Phase I/II AZD8931/Paclitaxel in Treatment of Advanced So... | NCT00900627 | Trialant
NCT00900627
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Jan 20, 2016Estimated
Enrollment
330Actual
Phase
Phase 1Phase 2
Conditions
Neoplasms
Breast Neoplasms
Breast Cancer
Interventions
AZD8931
Paclitaxel
Placebo
Countries
Belgium
Brazil
Bulgaria
Canada
Czechia
France
Hungary
Italy
Panama
Peru
Spain
Sweden
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00900627
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D0102C00003
Secondary IDs
Not provided
Brief Title
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
Official Title
A Phase I/II Multi-centre Study of AZD8931 in Combination With Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and in a Selected Population With Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer
Acronym
THYME
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Jan 2016
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 2009
Primary Completion Date
Apr 2012Actual
Completion Date
Feb 2015Actual
First Submitted Date
May 12, 2009
First Submission Date that Met QC Criteria
May 12, 2009
First Posted Date
May 13, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 31, 2014
Results First Submitted that Met QC Criteria
Sep 23, 2014
Results First Posted Date
Sep 29, 2014Estimated
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
Jan 15, 2016
Last Update Posted Date
Jan 20, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
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 main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Breast Neoplasms
Breast Cancer
Keywords
Cancer
Tumour
Breast cancer
Metastatic
Secondary
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
330Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
AZD8931 plus Paclitaxel
Drug: AZD8931
Drug: Paclitaxel
2
Placebo Comparator
Placebo plus Paclitaxel
Drug: Paclitaxel
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD8931
Drug
Tablet Oral bid
1
Paclitaxel
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.
Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant
Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)
Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012
Secondary Outcomes
Measure
Description
Time Frame
Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
The number of subjects with at least one visit response of CR or PR (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline))
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)
Suitable for paclitaxel chemotherapy
Life expectancy more than 12 weeks
Exclusion Criteria:
Inadequate kidney, liver, heart, gastric, lung or eye function
Hypersensitive to paclitaxel
No symptomatic uncontrolled brain metastases
Previous taxane chemotherapy within 12 months (Phase II)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
150 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Dr Serban Ghiorghiu
AstraZeneca
Study Director
Professor Jose Baselga
Vall d'Hebron University Hospital
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Brussels (Jette)
Belgium
Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Phase I: 20 patients enrolled, 6 to AZD8931 160mg, 2 to AZD8931 120 mg, 6 to AZD8931 80 mg and 6 to AZD8931 40mg. Phase II: 305 enrolled, 190 randomised, 94 and 96 allocated to AZD8931 40mg + Paclitaxel and Placebo + Paclitaxel respectively. Enrolled patients differs slightly from protocol as focus was on achieving number to be randomised.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AZD8931 160 mg bd
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
FG001
AZD8931 120 mg bd
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
IV once weekly for 3 weeks followed by a week off (repeated cycles)
1
2
Taxol
Placebo
Drug
Oral bid (twice daily)
2
Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012
Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
The time from the date of randomization until the date of death due to any cause.
Weekly visits for routine safety monitoring, accessed up to data cut off on 11th April 2012
Leuven
Belgium
Research Site
Namur
Belgium
Research Site
Sint-Niklaas
Belgium
Research Site
São Paulo
Brazil
Research Site
Sofia
Bulgaria
Research Site
Stara Zagora
Bulgaria
Research Site
Varna
Bulgaria
Research Site
Vratsa
Bulgaria
Research Site
Halifax
Nova Scotia
Canada
Research Site
London
Ontario
Canada
Research Site
Ottawa
Ontario
Canada
Research Site
Brno
Czechia
Research Site
Jičín
Czechia
Research Site
Olomouc
Czechia
Research Site
Prague
Czechia
Research Site
Praha 4 - Krc
Czechia
Research Site
Znojmo
Czechia
Research Site
Villejuif
France
Research Site
Budapest
Hungary
Research Site
Debrecen
Hungary
Research Site
Győr
Hungary
Research Site
Szeged
Hungary
Research Site
Lido di Camaiore
Italy
Research Site
Modena
Italy
Research Site
Treviglio
Italy
Research Site
Panama City
Panama
Research Site
Lima
Peru
Research Site
Barcelona
Spain
Research Site
Madrid
Spain
Research Site
Valencia
Spain
Research Site
Uppsala
Sweden
Research Site
Chur
Switzerland
Research Site
Glasgow
United Kingdom
Research Site
Leicester
United Kingdom
Research Site
London
United Kingdom
Research Site
Nottingham
United Kingdom
Research Site
Surrey
United Kingdom
FG002
AZD8931 80 mg bd
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
FG003
AZD8931 40 mg bd
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
FG004
AZD8931 40MG bd + Paclitaxel
Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
FG005
Placebo + Paclitaxel
Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
FG0006 subjects
FG0012 subjects
FG0026 subjects
FG0036 subjects
FG00494 subjectsThe values under 'Not Completed' are based on the time of the primary analysis
FG00596 subjectsThe values under 'Not Completed' are based on the time of the primary analysis
COMPLETED
FG0000 subjectsNo set completion, patients were to remain in study until withdrawn
FG0010 subjectsNo set completion, patients were to remain in study until withdrawn
FG0020 subjectsNo set completion, patients were to remain in study until withdrawn
FG0030 subjectsNo set completion, patients were to remain in study until withdrawn
FG00465 subjectsNo set completion, pts were to remain in study until withdrawn
FG00570 subjectsNo set completion, patients were to remain in study until withdrawn
NOT COMPLETED
FG0006 subjects
FG0012 subjects
FG0026 subjects
FG0036 subjects
FG00429 subjects
FG00526 subjects
Type
Comment
Reasons
Condition under investigation worsened
FG0004 subjects
FG0010 subjects
FG0025 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0033 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AZD8931 160 mg bd
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
BG001
AZD8931 120 mg bd
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
BG002
AZD8931 80 mg bd
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
BG003
AZD8931 40 mg bd
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
BG004
AZD8931 40MG bd + Paclitaxel
Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
BG005
Placebo + Paclitaxel
Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0012
BG0026
BG0036
BG00494
BG00596
BG006210
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Age at informed consent date
Mean
Standard Deviation
Years
Title
Denominators
Categories
Age for Part A
Title
Measurements
BG00052.7± 11.78
BG00162.0± 16.97
BG00247.2± 5.85
BG003
Age, Customized
Age in years
Number
Participants
Title
Denominators
Categories
< = 65 years
Title
Measurements
BG000NACustomized age tables were not presented for Part A
BG001NACustomized age tables were not presented for Part A
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0012
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Race: American Indian or Alaskan Native
Title
Measurements
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Ethnicity: Hispanic or Latino
Title
Measurements
BG0006
BG0012
BG002
Stratification: Prior taxane (This stratification information iis based on CRF data).
Prior taxane in adjuvant setting
Number
Participants
Title
Denominators
Categories
Prior taxane: Yes
Title
Measurements
BG000NANot applicable for Part A
BG001NANot applicable for Part A
Stratification: Hormone receptor status (This stratification information iis based on CRF data).
Hormone receptor status
Number
Participants
Title
Denominators
Categories
Hormone receptor status Positive [ER+ and/or PgR+]
Title
Measurements
BG000NANot applicable for Part A
BG001NA
Stratification: Prior chemotherapy (This stratification information iis based on CRF data).
Prior chemotherapy for locally advanced (not amenable to surgery) or metastatic breast cancer
Number
Participants
Title
Denominators
Categories
Prior chemotherapy: Yes
Title
Measurements
BG000NANot applicable for Part A
BG001
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
Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel
DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.
Safety population (all participants who received at least one dose)
Posted
Number
Number of Dose Limiting Toxicities
Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant
ID
Title
Description
OG000
AZD8931 160 mg bd
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
OG001
AZD8931 120 mg bd
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
OG002
AZD8931 80 mg bd
Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
OG003
AZD8931 40 mg bd
Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Total
Title
Measurements
OG0002
OG0011
OG0022
OG003
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
OG001
OG002
OG003
A tolerated dose was defined as one where ≤25% of the patients experienced a DLT. If a dose was tolerated, an increased dose was to be investigated in another group of 3-6 evaluable patients. A non-tolerated dose was defined as one where >25% of the patients experience a DLT. If a dose was non tolerated, a decreased/intermediate dose could be investigated in another group of 3-6 evaluable patients. The maximum tolerated dose was determined as the maximum dose level that was defined as tolerated.
Maximum Tolerated Dose
40
Dosing started at 160mg. Based on the data seen, 240mg with 33% patients with DLTs, 120mg with 50% patients with DLTs, 80mg with 33% of patients with DLTs and 40mg with 0% patients with DLTs, 40mg was deemed the maximum tolerated dose.
Primary
Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)
Full Analysis Set
Posted
Median
Inter-Quartile Range
Months
Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012
events
Participants
ID
Title
Description
OG000
AZD8931 40MG bd + Paclitaxel
Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
OG001
Placebo + Paclitaxel
Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
Units
Counts
Participants
OG000
Secondary
Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
The number of subjects with at least one visit response of CR or PR (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline))
Evaluable for response set (EFR set is all FAS patients with measureable disease at baseline)
Posted
Number
Participants
Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012
ID
Title
Description
OG000
AZD8931 40MG bd + Paclitaxel
Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
OG001
Placebo + Paclitaxel
Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
Secondary
Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone
The time from the date of randomization until the date of death due to any cause.
Full Analysis Set
Posted
Median
Inter-Quartile Range
Months
Weekly visits for routine safety monitoring, accessed up to data cut off on 11th April 2012
events
Participants
ID
Title
Description
OG000
AZD8931 40MG bd + Paclitaxel
Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
OG001
Placebo + Paclitaxel
Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
Units
Counts
Participants
OG000
Time Frame
AEs will be collected from time of signed informed consent throughout the treatment period and including the 30-day safety follow up period after the last dose of study treatment
Description
In part B, SAEs considered related to study procedures should continue to be collected while patients are followed up for disease progression.
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
AZD8931 40 mg bd
4
6
6
6
EG001
AZD8931 80 mg bd
2
6
6
6
EG002
AZD8931 120 mg bd
Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
1
2
2
2
EG003
AZD8931 160 mg bd
Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
3
6
6
6
EG004
AZD8931 40MG bd + Paclitaxel
24
94
93
94
EG005
Placebo + Paclitaxel
14
95
94
95
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected94 at risk
EG0050 events0 affected95 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PLEURAL INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BODY TEMPERATURE INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYDROTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
KERATITIS
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OESOPHAGITIS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CATHETER SITE INFLAMMATION
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PYREXIA
General disorders
MedDRA 14-15
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CATHETER SITE INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DEVICE RELATED SEPSIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PNEUMONIA PRIMARY ATYPICAL
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PSEUDOMONAS INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RASH PUSTULAR
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HUMERUS FRACTURE
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PUBIS FRACTURE
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MYOPATHY
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CONVULSION
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VERTEBROBASILAR INSUFFICIENCY
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VOCAL CORD PARALYSIS
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RENAL FAILURE ACUTE
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BREAST FIBROSIS
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected2 at risk
EG003
PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN NECROSIS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
THROMBOSIS
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected6 at risk
EG00434 events23 affected94 at risk
EG00514 events10 affected95 at risk
GRANULOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LYMPH NODE PAIN
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ANGINA UNSTABLE
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PERICARDIAL EFFUSION
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VENTRICULAR EXTRASYSTOLES
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DEAFNESS
Ear and labyrinth disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EAR DISCOMFORT
Ear and labyrinth disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VERTIGO POSITIONAL
Ear and labyrinth disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ADDISON'S DISEASE
Endocrine disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ASTHENOPIA
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BLEPHARITIS
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CATARACT
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CONJUNCTIVAL DISORDER
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CONJUNCTIVITIS
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DRY EYE
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ERYTHEMA OF EYELID
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EXOPHTHALMOS
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EXTRAOCULAR MUSCLE PARESIS
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EYE DISORDER
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EYE HAEMORRHAGE
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EYE IRRITATION
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EYE PAIN
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EYE PRURITUS
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EYELID OEDEMA
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
KERATITIS
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MACULAR DEGENERATION
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MYOPIA
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OCULAR HYPERAEMIA
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OCULAR TOXICITY
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PHOTOPHOBIA
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PUNCTATE KERATITIS
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SCLERAL HYPERAEMIA
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VISUAL ACUITY REDUCED
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
XEROPHTHALMIA
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0016 events4 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ANAL FISSURE
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ANAL INFLAMMATION
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ANAL PRURITUS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
APHTHOUS STOMATITIS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CHAPPED LIPS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CHEILITIS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG00012 events5 affected6 at risk
EG00125 events6 affected6 at risk
EG0023 events2 affected2 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EPIGASTRIC DISCOMFORT
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GASTRIC DISORDER
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GASTRIC ULCER
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GINGIVAL BLEEDING
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GINGIVITIS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GLOSSITIS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GLOSSODYNIA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOAESTHESIA ORAL
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INTESTINAL POLYP
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LIP DRY
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LIP PAIN
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUCOUS STOOLS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events3 affected6 at risk
EG0021 events1 affected2 at risk
EG003
ODYNOPHAGIA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected2 at risk
EG003
OESOPHAGEAL PAIN
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OESOPHAGITIS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORAL DISCOMFORT
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORAL DYSAESTHESIA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORAL MUCOSAL BLISTERING
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORAL TOXICITY
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PERIANAL ERYTHEMA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PROCTALGIA
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RECTAL FISSURE
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0002 events2 affected6 at risk
EG0017 events3 affected6 at risk
EG0021 events1 affected2 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected2 at risk
EG003
ASTHENIA
General disorders
MedDRA 14-15
Systematic Assessment
EG0008 events5 affected6 at risk
EG00111 events6 affected6 at risk
EG0022 events2 affected2 at risk
EG003
AXILLARY PAIN
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CATHETER SITE ERYTHEMA
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CATHETER SITE HAEMATOMA
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CATHETER SITE INFLAMMATION
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CATHETER SITE PAIN
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CHEST PAIN
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CHILLS
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DISCOMFORT
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FACE OEDEMA
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FATIGUE
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FEELING COLD
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INFUSION SITE DISCOMFORT
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
IRRITABILITY
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MALAISE
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUCOSAL DRYNESS
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NODULE
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OEDEMA
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 14-15
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PAIN
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PYREXIA
General disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SPINAL PAIN
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
XEROSIS
General disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GALLBLADDER PAIN
Hepatobiliary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HEPATOTOXICITY
Hepatobiliary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ABSCESS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BACTERIAL INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CANDIDIASIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CONJUNCTIVITIS BACTERIAL
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CONJUNCTIVITIS INFECTIVE
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0014 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DERMATOPHYTOSIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DEVICE RELATED SEPSIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FURUNCLE
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HERPES VIRUS INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HORDEOLUM
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LOCALISED INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NAIL BED INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ONYCHOMYCOSIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORAL PUSTULE
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PARONYCHIA
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PHARYNGOTONSILLITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RASH PUSTULAR
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0003 events3 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected2 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TINEA PEDIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TRACHEITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VAGINAL INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VULVITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VULVOVAGINAL CANDIDIASIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ARTHROPOD STING
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ESCHAR
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
POST PROCEDURAL COMPLICATION
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RECALL PHENOMENON
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN INJURY
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TOOTH FRACTURE
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
WOUND
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
WOUND DEHISCENCE
Injury, poisoning and procedural complications
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BLOOD CHOLESTEROL INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BLOOD POTASSIUM DECREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CAPILLARY FRAGILITY TEST
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ELECTROCARDIOGRAM CHANGE
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ELECTROCARDIOGRAM QT PROLONGED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LIVER FUNCTION TEST ABNORMAL
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PULMONARY PHYSICAL EXAMINATION ABNORMAL
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TRANSAMINASES INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
URINE COLOUR ABNORMAL
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERCHOLESTEROLAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BURSITIS
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LIMB DISCOMFORT
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUSCLE CONTRACTURE
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUSCLE RIGIDITY
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OSTEONECROSIS OF JAW
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PAIN IN JAW
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PATHOLOGICAL FRACTURE
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SENSATION OF HEAVINESS
Musculoskeletal and connective tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
UTERINE LEIOMYOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
AGEUSIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
AMNESIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ANOSMIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
APHASIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
APHONIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ATAXIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
COGNITIVE DISORDER
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0002 events2 affected6 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSAESTHESIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSARTHRIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FACIAL NEURALGIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOGEUSIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOKINESIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOSMIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MIGRAINE WITH AURA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MOTOR DYSFUNCTION
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NEURALGIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
POLYNEUROPATHY
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RESTLESS LEGS SYNDROME
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TREMOR
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
AFFECT LABILITY
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
APATHY
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BRADYPHRENIA
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DEPRESSED MOOD
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MOOD ALTERED
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NERVOUSNESS
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RESTLESSNESS
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SLEEP DISORDER
Psychiatric disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BLADDER PAIN
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CYSTITIS HAEMORRHAGIC
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PYURIA
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RENAL FAILURE ACUTE
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BREAST DISCHARGE
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BREAST ENGORGEMENT
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BREAST HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BREAST INFLAMMATION
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BREAST PAIN
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GENITAL DISCHARGE
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
GENITAL RASH
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VAGINAL INFLAMMATION
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VULVAL ULCERATION
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VULVOVAGINAL BURNING SENSATION
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VULVOVAGINAL PRURITUS
Reproductive system and breast disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BRONCHOPNEUMOPATHY
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0003 events2 affected6 at risk
EG0013 events2 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0005 events3 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected2 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0002 events2 affected6 at risk
EG0014 events3 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPEROXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NASAL DISCOMFORT
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NASAL DRYNESS
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NASAL MUCOSAL DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NASAL OBSTRUCTION
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OBSTRUCTIVE AIRWAYS DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OROPHARYNGEAL DISCOMFORT
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PLEURITIC PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RHINALGIA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
THROAT IRRITATION
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
UPPER AIRWAY OBSTRUCTION
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0002 events2 affected6 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DERMAL CYST
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DERMATITIS ALLERGIC
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DRUG ERUPTION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
EXFOLIATIVE RASH
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HEAT RASH
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INGROWING NAIL
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INTERTRIGO
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
MADAROSIS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NAIL DISCOLOURATION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NAIL DISORDER
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0014 events3 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NAIL DYSTROPHY
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NAIL PIGMENTATION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ONYCHOCLASIS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ONYCHOLYSIS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ONYCHOMADESIS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PHOTOSENSITIVITY REACTION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0014 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PRURITUS GENERALISED
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PURPURA
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0005 events3 affected6 at risk
EG00119 events5 affected6 at risk
EG0021 events1 affected2 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RASH GENERALISED
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN CHAPPED
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN DISORDER
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN EXFOLIATION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN FISSURES
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN HYPERPIGMENTATION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN IRRITATION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN PLAQUE
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN REACTION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN STRIAE
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN TOXICITY
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SWELLING FACE
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TELANGIECTASIA
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TOXIC SKIN ERUPTION
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FLUSHING
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HAEMORRHAGE
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERAEMIA
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LYMPHOEDEMA
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ORTHOSTATIC HYPOTENSION
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
PHLEBITIS
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VASCULITIS
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LEFT VENTRICULAR DYSFUNCTION
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TINNITUS
Ear and labyrinth disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
SOFT TISSUE INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TINEA INFECTION
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
URETERITIS
Infections and infestations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0002 events2 affected6 at risk
EG0013 events2 affected6 at risk
EG0022 events1 affected2 at risk
EG003
FLUID RETENTION
Metabolism and nutrition disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DISTURBANCE IN ATTENTION
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
NEUROTOXICITY
Nervous system disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events4 affected6 at risk
EG0020 events0 affected2 at risk
EG003
INCONTINENCE
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
LEUKOCYTURIA
Renal and urinary disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DERMATOSIS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected2 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected2 at risk
EG003
VARICOSE VEIN
Vascular disorders
MedDRA 14-15
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected2 at risk
EG003
The primary statistical analysis of PFS was performed, but the planned analyses of overall survival at 50% maturity, and of PFS at 50% OS maturity, were not performed.
AEs were coded using MedDRA v14.0 (part A) and MedDRA v15.0 (part B).
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Dr Serban Ghiorghiu
Astrazeneca
ClinicalTrialTransparency@astrazeneca.com
ID
Term
D009369
Neoplasms
D001943
Breast Neoplasms
D009362
Neoplasm Metastasis
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D009385
Neoplastic Processes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C548875
AZD 8931
D017239
Paclitaxel
Ancestor Terms
ID
Term
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0052 subjects
0 subjects
FG0050 subjects
28 subjects
FG00524 subjects
54.8
± 11.07
BG004NA± NATreatment in Part B only
BG005NA± NATreatment in Part B only
BG00652.6± 10.63
Age for Part B
Title
Measurements
BG000NA± NATreatment in Part A only
BG001NA± NATreatment in Part A only
BG002NA± NATreatment in Part A only
BG003NA± NATreatment in Part A only
BG00454.5± 11.87
BG00553.1± 10.64
BG00653.8± 11.26
BG002
NA
Customized age tables were not presented for Part A
BG003NACustomized age tables were not presented for Part A
BG00472
BG00584
BG006NATotal not calculated because data are not available (NA) in one or more arms.
> 65 years
Title
Measurements
BG000NACustomized age tables were not presented for Part A
BG001NACustomized age tables were not presented for Part A
BG002NACustomized age tables were not presented for Part A
BG003NACustomized age tables were not presented for Part A
BG00422
BG00512
BG006NATotal not calculated because data are not available (NA) in one or more arms.
18 - <50 years
Title
Measurements
BG000NACustomized age tables were not presented for Part A
BG001NACustomized age tables were not presented for Part A
BG002NACustomized age tables were not presented for Part A
BG003NACustomized age tables were not presented for Part A
BG00434
BG00538
BG006NATotal not calculated because data are not available (NA) in one or more arms.
50 - <=65 years
Title
Measurements
BG000NACustomized age tables were not presented for Part A
BG001NACustomized age tables were not presented for Part A
BG002NACustomized age tables were not presented for Part A
BG003NACustomized age tables were not presented for Part A
BG00438
BG00546
BG006NATotal not calculated because data are not available (NA) in one or more arms.
>65 - <75 years
Title
Measurements
BG000NACustomized age tables were not presented for Part A
BG001NACustomized age tables were not presented for Part A
BG002NACustomized age tables were not presented for Part A
BG003NACustomized age tables were not presented for Part A
BG00418
BG00511
BG006NATotal not calculated because data are not available (NA) in one or more arms.
>= 75 years
Title
Measurements
BG000NACustomized age tables were not presented for Part A
BG001NACustomized age tables were not presented for Part A
BG002NACustomized age tables were not presented for Part A
BG003NACustomized age tables were not presented for Part A
BG0044
BG0051
BG006NATotal not calculated because data are not available (NA) in one or more arms.
5
BG0034
BG00494
BG00596
BG006206
Male
BG0001
BG0010
BG0021
BG0032
BG0040
BG0050
BG0064
0
BG0030
BG0042
BG0052
BG0064
Race: Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
Race: Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0044
BG0051
BG0065
Race: Native Haiwaiian or other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Race: White
Title
Measurements
BG0006
BG0012
BG0026
BG0036
BG00475
BG00574
BG006169
Race: Other
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG00413
BG00518
BG00631
Race: Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
6
BG0036
BG00435
BG00531
BG00686
Ethnicity: Native American
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Ethnicity: Native Alaskan/Inuit
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Ethnicity: Native Hawaiian/Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Ethnicity: African
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Ethnicity: African-American
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Ethnicity: African-Caribbean
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
Ethnicity: Asian (other than Chinese and Japanese)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
Ethnicity: Chinese
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Ethnicity: Japanese
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Ethnicity: Not Applicable
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG00447
BG00549
BG00696
Ethnicity: Other
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG00412
BG00514
BG00626
Ethnicity: Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG002NANot applicable for Part A
BG003NANot applicable for Part A
BG00420
BG00521
BG006NATotal not calculated because data are not available (NA) in one or more arms.
Prior taxane: No
Title
Measurements
BG000NANot applicable for Part A
BG001NANot applicable for Part A
BG002NANot applicable for Part A
BG003NANot applicable for Part A
BG00474
BG00575
BG006NATotal not calculated because data are not available (NA) in one or more arms.
Not applicable for Part A
BG002NANot applicable for Part A
BG003NANot applicable for Part A
BG00476
BG00575
BG006NATotal not calculated because data are not available (NA) in one or more arms.
Hormone receptor status Negative [ER-/PgR-]
Title
Measurements
BG000NANot applicable for Part A
BG001NANot applicable for Part A
BG002NANot applicable for Part A
BG003NANot applicable for Part A
BG00418
BG00521
BG006NATotal not calculated because data are not available (NA) in one or more arms.
NA
Not applicable for Part A
BG002NANot applicable for Part A
BG003NANot applicable for Part A
BG00415
BG00518
BG006NATotal not calculated because data are not available (NA) in one or more arms.
Prior chemotherapy: No
Title
Measurements
BG000NANot applicable for Part A
BG001NANot applicable for Part A
BG002NANot applicable for Part A
BG003NANot applicable for Part A
BG00479
BG00578
BG006NATotal not calculated because data are not available (NA) in one or more arms.
6
0
Eye disorders: Keratitis
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Eye disorders: Photophobia
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Gastrointestinal disorders: Diarrhoea
Title
Measurements
OG0001
OG0011
OG0020
OG0030
Gastrointestinal disorders: Oesophagitis
Title
Measurements
OG0000
OG0010
OG0021
OG0030
Infections and infestations: Rash pustular
Title
Measurements
OG0000
OG0010
OG0021
OG0030
No
Superiority or Other
94
OG00196
events
OG00069
OG00168
Title
Denominators
Categories
Title
Measurements
OG0008.7(4.2 to 12.9)
OG0019.1(3.4 to 14.8)
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
OG001
Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.
Cox Proportional Hazard model
Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test
0.679
Statistical significance threshold at this analysis was 5%
Hazard Ratio (HR)
1.08
2-Sided
95
0.76
1.52
The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio <1 favours AZD8931 40mg + paclitaxel
No
Superiority or Other
Units
Counts
Participants
OG00088
OG00185
Title
Denominators
Categories
Total
Title
Measurements
OG00052(4.2 to 12.9)
OG00135(3.4 to 14.8)
Complete Response
Title
Measurements
OG00011
OG0016
Partial Response
Title
Measurements
OG00041
OG00129
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
OG001
Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.
Logistic Regression
Logistic reg. model with terms for treatment, prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test
0.026
Statistical significance threshold at this analysis was 5%
Odds Ratio (OR)
2.02
2-Sided
95
1.09
3.75
The odds Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a odds ratio <1 favours AZD8931 40mg + paclitaxel
No
Superiority or Other
94
OG00196
events
OG00028
OG00124
Title
Denominators
Categories
Title
Measurements
OG000NA(13.1 to NA)Median and the upper limit of the inter-quartile range for both treatment groups are not calculable due to an insufficient number of events
OG001NA(14.1 to NA)Median and the upper limit of the inter-quartile range for both treatment groups are not calculable due to an insufficient number of events
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
OG001
Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.
Cox proportional hazard model
Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer
0.607
Statistical significance threshold at this analysis was 5%
Hazard Ratio (HR)
1.15
2-Sided
95
0.67
2.01
The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio <1 favours AZD8931 40mg + paclitaxel