Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
Official Title
A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL)
Acronym
IMPAHCT-FUL
Organization
Aerovate TherapeuticsINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Results from the parent study (IMPAHCT) demonstrated that while inhaled imatinib was well tolerated, it did not prove to be efficacious at any of the doses of AV-101 evaluated in the study.
Expanded Access Info
No
Start Date
Nov 2, 2022Actual
Primary Completion Date
Aug 8, 2024Actual
Completion Date
Aug 8, 2024Actual
First Submitted Date
Sep 15, 2022
First Submission Date that Met QC Criteria
Sep 23, 2022
First Posted Date
Sep 28, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Sep 6, 2024
Results First Submitted that Met QC Criteria
Oct 9, 2024
Results First Posted Date
Oct 10, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 9, 2024
Last Update Posted Date
Oct 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Aerovate TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (AV-101-002, NCT#05036135) were offered the opportunity to continue into this LTE study. Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study.
Detailed Description
Not provided
Conditions Module
Conditions
Pulmonary Arterial Hypertension
Keywords
Pulmonary Arterial Hypertension
Lungs
Pulmonary
PAH
AV-101
imatinib
IMPAHCT
IMPAHCT-FUL
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
186Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo Crossover AV-101 10 mg
Experimental
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.
Drug: AV-101
Placebo Crossover AV-101 35 mg
Experimental
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
Drug: AV-101
Placebo Crossover AV-101 70 mg
Experimental
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Drug: AV-101
Continuing AV-101 10 mg
Experimental
Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
Drug: AV-101
Continuing AV-101 35 mg
Experimental
Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AV-101
Drug
AV-101 (imatinib) administered via dry powder inhalation
Continuing AV-101 10 mg
Continuing AV-101 35 mg
Continuing AV-101 70 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
From date of first dose to 30 days after date of last dose (up to approximately 21 months)
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
To be eligible, a participant is required to be or have:
Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.
Key Exclusion Criteria:
Subjects meeting any of the following criteria:
The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons.
Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arizona Pulmonary Specialist. LTD.
Phoenix
Arizona
85012
United States
University of Arizona, Department of Medicine
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Crossover AV-101 10 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo
90127
Italy
Fondazione IRCCS Policlinico San Matteo
Pavia
27100
Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
Rome
137
Italy
Pauls Stradins Clinical University Hospital
Riga
1002
Latvia
CICUM San Miguel
Guadalajara
Jalisco
44160
Mexico
Unidad de Investigacion Clinica en Medicina S.C.
Monterrey
Nuevo León
64718
Mexico
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow
31-202
Poland
Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi
Lodz
91-347
Poland
Szpital Kliniczny Przemienienia Pańskiego UM im. Marcinkowskiego
Poznan
61-848
Poland
Hospital Garcia de Orta, EPE
Almada
2805-267
Portugal
Hospital Pulido Valente
Lisbon
1769-001
Portugal
National University Hospital
Singapore
119074
Singapore
Tan Tock Seng Hospital
Singapore
308433
Singapore
Center of Chest Disease Johannesburg
Johannesburg
2193
South Africa
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Hosp. Universitario Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria
35010
Spain
Hospital 12 de Octubre
Madrid
28014
Spain
Hospital Universitario Virgen de la Victoria
Málaga
29071
Spain
Hospital universtario de Salamanca
Salamanca
37007
Spain
Hosp. Universitario Marques de Valdecilla
Santander
39003
Spain
Hospital Universitario de Toledo
Toledo
45007
Spain
Imperial College Healthcare NHS Trust
London
W12 0HS
United Kingdom
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
FG002
Placebo Crossover AV-101 70 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
FG003
Continuing AV-101 10 mg
Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
FG004
Continuing AV-101 35 mg
Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
FG005
Continuing AV-101 70 mg
Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
FG00018 subjects
FG00118 subjects
FG00216 subjects
FG00345 subjects
FG00448 subjects
FG00541 subjects
Received at Least 1 Dose of Study Drug
FG00018 subjects
FG00118 subjects
FG00216 subjects
FG00345 subjects
FG00448 subjects
FG00541 subjects
COMPLETED
"Completed" refers to participants who completed the study
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00018 subjects
FG00118 subjects
FG00216 subjects
FG00345 subjects
FG00448 subjects
FG00541 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0041 subjects
FG0051 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG004
Study terminated by sponsor
FG00017 subjects
FG00117 subjects
FG00214 subjects
FG00340 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Intent-to-treat (ITT) analysis set included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Crossover AV-101 10 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
BG001
Placebo Crossover AV-101 35 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
BG002
Placebo Crossover AV-101 70 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
BG003
Continuing AV-101 10 mg
Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
BG004
Continuing AV-101 35 mg
Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
BG005
Continuing AV-101 70 mg
Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00018
BG00118
BG00216
BG00345
BG00448
BG00541
BG006186
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.1± 12.45
BG00145.9± 13.17
BG00247.9± 11.02
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-emergent Adverse Events
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
The Safety Analysis Set included all participants that received at least one dose of study drug.
Posted
Count of Participants
Participants
From date of first dose to 30 days after date of last dose (up to approximately 21 months)
ID
Title
Description
OG000
Placebo Crossover AV-101 10 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
OG001
Placebo Crossover AV-101 35 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
OG002
Placebo Crossover AV-101 70 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
OG003
Continuing AV-101 10 mg
Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
OG004
Continuing AV-101 35 mg
Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
OG005
Continuing AV-101 70 mg
Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Units
Counts
Participants
OG00018
OG00118
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG0009
OG00111
OG00212
OG003
Time Frame
From date of first dose to date of last dose plus 30 days (up to approximately 21 months)
Description
The safety analysis set included all participants who received at least one dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Crossover AV-101 10 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
0
18
3
18
8
18
EG001
Placebo Crossover AV-101 35 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
0
18
4
18
11
18
EG002
Placebo Crossover AV-101 70 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
0
16
6
16
10
16
EG003
Continuing AV-101 10 mg
Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
2
45
12
45
17
45
EG004
Continuing AV-101 35 mg
Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
1
48
9
48
19
48
EG005
Continuing AV-101 70 mg
Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
1
41
7
41
15
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected18 at risk
EG0020 affected16 at risk
EG0030 affected45 at risk
EG004
Right ventricular failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0021 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected18 at risk
EG0021 affected16 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0021 affected16 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0021 affected16 at risk
EG003
Device related infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Perineal abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected18 at risk
EG0020 affected16 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0021 affected16 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0021 affected16 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Device breakage
Product Issues
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0011 affected18 at risk
EG0020 affected16 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Pulmonary arterial hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Lung hernia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected18 at risk
EG0012 affected18 at risk
EG0021 affected16 at risk
EG0030 affected45 at risk
EG004
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected18 at risk
EG0011 affected18 at risk
EG0020 affected16 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected18 at risk
EG0020 affected16 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected18 at risk
EG0020 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0011 affected18 at risk
EG0021 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0012 affected18 at risk
EG0020 affected16 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0011 affected18 at risk
EG0020 affected16 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected18 at risk
EG0021 affected16 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Bronchitis bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Serratia sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected18 at risk
EG0010 affected18 at risk
EG0020 affected16 at risk
EG003
Transmission of an infectious agent via transplant