Extension Trial of the Long Term Safety of BIBF 1120 in P... | NCT01619085 | Trialant
NCT01619085
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Mar 25, 2022Actual
Enrollment
752Actual
Phase
Phase 3
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Nintedanib
Countries
United States
Australia
Belgium
Canada
Chile
China
Czechia
Finland
France
Germany
Greece
India
Ireland
Israel
Italy
Japan
Mexico
Netherlands
Portugal
Russia
South Korea
Spain
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01619085
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1199.33
Secondary IDs
ID
Type
Description
Link
2011-002766-21
EudraCT Number
Brief Title
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Official Title
An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Feb 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 6, 2012Actual
Primary Completion Date
Jul 5, 2017Actual
Completion Date
Feb 1, 2021Actual
First Submitted Date
Jun 6, 2012
First Submission Date that Met QC Criteria
Jun 12, 2012
First Posted Date
Jun 14, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 2, 2018
Results First Submitted that Met QC Criteria
Jul 2, 2018
Results First Posted Date
Jul 26, 2018Actual
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
Feb 28, 2022
Last Update Posted Date
Mar 25, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.
Detailed Description
Not provided
Conditions Module
Conditions
Idiopathic Pulmonary Fibrosis
Keywords
Not provided
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
752Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
All subjects
Experimental
patient to receive a capsule containing Nintedanib twice a day
Drug: Nintedanib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nintedanib
Drug
Nintedanib twice a day
All subjects
BIBF 1120
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of Adverse Events (AEs)
This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.
From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.
Exclusion criteria:
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper Limit of Normal (ULN) (Patients who completed the parent trial with transaminase values > 1.5 fold ULN but < 3 fold ULN are considered eligible)
Bilirubin > 1.5 fold ULN
Bleeding risk
Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
New major thrombo-embolic events developed after completion of the parent trial.
Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
Usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial.
A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patients' ability to participate in this trial.
Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it until 3 months after end of treatment.
Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019 Jan;7(1):60-68. doi: 10.1016/S2213-2600(18)30339-4. Epub 2018 Sep 14.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Recruitment Details
This was a prospective, open-label extension trial in which patients with Idiopathic pulmonary fibrosis (IPF), who had completed 52 weeks of treatment and the follow-up period in the randomised, double-blind, placebo-controlled parent trials 1199.32(NCT01335464)/.34(NCT01335477) and who needed access to nintedanib outside of the discontinued parent trials 1199.35(NCT01170065)/.187(NCT01979952).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Total (1199.32/.34/.35/.187)
For patients participated in parent trials 1199.32/.34 (both were randomized, placebo-controlled): patients were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. For patients participated in parent trials 1199.35/.187 (1199.35: open label; 1199.187: randomized placebo-control): patients were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 mg bid or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 28, 2017
Nov 29, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Phoenix
Arizona
85006
United States
University of California
Los Angeles
California
90095-1690
United States
University of California
San Francisco
California
94143
United States
Sansum Clinic
Santa Barbara
California
93105
United States
Stanford University Medical Center
Stanford
California
94305
United States
University of California
Torrance
California
90505
United States
Western Connecticut Medical Group
Danbury
Connecticut
06810
United States
Pulmonary Assoc of Stamford
Stamford
Connecticut
06902
United States
Cleveland Clinic
Weston
Florida
33331
United States
Georgia Clinical Research
Austell
Georgia
30106
United States
University of Chicago
Chicago
Illinois
60637
United States
Via Christi Clinic, PA
Wichita
Kansas
67208
United States
Baptist Health Lexington
Lexington
Kentucky
40503
United States
Minnesota Lung Center
Minneapolis
Minnesota
55407
United States
The Lung Research Center, LLC
Chesterfield
Missouri
63017
United States
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Pulmonary and Critical Care Associates
Albany
New York
12205
United States
Jamaica Hospital Medical Center
Jamaica
New York
11418
United States
New York Presbyterian Hospital
New York
New York
10032
United States
University of Cincinnati
Cincinnati
Ohio
45267-0565
United States
ID Clinical Research, LTD
Toledo
Ohio
43608
United States
The Oregon Clinic
Portland
Oregon
97220
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15213
United States
Rhode Island Hospital
Providence
Rhode Island
02903
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232-5735
United States
FDC Seifer PLC Pulmonary
Shelbyville
Tennessee
37160
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75235-8550
United States
DCOL Center for Clinical Research
Longview
Texas
75605
United States
Metroplex Pul and Sleep Ctr
McKinney
Texas
75069-1769
United States
Diagnostics Research Group
San Antonio
Texas
78229
United States
Vermont Lung Center
Colchester
Vermont
05446
United States
Inova Fairfax Hospital
Falls Church
Virginia
22042
United States
Lynchburg Pulmonary Associates
Lynchburg
Virginia
24501
United States
University of Wisconsin
Madison
Wisconsin
53792
United States
Royal Prince Alfred Hospital
Camperdown
New South Wales
2050
Australia
Repatriation General Hospital
Concord
New South Wales
2137
Australia
Frankston Hospital
Frankston
Victoria
3199
Australia
Alfred Hospital
Melbourne
Victoria
3000
Australia
ULB Hopital Erasme
Brussels
1070
Belgium
Brussels - UNIV UZ Brussel
Brussels
1090
Belgium
UZ Leuven
Leuven
3000
Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir
5530
Belgium
QEII Health Sciences Centre
Halifax
Nova Scotia
B3H 3A7
Canada
St. Joseph's Healthcare Hamilton
Hamilton
Ontario
L8N 4A6
Canada
Instituto Nacional del Tórax
Santiago
7500000
Chile
Peking University People's Hospital
Beijing
100044
China
Beijing Friendship Hospital
Beijing
100050
China
Peking Union Medical College Hospital
Beijing
100730
China
Xiangya Hospital, Central South University
Changsha
410008
China
West China Hospital
Chengdu
610042
China
The First Affiliated Hospital of Nanchang University
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen
45239
Germany
Universitätsklinikum Freiburg
Freiburg/Breisgau
79106
Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen
35392
Germany
Universitätsmedizin Greifswald
Greifswald
17475
Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf
22927
Germany
Universitätsklinikum Heidelberg
Heidelberg
69126
Germany
Lungenfachklinik Immenhausen
Immenhausen
34376
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
55131
Germany
Klinikum der Universität München - Campus Großhadern
München
81377
Germany
Universitätsklinikum Münster
Münster
48149
Germany
Athens Hospital of Chest Diseases "Sotiria"
Athens
11527
Greece
University Hospital of Heraklion, University Pulmonology Cl
Heraklion
71100
Greece
General University Hospital of Larissa
Larissa
41110
Greece
Mehta Hospital & Cardiopulmonary Care Centre
Ahmedabad
380054
India
Chest & Maternity Center
Bangalore
560010
India
Asthma Bhawan
Jaipur
302023
India
National Allergy Asthma Bronchitis Institute, Kolkata
Kolkata
700017
India
P.D. Hinduja National Hospital
Mumbai
400016
India
Jahingir Clinical Development Centre
Pune
411001
India
Mater Misericordiae University Hospital
Dublin
7
Ireland
Rabin Medical Center Beilinson
Petah Tikva
49100
Israel
Kaplan Medical Center
Rehovot
76100
Israel
Osp. Clin. SS. Anunziata
Chieti Scalo
56100
Italy
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
Forlì
47100
Italy
Osp. S. Giuseppe Fatebenefratelli
Milan
20123
Italy
Università di Modena e Reggio Emilia
Modena
41100
Italy
A.O. San Gerardo di Monza
Monza
20052
Italy
Università Federico II
Naples
80131
Italy
Università degli Studi Padova
Padova
35128
Italy
Ospedale di Cisanello
Pisa
56100
Italy
Ospedale di Cisanello
Pisa
56124
Italy
Pol. Universitario Tor Vergata
Roma
00133
Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena
53100
Italy
Nagoya University Hospital
Aichi, Nagoya
466-8560
Japan
Tosei General Hospital
Aichi, Seto
489-8642
Japan
Ogaki Municipal Hospital
Gifu, Ogaki
503-0864
Japan
National Hospital Organization Himeji Medical Center
Himeji, Hyogo
670-8520
Japan
Kobe City Medical Center General Hospital
Hyogo, Kobe
650-0047
Japan
Ibarakihigashi National Hospial
Ibaraki, Naka-gun
319-1113
Japan
Toranomon Hospital Kajigaya
Kanagawa, Kawasaki
213-0015
Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama
236-0051
Japan
Tohoku University Hospital
Miyagi, Sendai
980-8574
Japan
Tenri Hospital
Nara, Tenri
632-8552
Japan
Kindai University Hospital
Osaka, Osaka-sayama
589-8511
Japan
Saitama Cardiovascular and Respiratory Center
Saitama, Kumagaya
360-0105
Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, Osaka
591-8555
Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke
329-0498
Japan
Tokushima University Hospital
Tokushima, Tokushima
770-0042
Japan
Tokyo Medical and Dental University
Tokyo, Bunkyo-ku
113-8519
Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku
113-8603
Japan
Fukujuji Hospital
Tokyo, Kiyose
204-0022
Japan
Toranomon Hospital
Tokyo, Minato-ku
105-0001
Japan
The Jikei University Hospital
Tokyo, Minato-ku
105-0003
Japan
Toho University Omori Medical Center
Tokyo, Ota-ku
143-0015
Japan
JR Tokyo General Hospital
Tokyo, Shibuya-ku
151-0053
Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku
160-0023
Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku
162-8555
Japan
Tottori University Hospital
Tottori, Yonago
683-0826
Japan
Instituto Nacional de Enfermedades Respiratorias Ismael CosÃo Villegas
Mexico City
14080
Mexico
OLVG, locatie Oosterpark
Amsterdam
1091 AC
Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein
3435 CM
Netherlands
Erasmus Medisch Centrum
Rotterdam
3015 CE
Netherlands
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra
3041-801
Portugal
CHLC, EPE - Hospital de Santa Marta
Lisbon
1196-024
Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Lisbon
1750-001 L
Portugal
Centro Hospitalar Universitário São João,EPE
Porto
4202-451
Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia
4434-502
Portugal
Scientific Research Institute of Pulmonology
Saint Petersburg
197022
Russia
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
420-767
South Korea
Gachon University Gil Medical Center
Incheon
405-760
South Korea
Seoul National University Hospital
Seoul
110-744
South Korea
Asan Medical Center
Seoul
138-736
South Korea
Soonchunhyang University Hospital Seoul
Seoul
140-743
South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul
150-713
South Korea
Hospital Vall d'Hebron
Barcelona
08035
Spain
Hospital ClÃnic de Barcelona
Barcelona
08036
Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat
08907
Spain
Hospital Nuestra Señora de Valme
Seville
41014
Spain
Ankara Universitesi Tip Fakultesi
Ankara
06100
Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul
34098
Turkey (Türkiye)
Yedikule Gog. Hst. EAH
Istanbul
34760
Turkey (Türkiye)
Ege Universitesi T.F.
Izmir
35100
Turkey (Türkiye)
Dr.Suat Seren EAH
Izmir
35120
Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
Queen Elizabeth Hospital
Birmingham
B15 2GW
United Kingdom
Birmingham Heartlands Hospital
Birmingham
B9 5SS
United Kingdom
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
Aintree University Hospital
Liverpool
L9 7AL
United Kingdom
Royal Brompton Hospital
London
SW3 6NP
United Kingdom
Churchill Hospital
Oxford
OX3 7LJ
United Kingdom
Southmead Hospital
Westbury on Trym
BS10 5NB
United Kingdom
FG000752 subjects
Treated
FG000751 subjects
COMPLETED
'completed' stands for not prematurely discontinued from trial medication
FG000227 subjects
NOT COMPLETED
FG000525 subjects
Type
Comment
Reasons
Adverse Event
FG000231 subjects
Protocol Violation
FG0004 subjects
Lost to Follow-up
FG0003 subjects
Withdrawal by Subject
FG00045 subjects
Other than specified
FG00096 subjects
Not treated
FG0001 subjects
Death
FG000145 subjects
Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 parent trials.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Total (1199.32/.34)
This group included patients originated from parent trials 1199.32/.34.
For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study.
In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Denominators
Units
Counts
Participants
BG000734
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
BG00067.2± 7.8
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000147
Male
BG000587
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
Asian
BG000214
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
Incidence of Adverse Events (AEs)
This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.
Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 parent trials.
Posted
Number
Percentage of patients (%)
From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.
ID
Title
Description
OG000
Total (1199.32/.34)
This group included patients originated from parent trials 1199.32/.34.
For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study.
In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
Units
Counts
Participants
OG000734
Title
Denominators
Categories
Any AEs
Title
Measurements
OG00098.5
AEs leading to discontinuation of trial drug
Title
Measurements
OG00042.6
Serious AEs
Time Frame
From first drug administration in this study until 28 days after the last drug, up to 7.5 years.
Description
Treated set (TS) [and TS35; TS187]: The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 [in 1199.35 for TS35; in 1199.187 for TS187] parent trials. TS (from 1199.32/.34), TS35 (from .35), and TS187 (from .187) are all used to reported the AEs.
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
Total (1199.32/.34)
This group included patients originated from parent trials 1199.32/.34.
For patients participated in parent trials 1199.32/.34, they were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study.
In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
182
734
509
734
671
734
EG001
Placebo (1199.32/.34)
Patients in this group are those who were randomized to placebo arm in parent trials 1199.32/.34 and were treated with 100 milligrams or 150 milligrams of nintedanib orally twice daily in this study.
78
304
208
304
281
304
EG002
Nintedanib 150 Bid (1199.32/.34)
Patients in this group are those who were randomized to 150 milligrams nintedanib twice daily (bid) arm in the parent trials 1199.32/.34 and were treated with 100 milligrams or 150 milligrams of nintedanib orally twice daily in this study.
104
430
301
430
390
430
EG003
Placebo (1199.187)
Patients in this group are those who were randomized to placebo arm in parent trial 1199.187 and were treated with 150 milligrams or 100 milligrams of nintedanib twice daily in this study.
0
7
0
7
3
7
EG004
Nintedanib 100 Bid (1199.35)
Patients in this group are those who were participated in the parent trial 1199.35 and were treated with 100 milligrams of nintedanib twice daily (bid) in this study.
0
2
0
2
1
2
EG005
Nintedanib 150 Bid (1199.35/.187)
Patients in this group are those who were treated with 150 milligrams (mg) of nintedanib twice daily (bid) in this study and were participated in parent trial 1199.35 plus those who were randomized to 150 mg nintedanib bid arm in the parent trial 1199.187 and were treated with 150 mg or 100 mg nintedanib bid in this study.
0
8
1
8
2
8
EG006
Total (1199.35/.187)
This group included patients originated from parent trials 1199.35/.187. For patients participated in parent trials 1199.35/.187, they were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 milligrams (mg) twice daily (bid) or 150 mg bid) in this study.
In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
0
17
1
17
6
17
EG007
Total (1199.32/.34/.35/.187)
For patients participated in parent trials 1199.32/.34 (both were randomized, placebo-controlled): patients were to receive continuous dosing of soft gelatin capsules of nintedanib (orally) 150 milligrams (mg) twice daily (bid) in this study unless they had reduced the dose to 100 mg bid trial drug (nintedanib or placebo) in the parent trial; patients receiving 100 mg bid trial drug at the end of the parent trial could receive either nintedanib 100 mg bid or nintedanib 150 mg bid in this study. The daily nintedanib dose for such patients was decided at baseline visit based on discussion between the patient and the investigator. After unblinding of the parent trials, patients randomized to placebo in parent trials, who reduced the dose to 100 mg bid in the parent trial, could increase the dose to nintedanib 150 mg bid in this study. The dose could also be increased to 150 mg at a later time point if medically justified in this study. For patients participated in parent trials 1199.35/.187 (1199.35: open label; 1199.187: randomized placebo-control): patients were to receive the same daily dosage of soft gelatin capsules of nintedanib (orally) as in the parent trials (100 mg bid or 150 mg bid) in this study. In this study, patients were treated with nintedanib until they met one of the discontinuation criteria. Potential reasons for treatment discontinuation include impaired liver function, recurrence of diarrhoea, and progression of idiopathic pulmonary fibrosis.
182
751
510
751
677
751
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG0030 affected7 at risk
EG0040 affected2 at risk
EG0050 affected8 at risk
EG0060 affected17 at risk
EG0072 affected751 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0006 affected734 at risk
EG0011 affected304 at risk
EG0025 affected430 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0013 affected304 at risk
EG0022 affected430 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0009 affected734 at risk
EG0016 affected304 at risk
EG0023 affected430 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0013 affected304 at risk
EG0021 affected430 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG00012 affected734 at risk
EG0016 affected304 at risk
EG0026 affected430 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0007 affected734 at risk
EG0011 affected304 at risk
EG0026 affected430 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Conduction disorder
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Cor pulmonale
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0008 affected734 at risk
EG0011 affected304 at risk
EG0027 affected430 at risk
EG003
Cor pulmonale chronic
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0009 affected734 at risk
EG0012 affected304 at risk
EG0027 affected430 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0006 affected734 at risk
EG0012 affected304 at risk
EG0024 affected430 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0011 affected304 at risk
EG0023 affected430 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0013 affected304 at risk
EG0022 affected430 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0013 affected304 at risk
EG0022 affected430 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0013 affected304 at risk
EG0020 affected430 at risk
EG003
Porokeratosis
Congenital, familial and genetic disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Amaurosis fugax
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Blindness transient
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Cataract
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Dry age-related macular degeneration
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Glaucoma
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Panophthalmitis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Periorbital fat herniation
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0013 affected304 at risk
EG0020 affected430 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00010 affected734 at risk
EG0015 affected304 at risk
EG0025 affected430 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Erosive oesophagitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0011 affected304 at risk
EG0023 affected430 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0011 affected304 at risk
EG0023 affected430 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0014 affected304 at risk
EG0020 affected430 at risk
EG003
Inguinal hernia, obstructive
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pancreatic pseudocyst
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0011 affected304 at risk
EG0023 affected430 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pancreatitis necrotising
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Protein-losing gastroenteropathy
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG00011 affected734 at risk
EG0013 affected304 at risk
EG0028 affected430 at risk
EG003
Complication associated with device
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Condition aggravated
General disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0011 affected304 at risk
EG0022 affected430 at risk
EG003
Death
General disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0010 affected304 at risk
EG0023 affected430 at risk
EG003
Disease progression
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0012 affected304 at risk
EG0022 affected430 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0011 affected304 at risk
EG0023 affected430 at risk
EG003
Sudden death
General disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0011 affected304 at risk
EG0024 affected430 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Biliary dyskinesia
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0011 affected304 at risk
EG0022 affected430 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0006 affected734 at risk
EG0014 affected304 at risk
EG0022 affected430 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0009 affected734 at risk
EG0014 affected304 at risk
EG0025 affected430 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Non-alcoholic steatohepatitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Biliary sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00012 affected734 at risk
EG0012 affected304 at risk
EG00210 affected430 at risk
EG003
Bronchitis bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Herpes simplex encephalitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Infected cyst
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0007 affected734 at risk
EG0014 affected304 at risk
EG0023 affected430 at risk
EG003
Intervertebral discitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0009 affected734 at risk
EG0014 affected304 at risk
EG0025 affected430 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Paraspinal abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Pleural infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00099 affected734 at risk
EG00140 affected304 at risk
EG00259 affected430 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0011 affected304 at risk
EG0024 affected430 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Postoperative abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Pulmonary mycosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00013 affected734 at risk
EG0018 affected304 at risk
EG0025 affected430 at risk
EG003
Respiratory tract infection bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0008 affected734 at risk
EG0013 affected304 at risk
EG0025 affected430 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Spinal cord abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Tinea capitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0007 affected734 at risk
EG0011 affected304 at risk
EG0026 affected430 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0012 affected304 at risk
EG0022 affected430 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Carbon monoxide poisoning
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0006 affected734 at risk
EG0014 affected304 at risk
EG0022 affected430 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0014 affected304 at risk
EG0020 affected430 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Hypobarism
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Postoperative delirium
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0013 affected304 at risk
EG0021 affected430 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0011 affected304 at risk
EG0022 affected430 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Traumatic haemothorax
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Blood urea increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Body temperature increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0012 affected304 at risk
EG0023 affected430 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0011 affected304 at risk
EG0023 affected430 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0010 affected304 at risk
EG0023 affected430 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Chondropathy
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0011 affected304 at risk
EG0022 affected430 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0008 affected734 at risk
EG0012 affected304 at risk
EG0026 affected430 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Bladder cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0010 affected304 at risk
EG0023 affected430 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0007 affected734 at risk
EG0014 affected304 at risk
EG0023 affected430 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG00013 affected734 at risk
EG0014 affected304 at risk
EG0029 affected430 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Metastases to eye
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Metastatic squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Neuroendocrine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pleural neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0011 affected304 at risk
EG0024 affected430 at risk
EG003
Prostatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0006 affected734 at risk
EG0012 affected304 at risk
EG0024 affected430 at risk
EG003
Small intestine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0008 affected734 at risk
EG0014 affected304 at risk
EG0024 affected430 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0011 affected304 at risk
EG0023 affected430 at risk
EG003
Tumour of ampulla of Vater
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Brain hypoxia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Cerebral artery occlusion
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Cerebral artery stenosis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Cerebral atrophy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0010 affected304 at risk
EG0023 affected430 at risk
EG003
Coma
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0009 affected734 at risk
EG0013 affected304 at risk
EG0026 affected430 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0012 affected304 at risk
EG0023 affected430 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0007 affected734 at risk
EG0013 affected304 at risk
EG0024 affected430 at risk
EG003
Anuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Glomerulonephritis chronic
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Lower urinary tract symptoms
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Obstructive nephropathy
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0013 affected304 at risk
EG0022 affected430 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0013 affected304 at risk
EG0022 affected430 at risk
EG003
Genital prolapse
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00015 affected734 at risk
EG0014 affected304 at risk
EG00211 affected430 at risk
EG003
Bronchopleural fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Chronic respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected734 at risk
EG0011 affected304 at risk
EG0024 affected430 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00038 affected734 at risk
EG00116 affected304 at risk
EG00222 affected430 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0010 affected304 at risk
EG0023 affected430 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0012 affected304 at risk
EG0022 affected430 at risk
EG003
Hypercapnia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00013 affected734 at risk
EG0019 affected304 at risk
EG0024 affected430 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG000153 affected734 at risk
EG00164 affected304 at risk
EG00289 affected430 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00010 affected734 at risk
EG0013 affected304 at risk
EG0027 affected430 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0011 affected304 at risk
EG0022 affected430 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0012 affected304 at risk
EG0021 affected430 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00015 affected734 at risk
EG0016 affected304 at risk
EG0029 affected430 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pulmonary arterial hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00011 affected734 at risk
EG0015 affected304 at risk
EG0026 affected430 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00017 affected734 at risk
EG00111 affected304 at risk
EG0026 affected430 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00012 affected734 at risk
EG0013 affected304 at risk
EG0029 affected430 at risk
EG003
Pulmonary granuloma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00048 affected734 at risk
EG00122 affected304 at risk
EG00226 affected430 at risk
EG003
Pulmonary infarction
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0011 affected304 at risk
EG0021 affected430 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected734 at risk
EG0012 affected304 at risk
EG0022 affected430 at risk
EG003
Respiratory acidosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00035 affected734 at risk
EG0019 affected304 at risk
EG00226 affected430 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Knee arthroplasty
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Transurethral prostatectomy
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0011 affected304 at risk
EG0022 affected430 at risk
EG003
Arterial thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected734 at risk
EG0010 affected304 at risk
EG0023 affected430 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Shock
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0012 affected304 at risk
EG0020 affected430 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Prosthetic cardiac valve thrombosis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Vascular stent stenosis
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Congestive hepatopathy
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Hepatic mass
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected734 at risk
EG0010 affected304 at risk
EG0022 affected430 at risk
EG003
Complicated appendicitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Infective exacerbation of bronchiectasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Post procedural fever
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Imaging procedure abnormal
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Cutaneous T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0010 affected304 at risk
EG0021 affected430 at risk
EG003
Cyanosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected734 at risk
EG0011 affected304 at risk
EG0020 affected430 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00063 affected734 at risk
EG00132 affected304 at risk
EG00231 affected430 at risk
EG0030 affected7 at risk
EG0040 affected2 at risk
EG0050 affected8 at risk
EG0060 affected17 at risk
EG00763 affected751 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00048 affected734 at risk
EG00121 affected304 at risk
EG00227 affected430 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00057 affected734 at risk
EG00126 affected304 at risk
EG00231 affected430 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG000514 affected734 at risk
EG001213 affected304 at risk
EG002301 affected430 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG000146 affected734 at risk
EG00170 affected304 at risk
EG00276 affected430 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG00089 affected734 at risk
EG00136 affected304 at risk
EG00253 affected430 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG00039 affected734 at risk
EG00118 affected304 at risk
EG00221 affected430 at risk
EG003
Chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG00039 affected734 at risk
EG00115 affected304 at risk
EG00224 affected430 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG00068 affected734 at risk
EG00132 affected304 at risk
EG00236 affected430 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG00050 affected734 at risk
EG00117 affected304 at risk
EG00233 affected430 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG00042 affected734 at risk
EG00115 affected304 at risk
EG00227 affected430 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG000145 affected734 at risk
EG00154 affected304 at risk
EG00291 affected430 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00040 affected734 at risk
EG00114 affected304 at risk
EG00226 affected430 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00047 affected734 at risk
EG00115 affected304 at risk
EG00232 affected430 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00039 affected734 at risk
EG00118 affected304 at risk
EG00221 affected430 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG000109 affected734 at risk
EG00138 affected304 at risk
EG00271 affected430 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG000123 affected734 at risk
EG00163 affected304 at risk
EG00260 affected430 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG000104 affected734 at risk
EG00158 affected304 at risk
EG00246 affected430 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG00049 affected734 at risk
EG00118 affected304 at risk
EG00231 affected430 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG00057 affected734 at risk
EG00128 affected304 at risk
EG00229 affected430 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG00048 affected734 at risk
EG00123 affected304 at risk
EG00225 affected430 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG00042 affected734 at risk
EG00118 affected304 at risk
EG00224 affected430 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG000166 affected734 at risk
EG00166 affected304 at risk
EG002100 affected430 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG000118 affected734 at risk
EG00148 affected304 at risk
EG00270 affected430 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00080 affected734 at risk
EG00132 affected304 at risk
EG00248 affected430 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG00049 affected734 at risk
EG00123 affected304 at risk
EG00226 affected430 at risk
EG003
Cataract
Eye disorders
MedDRA 23.1
Systematic Assessment
EG00026 affected734 at risk
EG0018 affected304 at risk
EG00218 affected430 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00035 affected734 at risk
EG00111 affected304 at risk
EG00224 affected430 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG000152 affected734 at risk
EG00162 affected304 at risk
EG00290 affected430 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00045 affected734 at risk
EG00119 affected304 at risk
EG00226 affected430 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG00021 affected734 at risk
EG00110 affected304 at risk
EG00211 affected430 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG00026 affected734 at risk
EG00117 affected304 at risk
EG0029 affected430 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG00036 affected734 at risk
EG00114 affected304 at risk
EG00222 affected430 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG00036 affected734 at risk
EG00112 affected304 at risk
EG00224 affected430 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.