 50
|
|
General disorders
Asthenia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Catheter site inflammation
|
2.4%
2/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
General disorders
Catheter site pain
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Chills
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
General disorders
Complication associated with device
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
General disorders
Generalised oedema
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
General disorders
Granuloma
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Hyperthermia
|
2.4%
2/83 • Number of events 4 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
General disorders
Hypothermia
|
2.4%
2/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 3 • Day 1 through Day 50
|
|
General disorders
Localised oedema
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Medical device pain
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Medical device site haemorrhage
|
1.2%
1/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
General disorders
Mucosal ulceration
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
General disorders
Oedema peripheral
|
4.8%
4/83 • Number of events 4 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 4 • Day 1 through Day 50
|
|
General disorders
Pain
|
9.6%
8/83 • Number of events 15 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
8.2%
7/85 • Number of events 7 • Day 1 through Day 50
|
|
General disorders
Peripheral swelling
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
General disorders
Pyrexia
|
15.7%
13/83 • Number of events 20 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
18.8%
16/85 • Number of events 20 • Day 1 through Day 50
|
|
General disorders
Swelling
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
General disorders
Thirst
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Hepatobiliary disorders
Cholestasis
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Hepatobiliary disorders
Hepatocellular injury
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Acinetobacter infection
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
5.9%
5/85 • Number of events 5 • Day 1 through Day 50
|
|
Infections and infestations
Anal fungal infection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Bacteraemia
|
4.8%
4/83 • Number of events 4 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 5 • Day 1 through Day 50
|
|
Infections and infestations
Bacterial abdominal infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Bacterial disease carrier
|
1.2%
1/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 5 • Day 1 through Day 50
|
|
Infections and infestations
Bacterial infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Infections and infestations
Bacteriuria
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Bronchitis bacterial
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Candida infection
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Candiduria
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Cellulitis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Citrobacter bacteraemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 3 • Day 1 through Day 50
|
|
Infections and infestations
Conjunctivitis
|
1.2%
1/83 • Number of events 3 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Cystitis klebsiella
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Empyema
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Endocarditis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Enterobacter bacteraemia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Enterobacter pneumonia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Enterococcal infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Enterococcal sepsis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Escherichia bacteraemia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Escherichia urinary tract infection
|
6.0%
5/83 • Number of events 5 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 2 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 4 • Day 1 through Day 50
|
|
Infections and infestations
Eye infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Fungaemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Fungal skin infection
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Genital infection female
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Herpes virus infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Influenza
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Klebsiella bacteraemia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Klebsiella sepsis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Lung infection pseudomonal
|
2.4%
2/83 • Number of events 5 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Morganella infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Oral candidiasis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Infections and infestations
Oral fungal infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Oral herpes
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Oropharyngeal candidiasis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Infections and infestations
Pneumonia acinetobacter
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Pneumonia bacterial
|
14.5%
12/83 • Number of events 13 • Day 1 through Day 50
|
12.5%
2/16 • Number of events 2 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 5 • Day 1 through Day 50
|
|
Infections and infestations
Pneumonia escherichia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Pneumonia proteus
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Pneumonia pseudomonal
|
14.5%
12/83 • Number of events 13 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
15.3%
13/85 • Number of events 15 • Day 1 through Day 50
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Proteus infection
|
4.8%
4/83 • Number of events 4 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 2 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Pseudomonal bacteraemia
|
7.2%
6/83 • Number of events 6 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
7.1%
6/85 • Number of events 6 • Day 1 through Day 50
|
|
Infections and infestations
Pseudomonal sepsis
|
6.0%
5/83 • Number of events 6 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Pseudomonas bronchitis
|
6.0%
5/83 • Number of events 5 • Day 1 through Day 50
|
25.0%
4/16 • Number of events 4 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Infections and infestations
Pseudomonas infection
|
4.8%
4/83 • Number of events 4 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Infections and infestations
Pyuria
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Septic shock
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Serratia bacteraemia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Serratia sepsis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Staphylococcal sepsis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Stoma site infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Systemic candida
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 2 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Infections and infestations
Urinary tract infection bacterial
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
6.0%
5/83 • Number of events 6 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Varicella zoster virus infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Eschar
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Flail chest
|
1.2%
1/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Haemodilution
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Overdose
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Palate injury
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Postoperative hypotension
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Scar
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Scratch
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Stoma site erythema
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 2 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Exposed bone in jaw
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 3 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.6%
3/83 • Number of events 4 • Day 1 through Day 50
|
18.8%
3/16 • Number of events 3 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Nervous system disorders
Aphasia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Complex regional pain syndrome
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Epilepsy
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Frontotemporal dementia
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Headache
|
2.4%
2/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 7 • Day 1 through Day 50
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Loss of consciousness
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Paresis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Nervous system disorders
Post cardiac arrest syndrome
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Psychomotor hyperactivity
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Seizure
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Somnolence
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Nervous system disorders
Syncope
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Nervous system disorders
Tremor
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Product Issues
Stent malfunction
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Product Issues
Thrombosis in device
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Psychiatric disorders
Agitation
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Psychiatric disorders
Anxiety
|
4.8%
4/83 • Number of events 5 • Day 1 through Day 50
|
18.8%
3/16 • Number of events 3 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Psychiatric disorders
Apathy
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Psychiatric disorders
Compulsive lip biting
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Psychiatric disorders
Delirium
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
5.9%
5/85 • Number of events 5 • Day 1 through Day 50
|
|
Psychiatric disorders
Depression
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Psychiatric disorders
Depressive symptom
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Psychiatric disorders
Disorientation
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Psychiatric disorders
Initial insomnia
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Psychiatric disorders
Insomnia
|
10.8%
9/83 • Number of events 10 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
8.2%
7/85 • Number of events 7 • Day 1 through Day 50
|
|
Psychiatric disorders
Intensive care unit delirium
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Renal and urinary disorders
Anuria
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Renal and urinary disorders
Oliguria
|
6.0%
5/83 • Number of events 6 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
5.9%
5/85 • Number of events 5 • Day 1 through Day 50
|
|
Renal and urinary disorders
Polyuria
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Renal and urinary disorders
Renal failure
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
5.9%
5/85 • Number of events 5 • Day 1 through Day 50
|
|
Renal and urinary disorders
Renal impairment
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Renal and urinary disorders
Urinary tract disorder
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Renal and urinary disorders
Urine abnormality
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Renal and urinary disorders
Vesical fistula
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Reproductive system and breast disorders
Cervical cyst
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Reproductive system and breast disorders
Penile oedema
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Reproductive system and breast disorders
Vulval disorder
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
1.2%
1/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.8%
4/83 • Number of events 5 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
4.7%
4/85 • Number of events 4 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.4%
2/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 2 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
5.9%
5/85 • Number of events 8 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
3.6%
3/83 • Number of events 3 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/83 • Day 1 through Day 50
|
12.5%
2/16 • Number of events 2 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
18.8%
3/16 • Number of events 3 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 4 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 5 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory fatigue
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
2.4%
2/83 • Number of events 2 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
2.4%
2/83 • Number of events 3 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 3 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
7.2%
6/83 • Number of events 6 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
5.9%
5/85 • Number of events 6 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.6%
3/83 • Number of events 5 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/83 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 5 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 2 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
2.4%
2/85 • Number of events 2 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Artery dissection
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Hypertension
|
8.4%
7/83 • Number of events 9 • Day 1 through Day 50
|
18.8%
3/16 • Number of events 5 • Day 1 through Day 50
|
3.5%
3/85 • Number of events 6 • Day 1 through Day 50
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Hypotension
|
19.3%
16/83 • Number of events 21 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
27.1%
23/85 • Number of events 29 • Day 1 through Day 50
|
|
Vascular disorders
Jugular vein thrombosis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Vascular disorders
Peripheral coldness
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Vascular disorders
Phlebitis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Thrombosis
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Vascular disorders
Vein disorder
|
1.2%
1/83 • Number of events 1 • Day 1 through Day 50
|
6.2%
1/16 • Number of events 1 • Day 1 through Day 50
|
0.00%
0/85 • Day 1 through Day 50
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/83 • Day 1 through Day 50
|
0.00%
0/16 • Day 1 through Day 50
|
1.2%
1/85 • Number of events 1 • Day 1 through Day 50
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER