EVADE: Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02696902
• Collaborator: INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET (Other), Antibacterial Resistance Leadership Group (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 188
• Locations: 78
• Arms: 3
• Actual Duration (Months): 44.3
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

Condition or Disease	Intervention/Treatment	Phase
Pseudomonas Aeruginosa	Drug: MEDI3902; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
• Actual Study Start Date: Mar 25, 2016
• Actual Primary Completion Date: Dec 4, 2019
• Actual Study Completion Date: Dec 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MEDI3902 500 mg Participants will receive a single intravenous (IV) dose of 500 mg MEDI3902.	Drug: MEDI3902; Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.
Placebo Comparator: Placebo Participants will receive a single IV dose of placebo matched to MEDI3902.	Other: Placebo; Participants will receive a single IV dose of placebo matched to MEDI3902.
Experimental: MEDI3902 1500 mg Participants will receive a single IV dose of 1500 mg MEDI3902.	Drug: MEDI3902; Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa [Day 1 through Day 22]

   Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.

2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Day 1 through Day 50]

   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.

3. Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) [Day 1 through Day 50]

   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.

4. Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) [Day 1 through Day 50]

   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.

Secondary Outcome Measures

1. Maximum Observed Concentration (Cmax) of MEDI3902 [Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50]

   The Cmax of MEDI3902 is reported.

2. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902 [Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50]

   The AUC0-inf of MEDI3902 is reported.

3. Clearance (CL) of MEDI3902 [Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50]

   The CL of MEDI3902 from body after intrevanous administration of single dose is reported.

4. Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose [Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22]

   Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.

5. Terminal Elimination Half-life (t1/2) of MEDI3902 [Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50]

   The t1/2 of MEDI3902 is reported.

6. Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment [Day 1 (predose), Day 15, Day 29, Day 50]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Colonized with P aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia.

Exclusion Criteria:

P aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified Anti-P aeruginosa antibiotics, moribund participants.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Englewood	Colorado	United States	80113
2	Research Site	Gainesville	Florida	United States	32608
3	Research Site	Atlanta	Georgia	United States	30322
4	Research Site	Augusta	Georgia	United States	30912
5	Research Site	Annapolis	Maryland	United States	21401
6	Research Site	Boston	Massachusetts	United States	02111
7	Research Site	Detroit	Michigan	United States	48202
8	Research Site	Cincinnati	Ohio	United States	45267
9	Research Site	Innsbruck		Austria	6020
10	Research Site	Wien		Austria	1080
11	Research Site	Bruges		Belgium	8000
12	Research Site	Brussels		Belgium	1020
13	Research Site	Brussels		Belgium	1090
14	Research Site	Genk		Belgium	3600
15	Research Site	Gent		Belgium	9000
16	Research Site	Haine-Saint-Paul		Belgium	7100
17	Research Site	Ottignies		Belgium	1340
18	Research Site	Slavonski Brod		Croatia	35000
19	Research Site	Brno		Czechia	656 91
20	Research Site	Decin		Czechia	405 99
21	Research Site	Kolin		Czechia	280 02
22	Research Site	Kyjov		Czechia	697 01
23	Research Site	Teplice		Czechia	415 29
24	Research Site	Argenteuil		France	95107
25	Research Site	Clermont-ferrand		France	63003
26	Research Site	Garches		France	92380
27	Research Site	La Tronche		France	38700
28	Research Site	Le Kremlin Bicetre		France	94275
29	Research Site	Le Plessis Robinson		France	92350
30	Research Site	Lille Cedex		France	59037
31	Research Site	Limoges		France	87042
32	Research Site	Montpellier Cedex 5		France	34295
33	Research Site	Nancy		France	54035
34	Research Site	Paris Cedex 14		France	75014
35	Research Site	Paris		France	75015
36	Research Site	Paris		France	75651
37	Research Site	Paris		France	75679
38	Research Site	Pierre Benite		France	69495
39	Research Site	Strasbourg		France	67090
40	Research Site	Tours		France	37000
41	Research Site	Athens		Greece	10676
42	Research Site	Athens		Greece	11521
43	Research Site	Athens		Greece	11527
44	Research Site	Athens		Greece	14233
45	Research Site	Athens		Greece	14564
46	Research Site	Larissa		Greece	41110
47	Research Site	Larissa		Greece	41221
48	Research Site	Thessaloniki		Greece	54634
49	Research Site	Budapest		Hungary	1121
50	Research Site	Kistarcsa		Hungary	02143
51	Research Site	Vác		Hungary	2600
52	Research Site	Dublin		Ireland	6
53	Research Site	Jerusalem		Israel	91120
54	Research Site	Petach-Tikva		Israel	4941492
55	Research Site	Ramat Gan		Israel	5265601
56	Research Site	Tel Aviv		Israel	6423906
57	Research Site	Almada		Portugal	2805-267
58	Research Site	Lisboa		Portugal	1449-005
59	Research Site	Lisboa		Portugal	1649-035
60	Research Site	Viana do Castelo		Portugal	4904-858
61	Research Site	Barcelona		Spain	08025
62	Research Site	Barcelona		Spain	08036
63	Research Site	Cordoba		Spain	14004
64	Research Site	Getafe		Spain	28905
65	Research Site	Madrid		Spain	28040
66	Research Site	Oviedo		Spain	33011
67	Research Site	San Sebastián de los Reyes		Spain	28702
68	Research Site	Santander		Spain	39008
69	Research Site	Tarragona		Spain	43007
70	Research Site	Terrassa		Spain	08221
71	Research Site	Valencia		Spain	46026
72	Research Site	Valladolid		Spain	47012
73	Research Site	Ankara		Turkey	6100
74	Research Site	Istanbul		Turkey	34890
75	Research Site	Trabzon		Turkey	61080
76	Research Site	Edgbaston		United Kingdom	B15 2GW
77	Research Site	London		United Kingdom	SE1 7EH
78	Research Site	London		United Kingdom	SE5 9RS

Sponsors and Collaborators

• MedImmune LLC
• INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET
• Antibacterial Resistance Leadership Group
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Director: MedImmune LLC, MedImmune LLC

Study Documents (Full-Text)

• Study Protocol - Jun 6, 2018
• Statistical Analysis Plan - Feb 17, 2020

More Information

Additional Information:

• Redacted CSP for CT.gov results
• D5470C00004 Redacted SAP for CT.gov results

Publications

None provided.

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT02696902
• Other Study ID Numbers: D5470C00004
• First Posted: Mar 2, 2016
• Last Update Posted: Feb 4, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by MedImmune LLC: Pseudomonas aeruginosa, Pneumonia
• Additional relevant MeSH terms: Pneumonia; Pseudomonas Infections; Healthcare-Associated Pneumonia

Study Results

Participant Flow

Recruitment Details	A total of 188 participants were assigned to the study treatment groups. Out of 188 participants, 4 participants did not receive the study treatment.

Arm/Group Title	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Period Title: Overall Study
STARTED	85	16	87
Treated	83	16	85
Intent-to-treat (ITT) Population	85	16	87
As-treated Population	83	16	85
Modified Intent-to-treat (mITT) Population	83	16	85
COMPLETED	63	12	59
NOT COMPLETED	22	4	28

Baseline Characteristics

Arm/Group Title	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg	Total
Arm/Group Description	Of the 85 participants, 83 participants received single intravenous (IV) dose of placebo matched to MEDI3902.	Participants received single IV dose of 500 mg MEDI3902.	Of the 87 participants, 85 participants received single IV dose of 1500 mg MEDI3902.	Total of all reporting groups
Overall Participants	85	16	87	188
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.4 (13.0)	62.7 (9.3)	60.6 (15.1)	62.5 (13.8)
Sex: Female, Male (Count of Participants)
Female	22 25.9%	6 37.5%	32 36.8%	60 31.9%
Male	63 74.1%	10 62.5%	55 63.2%	128 68.1%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 1.2%	0 0%	0 0%	1 0.5%
Black or African American	4 4.7%	0 0%	2 2.3%	6 3.2%
Native Hawaiian or Other Pacific Islander	1 1.2%	0 0%	0 0%	1 0.5%
White	77 90.6%	16 100%	83 95.4%	176 93.6%
Other	2 2.4%	0 0%	2 2.3%	4 2.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa
Description	Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported.
Time Frame	Day 1 through Day 22

Outcome Measure Data

Analysis Population Description

The modified intent to treat (mITT) population included all randomized and treated participants, grouped according to assigned treatment.

Arm/Group Title	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	83	16	85
Number [Percentage of participants]	18.1 21.3%	12.5 78.1%	22.4 25.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, MEDI3902 1500 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.491
	Comments
	Method	Poisson regression with robust variance
	Comments
Method of Estimation	Estimation Parameter	Relative risk reduction
	Estimated Value	-23.7
	Confidence Interval	(2-Sided) 80%; -83.8 to 16.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description	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.
Time Frame	Day 1 through Day 50

Outcome Measure Data

Analysis Population Description

The As-treated population is all treated participants, grouped according to actual treatment received.

Arm/Group Title	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	83	16	85
Count of Participants [Participants]	81 95.3%	15 93.8%	84 96.6%

3. Primary Outcome

Title	Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Description	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.
Time Frame	Day 1 through Day 50

Outcome Measure Data

Analysis Population Description

The As-treated population is all treated participants, grouped according to actual treatment received.

Arm/Group Title	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	83	16	85
Count of Participants [Participants]	35 41.2%	4 25%	38 43.7%

4. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
Description	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.
Time Frame	Day 1 through Day 50

Outcome Measure Data

Analysis Population Description

The As-treated population is all treated participants, grouped according to actual treatment received.

Arm/Group Title	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	83	16	85
Count of Participants [Participants]	1 1.2%	0 0%	2 2.3%

5. Secondary Outcome

Title	Maximum Observed Concentration (Cmax) of MEDI3902
Description	The Cmax of MEDI3902 is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	16	84
Mean (Standard Deviation) [mcg/mL]	87.6 (23.9)	299 (94.1)

6. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902
Description	The AUC0-inf of MEDI3902 is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	16	81
Mean (Standard Deviation) [day*mcg/mL]	440 (135)	1510 (675)

7. Secondary Outcome

Title	Clearance (CL) of MEDI3902
Description	The CL of MEDI3902 from body after intrevanous administration of single dose is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	16	81
Mean (Standard Deviation) [L/day]	1.31 (0.638)	1.27 (0.86)

8. Secondary Outcome

Title	Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose
Description	Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	16	84
Number [Percentage of participants]	50 58.8%	80.6 503.8%

9. Secondary Outcome

Title	Terminal Elimination Half-life (t1/2) of MEDI3902
Description	The t1/2 of MEDI3902 is reported.
Time Frame	Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	16	81
Mean (Standard Deviation) [day]	6.56 (4.03)	5.65 (2.69)

10. Secondary Outcome

Title	Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 Treatment
Description	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.
Time Frame	Day 1 (predose), Day 15, Day 29, Day 50

Outcome Measure Data

Analysis Population Description

The As-treated population is all treated participants, grouped according to actual treatment received.

Arm/Group Title	Placebo	MEDI3902 500 mg	MEDI3902 1500 mg
Arm/Group Description	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.	Participants received single IV dose of 500 mg MEDI3902.	Participants received single IV dose of 1500 mg MEDI3902.
Measure Participants	83	16	85
Positive at baseline and post-baseline	3 3.5%	2 12.5%	1 1.1%
Persistent positive	4 4.7%	2 12.5%	4 4.6%
Transient positive	2 2.4%	2 12.5%	8 9.2%

Adverse Events

Time Frame	Day 1 through Day 50
Arm/Group Title	Placebo		MEDI3902 500 mg		MEDI3902 1500 mg
Arm/Group Description	Participants received single intravenous (IV) dose of placebo matched to MEDI3902.		Participants received single IV dose of 500 mg MEDI3902.		Participants received single IV dose of 1500 mg MEDI3902.
All Cause Mortality
	Placebo		MEDI3902 500 mg		MEDI3902 1500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/83 (22.9%)		3/16 (18.8%)		24/85 (28.2%)
Serious Adverse Events
	Placebo		MEDI3902 500 mg		MEDI3902 1500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/83 (42.2%)		4/16 (25%)		38/85 (44.7%)
Cardiac disorders
Bradycardia	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Cardiac arrest	5/83 (6%)	5	1/16 (6.3%)	1	1/85 (1.2%)	1
Cardiac failure	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Cardiogenic shock	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Myocarditis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pulseless electrical activity	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Sinus node dysfunction	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Ear and labyrinth disorders
Deafness	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Gastrointestinal disorders
Duodenal ulcer	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Intestinal haemorrhage	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pancreatitis	0/83 (0%)	0	1/16 (6.3%)	1	1/85 (1.2%)	1
General disorders
Chest pain	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Death	0/83 (0%)	0	1/16 (6.3%)	1	1/85 (1.2%)	1
General physical health deterioration	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Multiple organ dysfunction syndrome	3/83 (3.6%)	3	0/16 (0%)	0	2/85 (2.4%)	2
Pyrexia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Infections and infestations
Acinetobacter bacteraemia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Bacterial sepsis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Biliary tract infection	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Brain abscess	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Bronchitis bacterial	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Burkholderia cepacia complex infection	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Candida sepsis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Endocarditis enterococcal	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Escherichia sepsis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Klebsiella bacteraemia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Klebsiella sepsis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Peritonitis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pneumonia pseudomonal	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pseudomonal bacteraemia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pseudomonal sepsis	4/83 (4.8%)	4	0/16 (0%)	0	1/85 (1.2%)	1
Septic shock	3/83 (3.6%)	3	0/16 (0%)	0	3/85 (3.5%)	3
Staphylococcal sepsis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Injury, poisoning and procedural complications
Post procedural haemorrhage	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Weaning failure	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Investigations
Oxygen saturation decreased	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Musculoskeletal and connective tissue disorders
Spinal pain	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Nervous system disorders
Brain injury	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Cerebral infarction	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Coma	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Haemorrhagic stroke	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Ischaemic stroke	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Seizure	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Product Issues
Device occlusion	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Renal and urinary disorders
Acute kidney injury	3/83 (3.6%)	3	0/16 (0%)	0	0/85 (0%)	0
Chronic kidney disease	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Polyuria	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/83 (1.2%)	1	0/16 (0%)	0	4/85 (4.7%)	4
Asphyxia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Aspiration	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Atelectasis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Chronic obstructive pulmonary disease	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Lower respiratory tract congestion	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Mediastinal haemorrhage	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Respiratory arrest	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Respiratory failure	0/83 (0%)	0	0/16 (0%)	0	4/85 (4.7%)	4
Vascular disorders
Shock	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		MEDI3902 500 mg		MEDI3902 1500 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/83 (95.2%)		15/16 (93.8%)		82/85 (96.5%)
Blood and lymphatic system disorders
Anaemia	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Anaemia of chronic disease	4/83 (4.8%)	5	0/16 (0%)	0	4/85 (4.7%)	4
Blood loss anaemia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Haemolytic anaemia	5/83 (6%)	9	0/16 (0%)	0	8/85 (9.4%)	13
Iron deficiency anaemia	7/83 (8.4%)	10	1/16 (6.3%)	1	2/85 (2.4%)	2
Leukocytosis	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Microcytic anaemia	2/83 (2.4%)	2	1/16 (6.3%)	1	0/85 (0%)	0
Normocytic anaemia	0/83 (0%)	0	1/16 (6.3%)	1	1/85 (1.2%)	1
Splenomegaly	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Thrombocytopenia	1/83 (1.2%)	2	0/16 (0%)	0	4/85 (4.7%)	4
Thrombocytosis	0/83 (0%)	0	1/16 (6.3%)	1	1/85 (1.2%)	1
Cardiac disorders
Atrial fibrillation	3/83 (3.6%)	3	2/16 (12.5%)	2	4/85 (4.7%)	7
Atrial tachycardia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Bradycardia	2/83 (2.4%)	2	0/16 (0%)	0	3/85 (3.5%)	5
Cardiac arrest	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Cardiac failure	0/83 (0%)	0	1/16 (6.3%)	1	1/85 (1.2%)	1
Cardiac failure congestive	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Cardiogenic shock	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Coronary artery occlusion	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Cyanosis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Mitral valve stenosis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Sinus bradycardia	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Sinus tachycardia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Supraventricular tachycardia	1/83 (1.2%)	2	0/16 (0%)	0	0/85 (0%)	0
Tachycardia	7/83 (8.4%)	11	0/16 (0%)	0	3/85 (3.5%)	3
Ventricular dysfunction	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Ventricular tachycardia	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Ear and labyrinth disorders
Ear pain	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Excessive cerumen production	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Endocrine disorders
Adrenal insufficiency	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Diabetes insipidus	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Euthyroid sick syndrome	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hyperprolactinaemia	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Hypothyroidism	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Eye disorders
Blindness unilateral	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Dry eye	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Noninfective conjunctivitis	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Ocular hyperaemia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pupils unequal	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Gastrointestinal disorders
Abdominal distension	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Abdominal pain	6/83 (7.2%)	6	2/16 (12.5%)	3	3/85 (3.5%)	6
Abdominal pain upper	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Aerophagia	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Anal incontinence	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Colitis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Constipation	11/83 (13.3%)	13	4/16 (25%)	5	11/85 (12.9%)	11
Diarrhoea	11/83 (13.3%)	16	4/16 (25%)	5	12/85 (14.1%)	14
Dysphagia	2/83 (2.4%)	2	0/16 (0%)	0	6/85 (7.1%)	6
Faecaloma	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Flatulence	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Gastrointestinal hypomotility	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Gastrointestinal motility disorder	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Gastrointestinal oedema	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Gastrooesophageal reflux disease	2/83 (2.4%)	2	1/16 (6.3%)	1	1/85 (1.2%)	1
Ileus	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Ileus paralytic	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Intestinal dilatation	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Lip haemorrhage	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Melaena	3/83 (3.6%)	3	0/16 (0%)	0	2/85 (2.4%)	2
Nausea	3/83 (3.6%)	5	4/16 (25%)	5	1/85 (1.2%)	2
Oesophagopleural fistula	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Oral mucosa haematoma	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pancreatic failure	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Pancreatic necrosis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pancreatitis	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Perianal erythema	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Rectal haemorrhage	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	2
Salivary hypersecretion	1/83 (1.2%)	1	1/16 (6.3%)	1	2/85 (2.4%)	2
Vomiting	3/83 (3.6%)	5	2/16 (12.5%)	4	4/85 (4.7%)	6
General disorders
Asthenia	2/83 (2.4%)	2	0/16 (0%)	0	1/85 (1.2%)	1
Catheter site inflammation	2/83 (2.4%)	3	0/16 (0%)	0	0/85 (0%)	0
Catheter site pain	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Chills	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Complication associated with device	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Generalised oedema	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Granuloma	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hyperthermia	2/83 (2.4%)	4	1/16 (6.3%)	1	2/85 (2.4%)	2
Hypothermia	2/83 (2.4%)	3	0/16 (0%)	0	2/85 (2.4%)	3
Localised oedema	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Medical device pain	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Medical device site dermatitis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Medical device site haemorrhage	1/83 (1.2%)	2	0/16 (0%)	0	0/85 (0%)	0
Mucosal ulceration	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Non-cardiac chest pain	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Oedema peripheral	4/83 (4.8%)	4	1/16 (6.3%)	1	3/85 (3.5%)	4
Pain	8/83 (9.6%)	15	0/16 (0%)	0	7/85 (8.2%)	7
Peripheral swelling	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Pyrexia	13/83 (15.7%)	20	1/16 (6.3%)	1	16/85 (18.8%)	20
Swelling	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Thirst	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Hepatobiliary disorders
Cholecystitis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Cholelithiasis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Cholestasis	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Drug-induced liver injury	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hepatocellular injury	2/83 (2.4%)	2	0/16 (0%)	0	2/85 (2.4%)	2
Ischaemic hepatitis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Infections and infestations
Abdominal infection	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Acinetobacter infection	2/83 (2.4%)	2	0/16 (0%)	0	5/85 (5.9%)	5
Anal fungal infection	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Bacteraemia	4/83 (4.8%)	4	0/16 (0%)	0	4/85 (4.7%)	5
Bacterial abdominal infection	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Bacterial disease carrier	1/83 (1.2%)	2	0/16 (0%)	0	3/85 (3.5%)	5
Bacterial infection	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Bacterial sepsis	0/83 (0%)	0	0/16 (0%)	0	4/85 (4.7%)	4
Bacteriuria	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Bronchitis bacterial	2/83 (2.4%)	2	0/16 (0%)	0	2/85 (2.4%)	2
Candida infection	2/83 (2.4%)	2	0/16 (0%)	0	2/85 (2.4%)	2
Candiduria	2/83 (2.4%)	2	0/16 (0%)	0	1/85 (1.2%)	1
Cellulitis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Citrobacter bacteraemia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Clostridium difficile colitis	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	3
Conjunctivitis	1/83 (1.2%)	3	1/16 (6.3%)	1	0/85 (0%)	0
Cystitis klebsiella	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Empyema	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Endocarditis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Enterobacter bacteraemia	2/83 (2.4%)	2	0/16 (0%)	0	2/85 (2.4%)	2
Enterobacter pneumonia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Enterococcal bacteraemia	0/83 (0%)	0	1/16 (6.3%)	1	2/85 (2.4%)	2
Enterococcal infection	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	2
Enterococcal sepsis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Escherichia bacteraemia	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Escherichia urinary tract infection	5/83 (6%)	5	1/16 (6.3%)	2	3/85 (3.5%)	4
Eye infection	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Fungaemia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Fungal skin infection	2/83 (2.4%)	2	0/16 (0%)	0	1/85 (1.2%)	1
Genital infection female	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Haematoma infection	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Herpes virus infection	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Herpes zoster	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Infectious pleural effusion	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Influenza	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Klebsiella bacteraemia	1/83 (1.2%)	1	0/16 (0%)	0	3/85 (3.5%)	3
Klebsiella infection	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Klebsiella sepsis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Lower respiratory tract infection bacterial	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Lung infection pseudomonal	2/83 (2.4%)	5	0/16 (0%)	0	1/85 (1.2%)	1
Morganella infection	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Oral candidiasis	1/83 (1.2%)	1	0/16 (0%)	0	3/85 (3.5%)	3
Oral fungal infection	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Oral herpes	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Oropharyngeal candidiasis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pneumonia	1/83 (1.2%)	1	1/16 (6.3%)	1	3/85 (3.5%)	3
Pneumonia acinetobacter	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Pneumonia bacterial	12/83 (14.5%)	13	2/16 (12.5%)	2	4/85 (4.7%)	5
Pneumonia escherichia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pneumonia proteus	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pneumonia pseudomonal	12/83 (14.5%)	13	1/16 (6.3%)	1	13/85 (15.3%)	15
Pneumonia staphylococcal	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Proteus infection	4/83 (4.8%)	4	1/16 (6.3%)	2	1/85 (1.2%)	1
Pseudomonal bacteraemia	6/83 (7.2%)	6	0/16 (0%)	0	6/85 (7.1%)	6
Pseudomonal sepsis	5/83 (6%)	6	0/16 (0%)	0	0/85 (0%)	0
Pseudomonas bronchitis	5/83 (6%)	5	4/16 (25%)	4	4/85 (4.7%)	4
Pseudomonas infection	4/83 (4.8%)	4	0/16 (0%)	0	4/85 (4.7%)	4
Pyuria	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Septic shock	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Serratia bacteraemia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Serratia sepsis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Staphylococcal bacteraemia	2/83 (2.4%)	2	1/16 (6.3%)	1	4/85 (4.7%)	4
Staphylococcal infection	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Staphylococcal sepsis	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Stenotrophomonas infection	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Stoma site infection	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Systemic candida	3/83 (3.6%)	3	0/16 (0%)	0	1/85 (1.2%)	1
Tracheobronchitis	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Upper respiratory tract infection	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Urinary tract infection	1/83 (1.2%)	1	1/16 (6.3%)	2	3/85 (3.5%)	3
Urinary tract infection bacterial	3/83 (3.6%)	3	0/16 (0%)	0	3/85 (3.5%)	3
Urinary tract infection pseudomonal	5/83 (6%)	6	0/16 (0%)	0	4/85 (4.7%)	4
Urinary tract infection staphylococcal	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Varicella zoster virus infection	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Vulvovaginal candidiasis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Vulvovaginal mycotic infection	1/83 (1.2%)	1	1/16 (6.3%)	1	0/85 (0%)	0
Injury, poisoning and procedural complications
Dialysis related complication	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Endotracheal intubation complication	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Eschar	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Fall	0/83 (0%)	0	1/16 (6.3%)	2	0/85 (0%)	0
Flail chest	1/83 (1.2%)	2	0/16 (0%)	0	0/85 (0%)	0
Gastrostomy tube site complication	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Haemodilution	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Inflammation of wound	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Infusion related reaction	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Joint dislocation	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Overdose	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Palate injury	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Post procedural haematuria	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Post procedural inflammation	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Postoperative hypotension	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Postoperative wound complication	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Procedural haemorrhage	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Procedural hypotension	3/83 (3.6%)	3	0/16 (0%)	0	1/85 (1.2%)	1
Procedural pain	0/83 (0%)	0	1/16 (6.3%)	1	3/85 (3.5%)	3
Scar	2/83 (2.4%)	2	0/16 (0%)	0	1/85 (1.2%)	1
Scratch	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Seroma	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Skin laceration	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Stoma site erythema	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Tracheal haemorrhage	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Vascular pseudoaneurysm	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	2
Weaning failure	2/83 (2.4%)	2	0/16 (0%)	0	2/85 (2.4%)	2
Wound necrosis	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Wound secretion	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Investigations
Alanine aminotransferase increased	4/83 (4.8%)	4	0/16 (0%)	0	0/85 (0%)	0
Aspartate aminotransferase increased	3/83 (3.6%)	3	0/16 (0%)	0	0/85 (0%)	0
Blood albumin decreased	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Blood glucose increased	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Blood magnesium decreased	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Blood potassium decreased	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Blood sodium decreased	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Blood urea increased	0/83 (0%)	0	0/16 (0%)	0	3/85 (3.5%)	3
C-reactive protein increased	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Electrocardiogram qt prolonged	0/83 (0%)	0	1/16 (6.3%)	1	1/85 (1.2%)	1
Inflammatory marker increased	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Oxygen saturation abnormal	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Oxygen saturation decreased	3/83 (3.6%)	9	0/16 (0%)	0	3/85 (3.5%)	10
Pco2 increased	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Po2 decreased	1/83 (1.2%)	3	0/16 (0%)	0	1/85 (1.2%)	5
Transaminases increased	1/83 (1.2%)	1	1/16 (6.3%)	1	1/85 (1.2%)	1
Urine output decreased	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
White blood cell count increased	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Metabolism and nutrition disorders
Acidosis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	3
Alkalosis	2/83 (2.4%)	2	0/16 (0%)	0	1/85 (1.2%)	6
Decreased appetite	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Dehydration	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Fluid overload	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Fluid retention	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Hyperammonaemia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Hypercalcaemia	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Hypercholesterolaemia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Hyperglycaemia	1/83 (1.2%)	1	0/16 (0%)	0	4/85 (4.7%)	5
Hyperkalaemia	2/83 (2.4%)	2	0/16 (0%)	0	3/85 (3.5%)	4
Hypernatraemia	3/83 (3.6%)	3	1/16 (6.3%)	1	5/85 (5.9%)	5
Hyperphosphataemia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hypoalbuminaemia	4/83 (4.8%)	4	0/16 (0%)	0	3/85 (3.5%)	3
Hypocalcaemia	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Hypoglycaemia	0/83 (0%)	0	1/16 (6.3%)	1	2/85 (2.4%)	2
Hypokalaemia	9/83 (10.8%)	12	1/16 (6.3%)	1	15/85 (17.6%)	25
Hypomagnesaemia	1/83 (1.2%)	1	0/16 (0%)	0	3/85 (3.5%)	3
Hyponatraemia	3/83 (3.6%)	3	0/16 (0%)	0	2/85 (2.4%)	2
Hypophosphataemia	0/83 (0%)	0	0/16 (0%)	0	4/85 (4.7%)	4
Hypoproteinaemia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hypovolaemia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Metabolic acidosis	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Metabolic alkalosis	3/83 (3.6%)	3	0/16 (0%)	0	4/85 (4.7%)	5
Vitamin k deficiency	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Back pain	0/83 (0%)	0	1/16 (6.3%)	1	2/85 (2.4%)	2
Bone disorder	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Coccydynia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Exposed bone in jaw	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Muscle spasms	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	3
Musculoskeletal chest pain	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Musculoskeletal pain	3/83 (3.6%)	4	3/16 (18.8%)	3	2/85 (2.4%)	2
Musculoskeletal stiffness	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Myopathy	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Neck pain	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pain in extremity	3/83 (3.6%)	3	1/16 (6.3%)	1	3/85 (3.5%)	3
Nervous system disorders
Aphasia	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Complex regional pain syndrome	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Epilepsy	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Extrapyramidal disorder	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Frontotemporal dementia	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Headache	2/83 (2.4%)	3	0/16 (0%)	0	4/85 (4.7%)	7
Hydrocephalus	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hypoxic-ischaemic encephalopathy	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Loss of consciousness	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Metabolic encephalopathy	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Motor dysfunction	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Myoclonus	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Neuropathy peripheral	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Paresis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Parkinsonism	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Peripheral motor neuropathy	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Peripheral sensorimotor neuropathy	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Peroneal nerve palsy	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Post cardiac arrest syndrome	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Psychomotor hyperactivity	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Seizure	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Somnolence	2/83 (2.4%)	2	0/16 (0%)	0	2/85 (2.4%)	2
Syncope	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Tremor	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Product Issues
Stent malfunction	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Thrombosis in device	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Psychiatric disorders
Adjustment disorder with depressed mood	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Agitation	3/83 (3.6%)	3	1/16 (6.3%)	1	3/85 (3.5%)	3
Anxiety	4/83 (4.8%)	5	3/16 (18.8%)	3	2/85 (2.4%)	2
Apathy	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Compulsive lip biting	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Delirium	1/83 (1.2%)	1	0/16 (0%)	0	5/85 (5.9%)	5
Depression	2/83 (2.4%)	2	0/16 (0%)	0	3/85 (3.5%)	3
Depressive symptom	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Disinhibition	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Disorientation	1/83 (1.2%)	1	1/16 (6.3%)	1	1/85 (1.2%)	1
Initial insomnia	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Insomnia	9/83 (10.8%)	10	0/16 (0%)	0	7/85 (8.2%)	7
Intensive care unit delirium	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Nervousness	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Restlessness	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Renal and urinary disorders
Acute kidney injury	3/83 (3.6%)	3	0/16 (0%)	0	1/85 (1.2%)	1
Anuria	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Chronic kidney disease	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Haematuria	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Haemorrhage urinary tract	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Nephrolithiasis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Oliguria	5/83 (6%)	6	1/16 (6.3%)	1	5/85 (5.9%)	5
Polyuria	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Proteinuria	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Renal cyst	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Renal failure	3/83 (3.6%)	3	0/16 (0%)	0	5/85 (5.9%)	5
Renal impairment	1/83 (1.2%)	1	1/16 (6.3%)	1	2/85 (2.4%)	2
Tubulointerstitial nephritis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Urinary retention	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Urinary tract disorder	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Urine abnormality	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Vesical fistula	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Reproductive system and breast disorders
Cervical cyst	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Genital pain	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Oedema genital	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Penile discharge	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Penile oedema	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Prostatitis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pruritus genital	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Vulval disorder	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Acute respiratory failure	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Apnoea	1/83 (1.2%)	2	0/16 (0%)	0	0/85 (0%)	0
Aspiration	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Atelectasis	4/83 (4.8%)	5	1/16 (6.3%)	1	4/85 (4.7%)	4
Bronchial haemorrhage	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Bronchial obstruction	2/83 (2.4%)	3	0/16 (0%)	0	0/85 (0%)	0
Bronchial secretion retention	2/83 (2.4%)	2	0/16 (0%)	0	1/85 (1.2%)	1
Bronchiectasis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Bronchospasm	2/83 (2.4%)	2	1/16 (6.3%)	1	2/85 (2.4%)	2
Chronic respiratory failure	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Chylothorax	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Cough	2/83 (2.4%)	2	0/16 (0%)	0	1/85 (1.2%)	2
Dyspnoea	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Haemoptysis	2/83 (2.4%)	2	0/16 (0%)	0	0/85 (0%)	0
Haemothorax	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Hiccups	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Hypercapnia	2/83 (2.4%)	2	0/16 (0%)	0	5/85 (5.9%)	8
Hyperventilation	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Hypopnoea	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Hypoventilation	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hypoxia	1/83 (1.2%)	2	0/16 (0%)	0	2/85 (2.4%)	2
Increased bronchial secretion	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Increased viscosity of bronchial secretion	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Interstitial lung disease	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Laryngeal oedema	3/83 (3.6%)	3	0/16 (0%)	0	2/85 (2.4%)	2
Lung infiltration	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Nasal congestion	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Oropharyngeal pain	0/83 (0%)	0	2/16 (12.5%)	2	1/85 (1.2%)	1
Pleural disorder	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pleural effusion	2/83 (2.4%)	2	3/16 (18.8%)	3	3/85 (3.5%)	4
Pneumonitis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Pneumothorax	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pulmonary congestion	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pulmonary embolism	1/83 (1.2%)	1	0/16 (0%)	0	2/85 (2.4%)	2
Pulmonary fistula	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Pulmonary oedema	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	5
Respiratory acidosis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Respiratory distress	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Respiratory failure	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Respiratory fatigue	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Rhinorrhoea	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Rhonchi	2/83 (2.4%)	2	0/16 (0%)	0	1/85 (1.2%)	1
Sleep apnoea syndrome	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Sputum retention	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Tachypnoea	2/83 (2.4%)	3	1/16 (6.3%)	1	3/85 (3.5%)	3
Throat irritation	0/83 (0%)	0	1/16 (6.3%)	1	0/85 (0%)	0
Wheezing	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Skin and subcutaneous tissue disorders
Blister	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Decubitus ulcer	6/83 (7.2%)	6	0/16 (0%)	0	5/85 (5.9%)	6
Dermatitis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Dry skin	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Erythema	3/83 (3.6%)	5	0/16 (0%)	0	2/85 (2.4%)	2
Generalised erythema	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hyperhidrosis	0/83 (0%)	0	1/16 (6.3%)	1	3/85 (3.5%)	5
Rash	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Rash erythematous	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Rash maculo-papular	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Rash papular	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Rash pruritic	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Scab	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	2
Skin irritation	0/83 (0%)	0	0/16 (0%)	0	2/85 (2.4%)	2
Skin ulcer	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Skin ulcer haemorrhage	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Stasis dermatitis	1/83 (1.2%)	1	1/16 (6.3%)	1	0/85 (0%)	0
Subcutaneous emphysema	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Swelling face	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Vascular disorders
Artery dissection	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Deep vein thrombosis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Extremity necrosis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Haemodynamic instability	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hypertension	7/83 (8.4%)	9	3/16 (18.8%)	5	3/85 (3.5%)	6
Hypoperfusion	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Hypotension	16/83 (19.3%)	21	1/16 (6.3%)	1	23/85 (27.1%)	29
Jugular vein thrombosis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Orthostatic hypotension	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Peripheral coldness	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Phlebitis	1/83 (1.2%)	1	0/16 (0%)	0	1/85 (1.2%)	1
Subclavian vein thrombosis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Thrombosis	1/83 (1.2%)	1	0/16 (0%)	0	0/85 (0%)	0
Vein disorder	1/83 (1.2%)	1	1/16 (6.3%)	1	0/85 (0%)	0
Vena cava thrombosis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1
Venous thrombosis	0/83 (0%)	0	0/16 (0%)	0	1/85 (1.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.