Investigating Safety, Tolerability and Efficacy of AZD536... | NCT01625286 | Trialant
NCT01625286
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Jan 18, 2023Actual
Enrollment
148Actual
Phase
Phase 1Phase 2
Conditions
Advanced or Metastatic Breast Cancer
ER+ve Advanced or Metastatic Breast Cancer
Interventions
AZD5363 when combined with weekly paclitaxel.
AZD5363 when combined with weekly paclitaxel.
AZD5363when combined with weekly paclitaxel.
A placebo in combination with weekly paclitaxel.
Countries
Bulgaria
Canada
Czechia
France
Japan
Mexico
Peru
Singapore
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01625286
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D3610C00002
Secondary IDs
ID
Type
Description
Link
2011-006312-31
EudraCT Number
Brief Title
Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients
Official Title
A Phase I/II Study of AZD5363 Combined With Paclitaxel in Patients With Advanced or Metastatic Breast Cancer. Comprising a Safety Run-In and a Placebo-controlled Randomised Expansion in ER+ve Patients Stratified by PIK3CA Mutation Status
Acronym
BEECH
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Dec 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 3, 2012Actual
Primary Completion Date
Jan 28, 2017Actual
Completion Date
Oct 3, 2022Actual
First Submitted Date
May 10, 2012
First Submission Date that Met QC Criteria
Jun 19, 2012
First Posted Date
Jun 21, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 25, 2018
Results First Submitted that Met QC Criteria
Jan 2, 2019
Results First Posted Date
Apr 1, 2019Actual
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
Dec 23, 2022
Last Update Posted Date
Jan 18, 2023Actual
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 purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer, including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) tumour mutation.
Detailed Description
This is a Phase I/II multicentre, study investigating the safety, tolerability and efficacy of a twice-daily oral formulation of AZD5363 when combined with a weekly intravenous paclitaxel infusion in patients with advanced or metastatic breast cancer. Study treatment is given in 28-day cycles, comprising three weeks on-therapy followed by one week off-therapy.
The study will be conducted in two parts:
Part A. Approximately 40 patients will be recruited to this Phase I multiple ascending-dose safety run-in evaluation of each of two intermittent dosing schedules (2 days per week or 4 days per week) of AZD5363 given in combination with weekly paclitaxel. The study population is female patients, 18 years or older, with advanced or metastatic breast cancer.
The purpose of Part A is to assess the comparative safety, tolerability, pharmacokinetics and preliminary efficacy of both schedules to determine one dose and schedule of AZD5363 to take forward to study Part B in combination with weekly paclitaxel.
Part A assessments will be made in dose-escalating cohorts of 3 to 6 patients to determine a recommended dose in each of the schedules. A total of 6 patients must be evaluated at a selected dose level for it to be confirmed as the recommended dose. All dose evaluations and recommendations will be conducted by a Safety Review Committee.
Part A Patients will undergo assessments up to to withdrawal from the study or to discontinuation of study therapy.
Part B. A minimum of 100 patients will be recruited to this Phase II double-blind, placebo-controlled, stratified and randomised evaluation of two treatment regimens: AZD5363 (at a dose selected and schedule from Part A) in combination with weekly paclitaxel vs. weekly paclitaxel plus placebo. The study population is female patients with Estrogen Receptor Positive advanced or metastatic breast cancer; of which approximately 50 will have the phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) mutation.
Part B patients will be stratified by PIK3CA tumour mutation status as: tumour mutation positive or tumour mutation not-detected. Under each stratum patients will be randomised to receive either paclitaxel + AZD5363 or paclitaxel + placebo.
The purpose of Part B is to assess relative efficacy of both active and placebo regimens by comparison of: progression-free survival, overall survival, tumour response, safety and tolerability in the overall ER+ve advanced or metastatic breast cancer population, and in a subgroup of these patients with the PIK3CA tumour mutation. Patient safety and therapy tolerability will be monitored by an independent Safety Review Committee throuighout the course of Part B.
Part B patients will be followed for assessment of overall survival, or to withdrawal from the study.
Conditions Module
Conditions
Advanced or Metastatic Breast Cancer
ER+ve Advanced or Metastatic Breast Cancer
Keywords
advanced breast cancer,
metastatic breast cancer,
ER+ve breast cancer,
Estrogen receptor positive breast cancer,
PIK3CA mutated advanced or metastatic breast cancer
AKT inhibitor
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
148Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Intermittent schedule (2/5)
Experimental
See intervention description below.
Drug: AZD5363 when combined with weekly paclitaxel.
Part A: Intermittent schedule (4/3)
Experimental
See intervention description below.
Drug: AZD5363 when combined with weekly paclitaxel.
Part B: AZD5363 combined with paclitaxel
Active Comparator
See intervention description below.
Drug: AZD5363when combined with weekly paclitaxel.
Part B: paclitaxel combined with placebo
Placebo Comparator
See intervention description below.
Drug: A placebo in combination with weekly paclitaxel.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD5363 when combined with weekly paclitaxel.
Drug
AZD5363: oral capsule, twice daily in a weekly 2 days on-treatment, 5 days-off, schedule. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose-limiting Toxicity (DLT) Events - Part A
An Adverse Event (AE) or laboratory abnormality considered to be related to study drug, that starts at any time during the DLT evaluation period (Cycle 1) and is dose limiting
During Part A DLT evaluation period (Cycle 1, up to 28 days)
Progression Free Survival (PFS) - Part B
Time from randomisation to date of objective disease progression or death (by any cause in the absence of progression). Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a >= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, and an absolute increase of >=5mm, or progression of non-target lesions or the appearance of new lesions.
From randomisation date to date of objective disease progression or death (by any cause) whichever came first, assessed every 12 wks (median total treatment duration AZD5363=325.5 days; Placebo=245 days)
Secondary Outcomes
Measure
Description
Time Frame
Change in Tumour Size at 12 Weeks
Percentage change from baseline to week 12 in sum of longest diameters of target lesions as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). Based on patients with measurable disease who had sufficient data available to either calculate or impute a change at 12 weeks
RECIST tumour assessments every 12 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent.
Female patient.
Aged at least 18 years.
Histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be ER+ve, HER2-ve, in Part B).
World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
Exclusion Criteria:
Clinically significant abnormalities of glucose metabolism.
Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
Any prior exposure to agents which inhibit AKT as the primary pharmacological activity.
Part A: more than two prior courses of chemotherapy (including taxanes) for advanced or metastatic breast cancer.
Part B: any prior chemotherapy for advanced or metastatic breast cancer.
Hrebien S, Citi V, Garcia-Murillas I, Cutts R, Fenwick K, Kozarewa I, McEwen R, Ratnayake J, Maudsley R, Carr TH, de Bruin EC, Schiavon G, Oliveira M, Turner N. Early ctDNA dynamics as a surrogate for progression-free survival in advanced breast cancer in the BEECH trial. Ann Oncol. 2019 Jun 1;30(6):945-952. doi: 10.1093/annonc/mdz085.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
AZD5363: oral capsule, twice daily in a weekly 4 days on-treatment, 3 days-off, schedule. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
Part A: Intermittent schedule (4/3)
AZD5363when combined with weekly paclitaxel.
Drug
Either a 2/5 or 3/4 intermittent dosing schedule of AZD5363 based on the outcome of Part A. Dosage: oral formulation, twice daily. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
Part B: AZD5363 combined with paclitaxel
A placebo in combination with weekly paclitaxel.
Drug
Either a 2/5 or 3/4 intermittent dosing schedule of placebo matched to AZD5363 based on the outcome of Part A. Dosage: oral formulation, twice daily. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. placebo and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
Part B: paclitaxel combined with placebo
Objective Response Rate (ORR) at Week 12
Percentage of patients who have at least one visit response of Complete Response or Partial Response prior to any evidence of progression at week 12 as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm; Objective Response Rate (ORR) = CR + PR
RECIST tumour assessments every 12 weeks
Best Objective Response (BOR)
Number of patients, taking their BOR, which is their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.
From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Overall Objective Response Rate
Percentage of patients, taking their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm. Overall Response Rate (ORR) = CR + PR
From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Number of Subjects Without Progression Disease at Week 12 - Part A
Percentage of patients with a 12 week visit response of CR, PR or SD (as defined by RECIST 1.1) with no evidence of previous progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.
up to 12 weeks
Duration of Response (DOR) - Part B
Date of first documentation of response (Complete Response/Partial Response) until the date of disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.. If a subject does not progress following a response, then their DOR will use the PFS censoring time.
From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Durable Response Rate (DRR) - Part B
Percentage of patients who have a Complete Response (CR) or Partial Response (PR) lasting continuously for at least 24 weeks as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: PR, >=30% decrease in the sum of the longest diameter of target lesions; CR, disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.
From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Overall Survival - Part B
The interval between the date of randomisation and the date of patient death due to any cause. All Part B patients were analysed, number of deaths is presented.
From date of randomisation, assessed every 12 weeks, up until the time of final statistical analysis. (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Sofia
1330
Bulgaria
Research Site
Calgary
Alberta
T2N 4N2
Canada
Research Site
Ottawa
Ontario
K1H 8L6
Canada
Research Site
Montreal
Quebec
H4A 3T2
Canada
Research Site
Québec
Quebec
G1S 4L8
Canada
Research Site
Brno
656 53
Czechia
Research Site
Paris
75248
France
Research Site
Pierre-Bénite
69310
France
Research Site
Villejuif
94805
France
Research Site
Chiba
260-8717
Japan
Research Site
Chūōku
104-0045
Japan
Research Site
Fukuoka
811-1395
Japan
Research Site
Mitaka-shi
181-8611
Japan
Research Site
Osaka
540-0006
Japan
Research Site
Ōita
870-0854
Japan
Research Site
Estado de México
50080
Mexico
Research Site
Juchitán
7000
Mexico
Research Site
Monterrey
64460
Mexico
Research Site
Oaxaca City
68000
Mexico
Research Site
Lima
15036
Peru
Research Site
Lima
L 41
Peru
Research Site
Lima
LIMA 27
Peru
Research Site
Miraflores
15046
Peru
Research Site
Singapore
119228
Singapore
Research Site
Seongnam-si
13620
South Korea
Research Site
Seoul
03080
South Korea
Research Site
Seoul
03722
South Korea
Research Site
Seoul
135-710
South Korea
Research Site
Barcelona
08025
Spain
Research Site
Madrid
08035
Spain
Research Site
Madrid
28040
Spain
Research Site
Madrid
28041
Spain
Research Site
Málaga
29010
Spain
Research Site
Valencia
46010
Spain
Research Site
Glasgow
G12 0YN
United Kingdom
Research Site
Leicester
LE1 5WW
United Kingdom
Research Site
London
SW3 6JJ
United Kingdom
Research Site
Manchester
M20 4BX
United Kingdom
Research Site
Plymouth
PL6 8DH.
United Kingdom
Research Site
Sutton
SM2 5PT
United Kingdom
Derived
Turner NC, Alarcon E, Armstrong AC, Philco M, Lopez Chuken YA, Sablin MP, Tamura K, Gomez Villanueva A, Perez-Fidalgo JA, Cheung SYA, Corcoran C, Cullberg M, Davies BR, de Bruin EC, Foxley A, Lindemann JPO, Maudsley R, Moschetta M, Outhwaite E, Pass M, Rugman P, Schiavon G, Oliveira M. BEECH: a dose-finding run-in followed by a randomised phase II study assessing the efficacy of AKT inhibitor capivasertib (AZD5363) combined with paclitaxel in patients with estrogen receptor-positive advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population. Ann Oncol. 2019 May 1;30(5):774-780. doi: 10.1093/annonc/mdz086.
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
FG003
Part A Schedule 2 400 mg bd
Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
FG004
Part A Schedule 2 480 mg bd
Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
FG005
Part B AZD5363
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
FG006
Part B Placebo
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
FG00012 subjects
FG0018 subjects
FG0025 subjects
FG0037 subjects
FG0046 subjects
FG00554 subjects
FG00656 subjects
Received AZD5363/Placebo Treatment
FG00012 subjects
FG0018 subjects
FG0025 subjects
FG0037 subjects
FG0046 subjects
FG00554 subjects
FG00655 subjects
Did Not Receive AZD5363/Placebo Trt
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
COMPLETED
Completed Study includes patients who were on study or treatment at the final database lock for primary analysis
FG0006 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00540 subjects
FG00637 subjects
NOT COMPLETED
FG0006 subjects
FG0014 subjects
FG0025 subjects
FG0037 subjects
FG0046 subjects
FG00514 subjects
FG00619 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Any reason not specifically recorded
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive disease
FG0006 subjects
FG0013 subjects
FG0024 subjects
FG0035 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All patients with data who were included in the full analysis set for Part A and the intention to treat analysis set in Part B'
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
BG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
BG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
BG003
Part A Schedule 2 400 mg bd
Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
BG004
Part A Schedule 2 480 mg bd
Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
BG005
Part B AZD5363
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
BG006
Part B Placebo
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG0018
BG0025
BG0037
BG0046
BG00554
BG00656
BG007148
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00052.2± 9.92
BG00158.8± 12.78
BG00256.6± 10.26
BG003
Age, Customized
For Part A Schedule 2 400 mg bd, there were no participants aged >=65
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<50
BG0005
BG0013
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG0018
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Dose-limiting Toxicity (DLT) Events - Part A
An Adverse Event (AE) or laboratory abnormality considered to be related to study drug, that starts at any time during the DLT evaluation period (Cycle 1) and is dose limiting
All Part A patients who either completed the DLT evaluation period with at least 80% of specified dose (of AZD5363 or paxlitaxel) or who experienced a DLT. DLT events were not assessed for Part B participants.
Posted
Number
participants
During Part A DLT evaluation period (Cycle 1, up to 28 days)
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG003
Part A Schedule 2 400 mg bd
Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG004
Part A Schedule 2 480 mg bd
Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG005
Part B AZD5363
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
OG006
Part B Placebo
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Units
Counts
Participants
OG00011
OG0016
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0020
OG003
Primary
Progression Free Survival (PFS) - Part B
Time from randomisation to date of objective disease progression or death (by any cause in the absence of progression). Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a >= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, and an absolute increase of >=5mm, or progression of non-target lesions or the appearance of new lesions.
Intent to Treat (ITT), all randomised patients
Posted
Median
95% Confidence Interval
Months
From randomisation date to date of objective disease progression or death (by any cause) whichever came first, assessed every 12 wks (median total treatment duration AZD5363=325.5 days; Placebo=245 days)
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
Secondary
Change in Tumour Size at 12 Weeks
Percentage change from baseline to week 12 in sum of longest diameters of target lesions as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). Based on patients with measurable disease who had sufficient data available to either calculate or impute a change at 12 weeks
Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)
Posted
Mean
Standard Deviation
% change from baseline
RECIST tumour assessments every 12 weeks
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG003
Part A Schedule 2 400 mg bd
Secondary
Objective Response Rate (ORR) at Week 12
Percentage of patients who have at least one visit response of Complete Response or Partial Response prior to any evidence of progression at week 12 as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm; Objective Response Rate (ORR) = CR + PR
Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)
Posted
Number
% of participants
RECIST tumour assessments every 12 weeks
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
Secondary
Best Objective Response (BOR)
Number of patients, taking their BOR, which is their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.
Posted
Number
Participants
From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG003
Secondary
Overall Objective Response Rate
Percentage of patients, taking their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm. Overall Response Rate (ORR) = CR + PR
Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)
Posted
Number
% of participants
From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
Secondary
Number of Subjects Without Progression Disease at Week 12 - Part A
Percentage of patients with a 12 week visit response of CR, PR or SD (as defined by RECIST 1.1) with no evidence of previous progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.
Part A Full Analysis Set (FAS). Not recorded in Part B.
Posted
Count of Participants
Participants
up to 12 weeks
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
Secondary
Duration of Response (DOR) - Part B
Date of first documentation of response (Complete Response/Partial Response) until the date of disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.. If a subject does not progress following a response, then their DOR will use the PFS censoring time.
Part B, all patients with a response in the ITT analysis set. Not collected in Part A
Posted
Median
95% Confidence Interval
Months
From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Secondary
Durable Response Rate (DRR) - Part B
Percentage of patients who have a Complete Response (CR) or Partial Response (PR) lasting continuously for at least 24 weeks as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: PR, >=30% decrease in the sum of the longest diameter of target lesions; CR, disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.
Part B, ITT analysis set. Not collected in Part A
Posted
Number
% of participants
From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
Secondary
Overall Survival - Part B
The interval between the date of randomisation and the date of patient death due to any cause. All Part B patients were analysed, number of deaths is presented.
Part B Intent to Treat (ITT). Not collected in Part A
Posted
Median
95% Confidence Interval
months
From date of randomisation, assessed every 12 weeks, up until the time of final statistical analysis. (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
ID
Title
Description
OG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG001
Part A Schedule 1 640 mg bd
Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG002
Part A Schedule 2 360 mg bd
Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
OG003
Part A Schedule 2 400 mg bd
Time Frame
Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months)
Description
The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A Schedule 1 560 mg bd
Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
0
12
3
12
12
12
EG001
Sched 1 - AZD5363 640 mg bd
(2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
0
8
3
8
8
8
EG002
Sched 2 - AZD5363 360 mg bd
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
1
5
0
5
5
5
EG003
Sched 2 - AZD5363 400 mg bd
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
1
7
1
7
7
7
EG004
Part A Schedule 2 480 mg bd
Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.
0
6
4
6
6
6
EG005
Part B AZD5363
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
13
54
13
54
50
54
EG006
Part B Placebo
(4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
15
56
8
55
48
55
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected54 at risk
EG0060 events0 affected55 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Catheter site cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Device related infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Salivary gland cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected7 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected54 at risk
EG0060 events0 affected55 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0024 events2 affected5 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0023 events2 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0024 events2 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG00231 events5 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0028 events1 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events1 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0028 events3 affected5 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 18.0, 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0023 events2 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0024 events1 affected5 at risk
EG003
Device breakage
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0024 events2 affected5 at risk
EG003
Malaise
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 18.0, 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0023 events3 affected5 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 18.0, 20.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 18.0, 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Transaminases increased
Investigations
MedDRA 18.0, 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0026 events1 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events1 affected5 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 18.0, 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Breast discharge
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0023 events3 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0024 events3 affected5 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected5 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 18.0, 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Cystitis
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Paronychia
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0019 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0015 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Flushing
Vascular disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG00017 events6 affected12 at risk
EG00116 events4 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG00020 events3 affected12 at risk
EG00123 events3 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0014 events3 affected8 at risk
EG0021 events1 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0014 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0005 events4 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00066 events11 affected12 at risk
EG00157 events7 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0003 events2 affected12 at risk
EG0015 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00017 events4 affected12 at risk
EG0016 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 20.0
Systematic Assessment
EG00012 events6 affected12 at risk
EG00122 events5 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events3 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Suprapubic pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Influenza
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0004 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Varicella
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0006 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood glucose increased
Investigations
MedDRA 19.1, 20.0
Systematic Assessment
EG0005 events3 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Thyroxine decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0008 events4 affected12 at risk
EG0013 events3 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG00039 events5 affected12 at risk
EG00115 events3 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0003 events2 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0005 events4 affected12 at risk
EG0014 events3 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0015 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0005 events3 affected12 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0004 events3 affected12 at risk
EG0017 events5 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0007 events2 affected12 at risk
EG0014 events4 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Migraine
Nervous system disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG00013 events4 affected12 at risk
EG0017 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0006 events5 affected12 at risk
EG0013 events3 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Radicular pain
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0002 events1 affected12 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0003 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0006 events5 affected12 at risk
EG0014 events3 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0003 events2 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0004 events3 affected12 at risk
EG0014 events3 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0006 events3 affected12 at risk
EG0014 events4 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Melanoderma
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA 19.1, 20.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0005 events2 affected12 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0, 20.0
Systematic Assessment
EG0002 events1 affected12 at risk
EG0015 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0005 events2 affected12 at risk
EG0013 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00023 events8 affected12 at risk
EG0016 events5 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Normochromic normocytic anaemia
Blood and lymphatic system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Ear canal erythema
Ear and labyrinth disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Photopsia
Eye disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Catheter site related reaction
General disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Face oedema
General disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Viral infection
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Generalised erythema
Skin and subcutaneous tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Conjunctival pallor
Eye disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hyperthermia
General disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Liver palpable
Investigations
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Calcium deficiency
Metabolism and nutrition disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Cell death
Metabolism and nutrition disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0018 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 18, 19.1, 20
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected5 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA 18.0, 20.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected5 at risk
EG003
QoL, PK/PD & efficacy response modelling were considered non-key secondary endpoints and not disclosed at this time. QoL data was limited and considered exploratory, PK/PD and modelling were not reported in CSR. Diarrhoea burden is reported with AEs