A Study of Nivolumab in Advanced Non-Small Cell Lung Canc... | NCT02574078 | Trialant
NCT02574078
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
May 6, 2021Actual
Enrollment
341Actual
Phase
Phase 1Phase 2
Conditions
Non-Small Cell Lung Cancer
Interventions
Nivolumab
Bevacizumab
Pemetrexed
Best Supportive Care
nab-Paclitaxel
Paclitaxel
Docetaxel
Gemcitabine
Erlotinib
Crizotinib
Carboplatin
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02574078
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA209-370
Secondary IDs
Not provided
Brief Title
A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)
Acronym
CheckMate370
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Apr 2021
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
Nov 23, 2015Actual
Primary Completion Date
Apr 15, 2020Actual
Completion Date
Apr 15, 2020Actual
First Submitted Date
Oct 9, 2015
First Submission Date that Met QC Criteria
Oct 9, 2015
First Posted Date
Oct 12, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 15, 2021
Results First Submitted that Met QC Criteria
Apr 12, 2021
Results First Posted Date
May 6, 2021Actual
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
Apr 12, 2021
Last Update Posted Date
May 6, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.
**Please note that the study is no longer enrolling patients for Groups A, B, C, and E.
Conditions Module
Conditions
Non-Small Cell Lung Cancer
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
341Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A Nivolumab
Experimental
Opdivo specified dose on specified days
Drug: Nivolumab
Group A Nivolumab + SOC maintenance therapy
Experimental
Opdivo/Bevacizumab specified dose on specified days
Opdivo/Pemetrexed specified dose on specified days
Drug: Nivolumab
Drug: Bevacizumab
Drug: Pemetrexed
Group A SOC maintenance therapy
Active Comparator
Bevacizumab specified dose on specified days
Pemetrexed specified dose on specified days
Drug: Bevacizumab
Drug: Pemetrexed
Group B Nivolumab
Experimental
Opdivo specified dose on specified days
Drug: Nivolumab
Group B Best supportive care
Other
Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery
Other: Best Supportive Care
Group C Investigator's choice chemotherapy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nivolumab
Drug
Group A Nivolumab
Group A Nivolumab + SOC maintenance therapy
Group B Nivolumab
Group C Nivolumb
Group D Nivolumab + Erlotinib
Group E Nivolumab + Crizotinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression-Free Survival (PFS), Groups A-D Only
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
up to approximately 48 months
Overall Survival (OS), Groups A-C Only
Overall survival (OS) is defined as the time from randomization to the date of death.
up to approximately 60 months
Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only
Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.
up to approximately 60 months
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DOR), Groups A-D Only
Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Median computed using Kaplan-Meier method.
up to approximately 48 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Histologically confirmed locally advanced or stage IV NSCLC
Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
Tumor tissue sections must be available for biomarker evaluation
Exclusion Criteria:
Untreated or active/progressing Central Nervous system (CNS) metastases
Active, known or suspected autoimmune disease
Known history of testing positive for HIV or AIDS
Active or chronic infection of hepatitis B virus or hepatitis C
Groups A-D: 328 participants randomized, 314 treated and 14 not treated. Reasons not treated: Group A - 1 no longer met criteria; Group B - 3 withdrew consent, 2 no longer met criteria, 2 other; Group C - 1 no longer met criteria; Group D - 2 withdrew consent, 1 poor/non-compliance, 2 other.
Group E: 13 participants treated.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A, Cohort A, Nivo
Nivolumab 240 mg every 2 weeks.
FG001
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
Periods
Title
Milestones
Reasons Not Completed
Pre-Treatment Period
Type
Comment
Milestone Data
STARTED
Started = Randomized (entering treatment)
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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 26, 2018
Mar 15, 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
Randomized
Intervention Model
Parallel 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
Active Comparator
Carboplatin/nab-paclitaxel specified dose on specified days
Carboplatin/paclitaxel specified dose on specified days
Carboplatin/pemetrexed specified dose on specified days
Carboplatin/docetaxel specified dose on specified days
Carboplatin/gemcitabine specified dose on specified days
Paclitaxel specified dose on specified days
Docetaxel specified dose on specified days
Gemcitabine specified dose on specified days
Pemetrexed specified dose on specified days
Drug: Pemetrexed
Drug: nab-Paclitaxel
Drug: Paclitaxel
Drug: Docetaxel
Drug: Gemcitabine
Drug: Carboplatin
Group C Nivolumb
Experimental
Opdivo specified dose on specified days
Drug: Nivolumab
Group D Erlotinib
Active Comparator
Erlotinib specified dose on specified days
Drug: Erlotinib
Group D Nivolumab + Erlotinib
Experimental
Opdivo/Erlotnib specified dose on specified days
Drug: Nivolumab
Drug: Erlotinib
Group E Nivolumab + Crizotinib
Experimental
Opdivo/Crizotinib specified dose on specified days
Drug: Nivolumab
Drug: Crizotinib
Opdivo
Bevacizumab
Drug
Group A Nivolumab + SOC maintenance therapy
Group A SOC maintenance therapy
Pemetrexed
Drug
Group A Nivolumab + SOC maintenance therapy
Group A SOC maintenance therapy
Group C Investigator's choice chemotherapy
Best Supportive Care
Other
Palliative radiation, palliative surgery and/or other best supportive care treatments
Group B Best supportive care
nab-Paclitaxel
Drug
Group C Investigator's choice chemotherapy
Paclitaxel
Drug
Group C Investigator's choice chemotherapy
Docetaxel
Drug
Group C Investigator's choice chemotherapy
Gemcitabine
Drug
Group C Investigator's choice chemotherapy
Erlotinib
Drug
Group D Erlotinib
Group D Nivolumab + Erlotinib
Crizotinib
Drug
Group E Nivolumab + Crizotinib
Carboplatin
Drug
Group C Investigator's choice chemotherapy
Objective Response Rate (ORR), Groups A-E
Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Confidence interval based on the Clopper and Pearson method.
up to approximately 48 months
Overall Survival (OS), Group D Only
Overall survival (OS) is defined as the time from randomization to the date of death.
up to approximately 60 months
Progression-Free Survival (PFS), Group E Only
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
FG005
Group A, Cohort B, Peme
Pemetrexed 500 mg/m^2 every 3 weeks.
FG006
Group B, Nivo
Nivolumab 240 mg every 2 weeks.
FG007
Group B, BSC
Best Supportive Care (BSC)
FG008
Group C, Nivo
Nivolumab 240 mg every 2 weeks.
FG009
Group C, ICC
Investigator's Choice of Chemotherapy
FG010
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
FG011
Group D, Erlo
Erlotinib 150 mg QD.
FG012
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
FG00013 subjects
FG0016 subjects
FG0029 subjects
FG00335 subjects
FG00434 subjects
FG00535 subjects
FG00618 subjects
FG00717 subjects
FG00826 subjects
FG00926 subjects
FG01053 subjects
FG01156 subjects
FG01213 subjects
COMPLETED
Finished = Treated
FG00013 subjects
FG0016 subjects
FG0029 subjects
FG00335 subjects
FG00434 subjects
FG00534 subjects
FG00614 subjects
FG00714 subjects
FG00825 subjects
FG00926 subjects
FG01049 subjects
FG01155 subjects
FG01213 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0064 subjects
FG0073 subjects
FG0081 subjects
FG0090 subjects
FG0104 subjects
FG0111 subjects
FG0120 subjects
Type
Comment
Reasons
Participant no longer meets study criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Participant withdrew consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Poor/non-compliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Treatment Period
Type
Comment
Milestone Data
STARTED
Started = Treated
FG00013 subjects
FG0016 subjects
FG0029 subjects
FG00335 subjects
FG00434 subjects
FG00534 subjects
FG00614 subjects
FG00714 subjects
FG00825 subjects
FG00926 subjects
FG01049 subjects
FG01155 subjects
FG01213 subjects
COMPLETED
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0037 subjects
FG004
NOT COMPLETED
FG00010 subjects
FG0016 subjects
FG0029 subjects
FG00328 subjects
FG004
Type
Comment
Reasons
Disease progression
FG0006 subjects
FG0014 subjects
FG0027 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A, Cohort A, Nivo
Nivolumab 240 mg every 2 weeks.
BG001
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
BG002
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
BG003
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
BG004
Group A, Cohort B, Peme + Nivo
Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
BG005
Group A, Cohort B, Peme
Pemetrexed 500 mg/m^2 every 3 weeks.
BG006
Group B, Nivo
Nivolumab 240 mg every 2 weeks.
BG007
Group B, BSC
Best Supportive Care (BSC)
BG008
Group C, Nivo
Nivolumab 240 mg every 2 weeks.
BG009
Group C, ICC
Investigator's Choice of Chemotherapy
BG010
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
BG011
Group D, Erlo
Erlotinib 150 mg QD.
BG012
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00013
BG0016
BG0029
BG00335
BG00434
BG00535
BG00618
BG00717
BG00826
BG00926
BG01053
BG01156
BG01213
BG013341
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
< 65 years old
BG0008
BG0012
BG0021
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Progression-Free Survival (PFS), Groups A-D Only
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
All randomized participants in Groups A-D only
Posted
Median
95% Confidence Interval
Months
up to approximately 48 months
ID
Title
Description
OG000
Group A, Cohort A, Nivo
Nivolumab 240 mg every 2 weeks.
OG001
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
OG002
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
OG003
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
OG004
Group A, Cohort B, Peme + Nivo
Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
OG005
Group A, Cohort B, Peme
Pemetrexed 500 mg/m^2 every 3 weeks.
OG006
Group B, Nivo
Nivolumab 240 mg every 2 weeks.
OG007
Group B, BSC
Best Supportive Care (BSC)
OG008
Group C, Nivo
Nivolumab 240 mg every 2 weeks.
OG009
Group C, ICC
Investigator's Choice of Chemotherapy
OG010
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
OG011
Group D, Erlo
Erlotinib 150 mg QD.
Units
Counts
Participants
OG00013
OG0016
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG00015.0(1.4 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
OG0016.7(4.1 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
OG002
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Unstratified log-rank
0.5050
Hazard Ratio (HR)
0.70
2-Sided
95
0.24
2.03
Superiority
OG001
OG002
Unstratified log-rank
0.6284
Primary
Overall Survival (OS), Groups A-C Only
Overall survival (OS) is defined as the time from randomization to the date of death.
All randomized participants in Groups A-C only
Posted
Median
95% Confidence Interval
Months
up to approximately 60 months
ID
Title
Description
OG000
Group A, Cohort A, Nivo
Nivolumab 240 mg every 2 weeks.
OG001
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
OG002
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
OG003
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
OG004
Group A, Cohort B, Peme + Nivo
Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
Primary
Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only
Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.
All treated participants in Group E only
Posted
Number
Percentage of participants
up to approximately 60 months
ID
Title
Description
OG000
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
Units
Counts
Participants
OG00013
Secondary
Duration of Response (DOR), Groups A-D Only
Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Median computed using Kaplan-Meier method.
All responders (participants with objective response of CR or PR) in Groups A-D only.
Posted
Median
95% Confidence Interval
months
up to approximately 48 months
ID
Title
Description
OG000
Group A, Cohort A, Nivo
Nivolumab 240 mg every 2 weeks.
OG001
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
OG002
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
OG003
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
Secondary
Objective Response Rate (ORR), Groups A-E
Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Confidence interval based on the Clopper and Pearson method.
All randomized (Groups A-D) and treated (Group E) participants with at least one lesion at baseline
Posted
Number
95% Confidence Interval
Percentage of participants
up to approximately 48 months
ID
Title
Description
OG000
Group A, Cohort A, Nivo
Nivolumab 240 mg every 2 weeks.
OG001
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
OG002
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
OG003
Group A, Cohort B, Nivo
Secondary
Overall Survival (OS), Group D Only
Overall survival (OS) is defined as the time from randomization to the date of death.
All randomized participants in Group D only
Posted
Median
95% Confidence Interval
months
up to approximately 60 months
ID
Title
Description
OG000
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
OG001
Group D, Erlo
Erlotinib 150 mg QD.
Units
Counts
Participants
OG000
Secondary
Progression-Free Survival (PFS), Group E Only
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
All treated participants in Group E only
Posted
Median
95% Confidence Interval
months
up to approximately 48 months
ID
Title
Description
OG000
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
Units
Counts
Participants
OG00013
Time Frame
Treated population: From first dose to 100 days post last dose (approximately 60 months)
Description
Not provided
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
SUB-STUDY A, COHORT A: NIVOLUMAB 240 MG
Nivolumab 240 mg every 2 weeks.
8
13
6
13
12
13
EG001
SUB-STUDY A: BEVACIZUMAB + NIVOLUMAB 5 MG/KG
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
4
6
1
6
6
6
EG002
SUB-STUDY A: BEVACIZUMAB
Bevacizumab 15 mg/kg every 3 weeks.
6
9
5
9
9
9
EG003
SUB-STUDY A, COHORT B: NIVOLUMAB 240 MG
Nivolumab 240 mg every 2 weeks.
24
35
15
35
35
35
EG004
SUB-STUDY A: PEMETREXED + NIVOLUMAB 5 MG/KG
Pemetrexed 500 mg/m^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
23
34
16
34
32
34
EG005
SUB-STUDY A: PEMETREXED
Pemetrexed 500 mg/m^2 every 3 weeks.
24
34
14
34
33
34
EG006
SUB-STUDY B: NIVOLUMAB 240 MG
Nivolumab 240 mg every 2 weeks.
5
14
5
14
13
14
EG007
SUB-STUDY B: BEST SUPPORTIVE CARE
Best Supportive Care (BSC)
9
14
7
14
13
14
EG008
SUB-STUDY C: NIVOLUMAB 240 MG
Nivolumab 240 mg every 2 weeks.
23
25
23
25
22
25
EG009
SUB-STUDY C: INVESTIGATOR'S CHOICE OF CHEMOTHERAPY
Investigator's Choice of Chemotherapy (ICC)
18
26
7
26
25
26
EG010
SUB-STUDY D: NIVOLUMAB 240 MG + ERLOTINIB
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
20
49
25
49
49
49
EG011
SUB-STUDY D: ERLOTINIB
Erlotinib 150 mg QD.
25
55
17
55
55
55
EG012
SUB-STUDY E: SINGLE ARM: NIVOLUMAB 240 MG + CRIZOTINIB
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
7
13
8
13
13
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG0030 affected35 at risk
EG0040 affected34 at risk
EG0050 affected34 at risk
EG0060 affected14 at risk
EG0070 affected14 at risk
EG0080 affected25 at risk
EG0090 affected26 at risk
EG0101 affected49 at risk
EG0110 affected55 at risk
EG0120 affected13 at risk
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Incarcerated hernia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cyclosporidium infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cytomegalovirus gastrointestinal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Empyema
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Paraspinal abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pharyngeal abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected6 at risk
EG0023 affected9 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Wound infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Ilium fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Blood glucose increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Liver function test increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Autoimmune arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Central nervous system lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Neuroendocrine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Seizure like phenomena
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0022 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Mediastinal haematoma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0022 affected9 at risk
EG0034 affected35 at risk
EG00411 affected34 at risk
EG0058 affected34 at risk
EG0060 affected14 at risk
EG0072 affected14 at risk
EG0083 affected25 at risk
EG0095 affected26 at risk
EG01016 affected49 at risk
EG01110 affected55 at risk
EG0123 affected13 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Metamorphopsia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Photopsia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected6 at risk
EG0021 affected9 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected13 at risk
EG0013 affected6 at risk
EG0025 affected9 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 affected13 at risk
EG0012 affected6 at risk
EG0022 affected9 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected6 at risk
EG0021 affected9 at risk
EG003
Axillary pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cyst
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Generalised oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Localised oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Mass
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Mucosal pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0022 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected6 at risk
EG0022 affected9 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0022 affected9 at risk
EG003
Swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Contrast media reaction
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Paronychia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0022 affected9 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0022 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0022 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0022 affected9 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0003 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Blood urea increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Influenza A virus test positive
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Protein total decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Troponin I increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Troponin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Weight increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected13 at risk
EG0012 affected6 at risk
EG0023 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0022 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0022 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Vitamin C deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected13 at risk
EG0011 affected6 at risk
EG0022 affected9 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0004 affected13 at risk
EG0011 affected6 at risk
EG0022 affected9 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Drooling
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected6 at risk
EG0022 affected9 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Migraine
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Device occlusion
Product Issues
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected6 at risk
EG0021 affected9 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Bladder diverticulum
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected6 at risk
EG0021 affected9 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 affected13 at risk
EG0014 affected6 at risk
EG0022 affected9 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0021 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0022 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Reflux laryngitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0021 affected9 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Use of accessory respiratory muscles
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected6 at risk
EG0020 affected9 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected6 at risk
EG0020 affected9 at risk
EG003
Drug reaction with eosinophilia and systemic symptoms