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Trial record 1 of 1 for:    NCT02296320
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Study of the Efficacy and Safety of MEDI4893 (SAATELLITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296320
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : October 25, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborators:
Innovative Medicines Initiative and COMBACTE-NET
Antibacterial Resistance Leadership Group
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Staphylococcus Aureus Pneumonia
Interventions Drug: MEDI4893
Other: Placebo
Enrollment 213
Recruitment Details The study was conducted between 10Oct2014 and 02Oct2018.
Pre-assignment Details A total of 767 participants consented to participate in the study, of which 554 were screen failures. A total of 213 participants were randomized in the study.
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study. Participants received a single IV dose of MEDI4893 2000 milligrams (mg) on Day 1 of the study. Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Period Title: Overall Study
Started 102 15 96
Treated 100 15 96
Completed 67 10 59
Not Completed 35 5 37
Reason Not Completed
Withdrawal by Subject             4             0             2
Death             24             3             27
Lost to Follow-up             5             2             7
Not treated             2             0             0
Not - specified             0             0             1
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg Total
Hide Arm/Group Description Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study. Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study. Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study. Total of all reporting groups
Overall Number of Baseline Participants 100 15 96 211
Hide Baseline Analysis Population Description
Modified Intent-to-treat (mITT) population included all participants, who received any dose of study drug and analyzed according to their randomized treatment group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 15 participants 96 participants 211 participants
55.7  (16.6) 52.5  (14.6) 57.7  (15.7) 56.4  (16.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 15 participants 96 participants 211 participants
Female
45
  45.0%
5
  33.3%
37
  38.5%
87
  41.2%
Male
55
  55.0%
10
  66.7%
59
  61.5%
124
  58.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 15 participants 96 participants 211 participants
Hispanic or Latino
4
   4.0%
0
   0.0%
4
   4.2%
8
   3.8%
Not Hispanic or Latino
96
  96.0%
15
 100.0%
92
  95.8%
203
  96.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 15 participants 96 participants 211 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   6.7%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   3.0%
1
   6.7%
2
   2.1%
6
   2.8%
White
97
  97.0%
13
  86.7%
94
  97.9%
204
  96.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia
Hide Description The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio < 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by >= 50 mmHg maintained for at least 4 hrs or a need to initiate non-invasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).
Time Frame Day 1 through Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
An mITT population included all participants, who received any dose of study drug and analyzed according to their randomized treatment group.
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 100 15 96
Measure Type: Number
Unit of Measure: Percentage of Participants
26.0 20.0 17.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI4893 5000 mg
Comments The key efficacy analyses were based on 5000 mg MEDI4893 and placebo. Participants who received 2000 mg MEDI4893 were summarized descriptively.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments [Not Specified]
Method Poisson regression with robust variance
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative risk reduction
Estimated Value 31.9
Confidence Interval (2-Sided) 90%
-7.5 to 56.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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.
Time Frame Day 1 through Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 100 15 96
Measure Type: Count of Participants
Unit of Measure: Participants
90
  90.0%
15
 100.0%
87
  90.6%
3.Primary Outcome
Title Number of Participants With TEAEs Through 91 Days
Hide Description An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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.
Time Frame Day 1 through Day 91
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 100 15 96
Measure Type: Count of Participants
Unit of Measure: Participants
92
  92.0%
15
 100.0%
89
  92.7%
4.Primary Outcome
Title Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Hide Description A serious adverse event (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. 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.
Time Frame Day 1 through Day 191
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 100 15 96
Measure Type: Count of Participants
Unit of Measure: Participants
40
  40.0%
7
  46.7%
50
  52.1%
5.Primary Outcome
Title Number of Participants With Adverse Events of Special Interest (AESIs)
Hide Description An AESI is one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious.
Time Frame Day 1 through Day 191
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 100 15 96
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4
  26.7%
3
   3.1%
6.Primary Outcome
Title Number of Participants With New Onset Chronic Diseases (NOCDs)
Hide Description An NOCD defined as a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving the study drug and is assessed by the investigator as medically significant.
Time Frame Day 1 through Day 191
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 100 15 96
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.0%
0
   0.0%
3
   3.1%
7.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of MEDI4893
Hide Description Maximum observed serum concentration (Cmax) of MEDI4893 is reported.
Time Frame Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 91
Hide Outcome Measure Data
Hide Analysis Population Description
An Intent-to-treat (ITT) population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable pharmacokinetic (PK) samples were analyzed for this outcome measure.
Arm/Group Title MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 14 94
Mean (Standard Deviation)
Unit of Measure: μg/mL
471.9  (123.0) 1143.7  (375.6)
8.Secondary Outcome
Title Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893
Hide Description Area under the serum concentration time curve from time zero to last measurable concentration (AUC[0 - Last]) of MEDI4893 is reported.
Time Frame Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 91
Hide Outcome Measure Data
Hide Analysis Population Description
An ITT population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable PK samples were analyzed for this outcome measure.
Arm/Group Title MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 14 94
Mean (Standard Deviation)
Unit of Measure: day*μg/mL
9045.5  (5383.1) 20127.5  (12852.2)
9.Secondary Outcome
Title Observed Serum Concentration of MEDI4893 Through 30 Days Post Dose (C30)
Hide Description Observed serum concentration of MEDI4893 through 30 days post dose (C30) is reported. Serum concentration of MEDI4893 through 30 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, and 30).
Time Frame Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, and 30
Hide Outcome Measure Data
Hide Analysis Population Description
An ITT population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable PK samples were analyzed for this outcome measure.
Arm/Group Title MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 13 68
Mean (Standard Deviation)
Unit of Measure: μg/mL
122.0  (65.0) 295.9  (130.6)
10.Secondary Outcome
Title Observed Serum Concentration of MEDI4893 Through 90 Days Post Dose (C90)
Hide Description Observed serum concentration of MEDI4893 through 90 days post dose (C90) is reported. Serum concentration of MEDI4893 through 90 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, 31, 61, and 91).
Time Frame Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 90
Hide Outcome Measure Data
Hide Analysis Population Description
An ITT population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable PK samples were analyzed for this outcome measure.
Arm/Group Title MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 11 54
Mean (Standard Deviation)
Unit of Measure: μg/mL
71.5  (35.5) 192.0  (84.0)
11.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893
Hide Description Participants with ADA-positive at any of Day 31, Day 61, or Day 91 post-baseline assessments were always counted as "positive" at post-baseline.
Time Frame Pre-dose on Day 1 (Baseline); and on Days 31, 61, and 91
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description:
Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study.
Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
Overall Number of Participants Analyzed 100 15 96
Measure Type: Count of Participants
Unit of Measure: Participants
Positive at baseline
3
   3.0%
0
   0.0%
2
   2.1%
Positive post-baseline
5
   5.0%
0
   0.0%
0
   0.0%
Positive at baseline and post-baseline
2
   2.0%
0
   0.0%
0
   0.0%
Not detected at baseline; positive post-baseline
3
   3.0%
0
   0.0%
0
   0.0%
Positive at baseline; not detected post-baseline
0
   0.0%
0
   0.0%
1
   1.0%
Time Frame SAEs: Day 1 through Day 191 AEs: Day 1 through Day 91
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Hide Arm/Group Description Participants received a single IV dose of placebo matched to MEDI4893 on Day 1 of the study. Participants received a single IV dose of MEDI4893 2000 mg on Day 1 of the study. Participants received a single IV dose of MEDI4893 5000 mg on Day 1 of the study.
All-Cause Mortality
Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/100 (24.00%)      3/15 (20.00%)      27/96 (28.13%)    
Hide Serious Adverse Events
Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/100 (40.00%)      7/15 (46.67%)      50/96 (52.08%)    
Blood and lymphatic system disorders       
Anaemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Cardiac disorders       
Bradycardia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Cardiac arrest  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Cardiac failure  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Cardiac failure congestive  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Cardio-respiratory arrest  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Congestive cardiomyopathy  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Gastrointestinal haemorrhage  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Intestinal ischaemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Strangulated umbilical hernia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
General disorders       
Brain death  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Multiple organ dysfunction syndrome  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  1
Hepatobiliary disorders       
Hepatocellular injury  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Infections and infestations       
Acinetobacter infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Bacteraemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Bacterial sepsis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Brain abscess  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Bronchitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Clostridium difficile colitis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Creutzfeldt-jakob disease  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Device related infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Escherichia sepsis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Infectious pleural effusion  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Klebsiella infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Klebsiella sepsis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Meningitis enterococcal  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Meningitis staphylococcal  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Pneumonia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumonia bacterial  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Pneumonia klebsiella  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Pneumonia pseudomonal  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumonia serratia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Pneumonia staphylococcal  1  3/100 (3.00%)  3 0/15 (0.00%)  0 1/96 (1.04%)  1
Pseudomonal sepsis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Sepsis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Septic shock  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Serratia infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Serratia sepsis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Staphylococcal bacteraemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Staphylococcal infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Staphylococcal sepsis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Urinary tract infection pseudomonal  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Injury, poisoning and procedural complications       
Extradural haematoma  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Infusion related reaction  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Tracheostomy malfunction  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Vascular pseudoaneurysm  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Weaning failure  1  3/100 (3.00%)  3 0/15 (0.00%)  0 1/96 (1.04%)  1
Investigations       
Coma scale abnormal  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Brain neoplasm  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Glioblastoma  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Glioma  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hepatocellular carcinoma  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Laryngeal cancer  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Nervous system disorders       
Brain hypoxia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Brain oedema  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Brain stem stroke  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Cerebral haemorrhage  1  1/100 (1.00%)  1 1/15 (6.67%)  1 2/96 (2.08%)  2
Coma  1  1/100 (1.00%)  1 1/15 (6.67%)  2 5/96 (5.21%)  5
Depressed level of consciousness  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Epilepsy  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Haemorrhage intracranial  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Haemorrhagic stroke  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hydrocephalus  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Hypercapnic coma  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypoxic-ischaemic encephalopathy  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Intracranial pressure increased  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Intraventricular haemorrhage  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Ischaemic stroke  1  0/100 (0.00%)  0 0/15 (0.00%)  0 3/96 (3.13%)  3
Multiple system atrophy  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Myasthenia gravis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  2
Nervous system disorder  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Neuralgia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Neurological decompensation  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Partial seizures  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Ruptured cerebral aneurysm  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Status epilepticus  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Vocal cord paralysis  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Product Issues       
Device malfunction  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  1
Aspiration  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Bronchospasm  1  1/100 (1.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Haemoptysis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypoxia  1  3/100 (3.00%)  3 1/15 (6.67%)  1 0/96 (0.00%)  0
Laryngeal oedema  1  1/100 (1.00%)  2 0/15 (0.00%)  0 2/96 (2.08%)  2
Obstructive airways disorder  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Pleural effusion  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumonia aspiration  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Pulmonary embolism  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Respiratory arrest  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Respiratory failure  1  0/100 (0.00%)  0 1/15 (6.67%)  1 5/96 (5.21%)  5
Stridor  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Vascular disorders       
Deep vein thrombosis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypotension  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Shock haemorrhagic  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo MEDI4893 2000 mg MEDI4893 5000 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/100 (90.00%)      15/15 (100.00%)      85/96 (88.54%)    
Blood and lymphatic system disorders       
Anaemia  1  12/100 (12.00%)  24 2/15 (13.33%)  2 11/96 (11.46%)  11
Coagulopathy  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Iron deficiency anaemia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Leukopenia  1  1/100 (1.00%)  1 1/15 (6.67%)  1 0/96 (0.00%)  0
Normochromic anaemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Thrombocytopenia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Thrombocytosis  1  3/100 (3.00%)  3 1/15 (6.67%)  1 6/96 (6.25%)  6
Cardiac disorders       
Acute myocardial infarction  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Arrhythmia  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Arrhythmia supraventricular  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Atrial fibrillation  1  3/100 (3.00%)  3 1/15 (6.67%)  1 2/96 (2.08%)  2
Atrial flutter  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Atrial thrombosis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Atrioventricular block complete  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Atrioventricular block second degree  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Bradycardia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Cardiac arrest  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Cardiac failure  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Left ventricular dysfunction  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Mitral valve incompetence  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Pericardial effusion  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Sinus tachycardia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Supraventricular tachycardia  1  1/100 (1.00%)  1 1/15 (6.67%)  1 0/96 (0.00%)  0
Tachycardia  1  3/100 (3.00%)  3 0/15 (0.00%)  0 3/96 (3.13%)  3
Ventricular extrasystoles  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Ventricular tachycardia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Congenital, familial and genetic disorders       
Muscular dystrophy  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Right-to-left cardiac shunt  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Ear and labyrinth disorders       
Excessive cerumen production  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Vertigo  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Endocrine disorders       
Diabetes insipidus  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Goitre  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Hyperthyroidism  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypothyroidism  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Eye disorders       
Conjunctival haemorrhage  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Eyelid ptosis  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Keratitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Abdominal pain  1  4/100 (4.00%)  5 1/15 (6.67%)  1 1/96 (1.04%)  1
Abdominal pain upper  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Barrett's oesophagus  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Constipation  1  15/100 (15.00%)  16 1/15 (6.67%)  1 7/96 (7.29%)  7
Diarrhoea  1  8/100 (8.00%)  11 3/15 (20.00%)  4 8/96 (8.33%)  13
Dysphagia  1  3/100 (3.00%)  3 0/15 (0.00%)  0 4/96 (4.17%)  4
Faecaloma  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Gastritis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Gastrointestinal haemorrhage  1  5/100 (5.00%)  5 0/15 (0.00%)  0 1/96 (1.04%)  1
Gastrointestinal hypomotility  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Gastrointestinal obstruction  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Gastrooesophageal reflux disease  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Haematemesis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  2
Ileus paralytic  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Impaired gastric emptying  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Nausea  1  3/100 (3.00%)  3 0/15 (0.00%)  0 4/96 (4.17%)  5
Oesophagitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Oral pain  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pancreatic disorder  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Salivary hypersecretion  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Vomiting  1  6/100 (6.00%)  6 0/15 (0.00%)  0 0/96 (0.00%)  0
General disorders       
Catheter site haematoma  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Chills  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Generalised oedema  1  3/100 (3.00%)  3 0/15 (0.00%)  0 1/96 (1.04%)  1
Hyperthermia  1  3/100 (3.00%)  4 0/15 (0.00%)  0 1/96 (1.04%)  1
Hypothermia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Implant site haematoma  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Infusion site extravasation  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Localised oedema  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Medical device site pain  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Non-cardiac chest pain  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Oedema peripheral  1  3/100 (3.00%)  3 1/15 (6.67%)  1 0/96 (0.00%)  0
Pain  1  3/100 (3.00%)  3 0/15 (0.00%)  0 3/96 (3.13%)  3
Pyrexia  1  15/100 (15.00%)  26 2/15 (13.33%)  5 8/96 (8.33%)  9
Vascular complication associated with device  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Hepatobiliary disorders       
Biliary cirrhosis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Cholestasis  1  4/100 (4.00%)  4 4/15 (26.67%)  4 7/96 (7.29%)  7
Hepatic function abnormal  1  0/100 (0.00%)  0 2/15 (13.33%)  3 0/96 (0.00%)  0
Hepatocellular injury  1  5/100 (5.00%)  5 4/15 (26.67%)  4 6/96 (6.25%)  6
Hyperbilirubinaemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypertransaminasaemia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Jaundice cholestatic  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Liver disorder  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Infections and infestations       
Abscess bacterial  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Acinetobacter bacteraemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Bacteraemia  1  2/100 (2.00%)  2 0/15 (0.00%)  0 2/96 (2.08%)  2
Bacterial disease carrier  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Bacterial pyelonephritis  1  1/100 (1.00%)  1 1/15 (6.67%)  1 0/96 (0.00%)  0
Bacterial sepsis  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Bacteroides bacteraemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Bronchitis bacterial  1  5/100 (5.00%)  6 0/15 (0.00%)  0 2/96 (2.08%)  2
Bronchitis pneumococcal  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Citrobacter infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Citrobacter sepsis  1  1/100 (1.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Clostridium difficile colitis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Conjunctivitis  1  2/100 (2.00%)  4 0/15 (0.00%)  0 2/96 (2.08%)  2
Cystitis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Cytomegalovirus infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Device related infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Enterobacter bacteraemia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Enterobacter infection  1  0/100 (0.00%)  0 1/15 (6.67%)  2 0/96 (0.00%)  0
Enterobacter pneumonia  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Enterococcal bacteraemia  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Enterococcal infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Enterococcal sepsis  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Epididymitis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Escherichia bacteraemia  1  2/100 (2.00%)  2 1/15 (6.67%)  1 0/96 (0.00%)  0
Escherichia infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Escherichia sepsis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Escherichia urinary tract infection  1  14/100 (14.00%)  18 4/15 (26.67%)  4 18/96 (18.75%)  23
Fungal infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Fungal skin infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Genital herpes  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Haemophilus infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Helicobacter gastritis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Herpes zoster  1  1/100 (1.00%)  1 1/15 (6.67%)  1 0/96 (0.00%)  0
Infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Infectious pleural effusion  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Klebsiella bacteraemia  1  3/100 (3.00%)  3 0/15 (0.00%)  0 0/96 (0.00%)  0
Klebsiella infection  1  2/100 (2.00%)  2 1/15 (6.67%)  1 2/96 (2.08%)  2
Laryngitis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Localised infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Meningitis bacterial  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Moraxella infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Morganella infection  1  3/100 (3.00%)  5 0/15 (0.00%)  0 2/96 (2.08%)  2
Nasopharyngitis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Oral candidiasis  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  1
Oropharyngeal candidiasis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Otitis externa  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Otitis media  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumonia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Pneumonia bacterial  1  17/100 (17.00%)  17 1/15 (6.67%)  1 7/96 (7.29%)  7
Pneumonia escherichia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  2
Pneumonia haemophilus  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Pneumonia klebsiella  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumonia moraxella  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Pneumonia pseudomonal  1  4/100 (4.00%)  4 0/15 (0.00%)  0 0/96 (0.00%)  0
Pneumonia serratia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumonia staphylococcal  1  13/100 (13.00%)  13 2/15 (13.33%)  2 13/96 (13.54%)  13
Postoperative wound infection  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Proteus infection  1  0/100 (0.00%)  0 1/15 (6.67%)  1 2/96 (2.08%)  2
Pseudomembranous colitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Pseudomonal bacteraemia  1  1/100 (1.00%)  1 1/15 (6.67%)  1 0/96 (0.00%)  0
Pseudomonas bronchitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Pseudomonas infection  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Puncture site abscess  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Serratia bacteraemia  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Serratia infection  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  1
Sinusitis  1  3/100 (3.00%)  3 0/15 (0.00%)  0 2/96 (2.08%)  2
Staphylococcal bacteraemia  1  6/100 (6.00%)  7 1/15 (6.67%)  1 3/96 (3.13%)  3
Staphylococcal infection  1  4/100 (4.00%)  5 0/15 (0.00%)  0 4/96 (4.17%)  4
Staphylococcal sepsis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Staphylococcal skin infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Streptococcal bacteraemia  1  1/100 (1.00%)  1 1/15 (6.67%)  1 2/96 (2.08%)  2
Streptococcal infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Systemic infection  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Tracheobronchitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Urinary tract infection  1  2/100 (2.00%)  2 0/15 (0.00%)  0 2/96 (2.08%)  4
Urinary tract infection bacterial  1  2/100 (2.00%)  2 1/15 (6.67%)  1 3/96 (3.13%)  3
Urinary tract infection fungal  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Urinary tract infection pseudomonal  1  3/100 (3.00%)  3 1/15 (6.67%)  1 4/96 (4.17%)  4
Urinary tract infection staphylococcal  1  2/100 (2.00%)  2 1/15 (6.67%)  1 0/96 (0.00%)  0
Viral upper respiratory tract infection  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Vulvovaginal candidiasis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Wound infection bacterial  1  2/100 (2.00%)  2 0/15 (0.00%)  0 3/96 (3.13%)  3
Wound infection staphylococcal  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Injury, poisoning and procedural complications       
Endotracheal intubation complication  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Eschar  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Facial bones fracture  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Fall  1  2/100 (2.00%)  2 0/15 (0.00%)  0 2/96 (2.08%)  2
Infusion related reaction  1  0/100 (0.00%)  0 1/15 (6.67%)  1 2/96 (2.08%)  2
Mechanical ventilation complication  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Post procedural haematoma  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Postoperative wound complication  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Procedural haemorrhage  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Procedural hypotension  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Procedural pain  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Spinal compression fracture  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Tracheostomy malfunction  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Traumatic shock  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Unintentional medical device removal  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Vasoplegia syndrome  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Weaning failure  1  2/100 (2.00%)  2 1/15 (6.67%)  1 3/96 (3.13%)  3
Investigations       
Alanine aminotransferase increased  1  0/100 (0.00%)  0 1/15 (6.67%)  1 2/96 (2.08%)  2
Aspartate aminotransferase increased  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Blood lactate dehydrogenase increased  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Blood potassium decreased  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Body temperature increased  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Gamma-glutamyltransferase increased  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Haemoglobin decreased  1  0/100 (0.00%)  0 1/15 (6.67%)  3 0/96 (0.00%)  0
Hepatic enzyme increased  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
International normalised ratio increased  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Liver function test abnormal  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Mononucleosis heterophile test positive  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Pancreatic enzymes increased  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Transaminases increased  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Weight decreased  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Metabolism and nutrition disorders       
Cerebral salt-wasting syndrome  1  1/100 (1.00%)  1 1/15 (6.67%)  1 0/96 (0.00%)  0
Fluid overload  1  0/100 (0.00%)  0 1/15 (6.67%)  2 1/96 (1.04%)  1
Folate deficiency  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Gout  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  2
Hyperglycaemia  1  4/100 (4.00%)  4 1/15 (6.67%)  1 1/96 (1.04%)  1
Hyperkalaemia  1  2/100 (2.00%)  2 1/15 (6.67%)  2 2/96 (2.08%)  2
Hyperlactacidaemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypernatraemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Hypoalbuminaemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypocalcaemia  1  2/100 (2.00%)  3 0/15 (0.00%)  0 2/96 (2.08%)  2
Hypoglycaemia  1  2/100 (2.00%)  3 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypokalaemia  1  7/100 (7.00%)  9 1/15 (6.67%)  2 11/96 (11.46%)  13
Hypomagnesaemia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Hyponatraemia  1  4/100 (4.00%)  5 1/15 (6.67%)  1 4/96 (4.17%)  5
Hypophosphataemia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 4/96 (4.17%)  4
Hypoproteinaemia  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  1
Hypovolaemia  1  0/100 (0.00%)  0 1/15 (6.67%)  3 0/96 (0.00%)  0
Iron deficiency  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Metabolic alkalosis  1  3/100 (3.00%)  3 0/15 (0.00%)  0 0/96 (0.00%)  0
Vitamin b12 deficiency  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Vitamin k deficiency  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Musculoskeletal and connective tissue disorders       
Amyotrophy  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Arthralgia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Back pain  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Bone pain  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Joint stiffness  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Muscle haemorrhage  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Muscular weakness  1  1/100 (1.00%)  1 0/15 (0.00%)  0 3/96 (3.13%)  3
Musculoskeletal pain  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Myalgia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Myopathy  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Neck pain  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Pain in extremity  1  3/100 (3.00%)  3 0/15 (0.00%)  0 2/96 (2.08%)  3
Torticollis  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Leiomyoma  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Osteoma  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Nervous system disorders       
Altered state of consciousness  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Aphasia  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Aphonia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Cerebral ischaemia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Cerebrovascular accident  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Cognitive disorder  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Diabetic hyperosmolar coma  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Disturbance in attention  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Dysaesthesia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Dysarthria  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Encephalitis autoimmune  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Epilepsy  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Generalised tonic-clonic seizure  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Headache  1  3/100 (3.00%)  3 1/15 (6.67%)  1 2/96 (2.08%)  3
Hemiplegia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Hypoglossal nerve paralysis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Intracranial pressure increased  1  0/100 (0.00%)  0 1/15 (6.67%)  1 2/96 (2.08%)  2
Multiple system atrophy  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Muscle tone disorder  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Myasthenia gravis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Myelopathy  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Myoclonic epilepsy  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Neuralgia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Neurological decompensation  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Paraplegia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Quadriplegia  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Sciatica  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Seizure  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Subdural hygroma  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Vasculitis cerebral  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Vocal cord paresis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Psychiatric disorders       
Aggression  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Agitation  1  3/100 (3.00%)  4 0/15 (0.00%)  0 6/96 (6.25%)  6
Anxiety  1  5/100 (5.00%)  5 1/15 (6.67%)  1 8/96 (8.33%)  8
Confusional state  1  2/100 (2.00%)  2 1/15 (6.67%)  1 5/96 (5.21%)  7
Delirium  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Depression  1  2/100 (2.00%)  2 1/15 (6.67%)  1 4/96 (4.17%)  4
Flat affect  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Hallucination, visual  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Initial insomnia  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Insomnia  1  4/100 (4.00%)  4 1/15 (6.67%)  1 5/96 (5.21%)  5
Organic brain syndrome  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Stress  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Renal and urinary disorders       
Acute kidney injury  1  1/100 (1.00%)  1 1/15 (6.67%)  1 2/96 (2.08%)  2
Bladder spasm  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Chronic kidney disease  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Haematuria  1  0/100 (0.00%)  0 2/15 (13.33%)  2 2/96 (2.08%)  2
Hypertonic bladder  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Oliguria  1  1/100 (1.00%)  1 0/15 (0.00%)  0 3/96 (3.13%)  3
Polyuria  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Renal failure  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Renal impairment  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Urinary retention  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Reproductive system and breast disorders       
Male genital tract fistula  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Prostatitis  1  1/100 (1.00%)  1 1/15 (6.67%)  1 0/96 (0.00%)  0
Vaginal discharge  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  2
Acute respiratory distress syndrome  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Acute respiratory failure  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Asthma  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Atelectasis  1  3/100 (3.00%)  5 1/15 (6.67%)  1 7/96 (7.29%)  7
Bronchial disorder  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Bronchial hyperreactivity  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Bronchial obstruction  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Bronchial secretion retention  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Bronchospasm  1  4/100 (4.00%)  4 0/15 (0.00%)  0 2/96 (2.08%)  2
Chronic obstructive pulmonary disease  1  1/100 (1.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Cough  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Dysphonia  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Dyspnoea  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Epistaxis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Haemoptysis  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Hiccups  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Hypercapnia  1  2/100 (2.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Hypoxia  1  2/100 (2.00%)  6 1/15 (6.67%)  1 0/96 (0.00%)  0
Increased bronchial secretion  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  1
Increased viscosity of bronchial secretion  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  1
Laryngeal dyspnoea  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Laryngeal granuloma  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Laryngeal oedema  1  6/100 (6.00%)  6 2/15 (13.33%)  2 1/96 (1.04%)  1
Laryngeal pain  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Laryngeal ulceration  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Lung disorder  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Oropharyngeal pain  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pleural effusion  1  4/100 (4.00%)  5 0/15 (0.00%)  0 6/96 (6.25%)  6
Pneumomediastinum  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumonia aspiration  1  2/100 (2.00%)  2 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumothorax  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pneumothorax spontaneous  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Pulmonary embolism  1  3/100 (3.00%)  3 0/15 (0.00%)  0 0/96 (0.00%)  0
Pulmonary oedema  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Rales  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Respiratory acidosis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Respiratory disorder  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Respiratory failure  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Respiratory tract congestion  1  1/100 (1.00%)  2 0/15 (0.00%)  0 0/96 (0.00%)  0
Tachypnoea  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Blister  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Decubitus ulcer  1  4/100 (4.00%)  5 1/15 (6.67%)  1 1/96 (1.04%)  1
Dermatitis  1  0/100 (0.00%)  0 1/15 (6.67%)  1 1/96 (1.04%)  1
Dermatitis diaper  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Dry skin  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Eczema  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Erythema  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Generalised erythema  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Pruritus  1  0/100 (0.00%)  0 1/15 (6.67%)  1 0/96 (0.00%)  0
Pruritus generalised  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Purpura  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Rash  1  3/100 (3.00%)  3 0/15 (0.00%)  0 1/96 (1.04%)  1
Rash maculo-papular  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Rash papular  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Rosacea  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Seborrhoeic dermatitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 2/96 (2.08%)  2
Skin lesion  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Skin ulcer  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Vascular disorders       
Deep vein thrombosis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Haemodynamic instability  1  1/100 (1.00%)  3 1/15 (6.67%)  1 0/96 (0.00%)  0
Hot flush  1  0/100 (0.00%)  0 0/15 (0.00%)  0 1/96 (1.04%)  1
Hypertension  1  8/100 (8.00%)  8 1/15 (6.67%)  1 7/96 (7.29%)  7
Hypotension  1  2/100 (2.00%)  3 1/15 (6.67%)  2 7/96 (7.29%)  10
Jugular vein thrombosis  1  0/100 (0.00%)  0 0/15 (0.00%)  0 2/96 (2.08%)  2
Peripheral venous disease  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Phlebitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 1/96 (1.04%)  1
Shock  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Thrombophlebitis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
Venous thrombosis  1  1/100 (1.00%)  1 0/15 (0.00%)  0 0/96 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Medimmune has 60 days to review results communications prior to public release and may delete information that compromises on-going 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hasan S. Jafri
Organization: MedImmune, LLC
Phone: 301-398-4431
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02296320    
Other Study ID Numbers: CD-ID-MEDI4893-1139
First Submitted: October 30, 2014
First Posted: November 20, 2014
Results First Submitted: October 1, 2019
Results First Posted: October 25, 2019
Last Update Posted: December 23, 2019