AZD9291 First Time In Patients Ascending Dose Study | NCT01802632 | Trialant
NCT01802632
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Apr 20, 2026Actual
Enrollment
603Actual
Phase
Phase 1Phase 2
Conditions
Advanced Non Small Cell Lung Cancer
Advanced (Inoperable) Non Small Cell Lung Cancer
Interventions
AZD9291
Countries
United States
Australia
France
Germany
Italy
Japan
South Korea
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01802632
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D5160C00001
Secondary IDs
ID
Type
Description
Link
2012-004628-39
EudraCT Number
Brief Title
AZD9291 First Time In Patients Ascending Dose Study
Official Title
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent
Acronym
AURA
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Apr 2026
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
Mar 4, 2013Actual
Primary Completion Date
May 1, 2015Actual
Completion Date
Dec 11, 2023Actual
First Submitted Date
Feb 25, 2013
First Submission Date that Met QC Criteria
Feb 28, 2013
First Posted Date
Mar 1, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 29, 2016
Results First Submitted that Met QC Criteria
Aug 12, 2016
Results First Posted Date
Oct 6, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 16, 2026
Last Update Posted Date
Apr 20, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.
Detailed Description
A Phase I/II, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of AZD9291 in Patients with Advanced Non Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (AURA)
Conditions Module
Conditions
Advanced Non Small Cell Lung Cancer
Advanced (Inoperable) Non Small Cell Lung Cancer
Keywords
Oncology,
Non Small Cell Lung Cancer,
Metastatic,
EGFR sensitivity mutation,
T790M resistance mutation
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
603Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Daily dose of AZD9291
Experimental
Daily oral dose of AZD9291
Drug: AZD9291
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD9291
Drug
Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) for Dose Expansion Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
Best Objective Response (BOR) for Dose Escalation Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)
Objective Response Rate (ORR) for Extension Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DoR) for Dose Expansion Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
Aged at least 18 years. Patients from Japan aged at least 20 years.
Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).
Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib (with the exception of 1st line expansion cohort). In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
Patients (with the exception of 1st line expansion cohort) must fulfil one of the following:
Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR
Must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria (Jackman et al 2010) followed by systemic objective progression (RECIST or WHO) while on continuous treatment with EGFR TKI.
Previous treatment with a single-agent EGFR TKI (e.g. gefitinib or erlotinib).
Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.
Male patients should be willing to use barrier contraception.
For 1st Line expansion cohort ONLY, confirmation that the tumour is EGFRm+ve and have had no prior therapy for their advanced disease (for 1st line patients biopsy will be at time of diagnosis of advanced disease).
For dose expansion and extension cohorts, patients must also have confirmation of tumour T790M mutation status (confirmed positive or negative) from a biopsy sample taken after disease progression on the most recent treatment regimen (irrespective of whether this is EGFR TKI or chemotherapy).
Prior to entry a result from the central analysis of the patient's T790M mutation status must be obtained.
- World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Exclusion Criteria:
Treatment with an EGFR TKI (erlotinib or gefitinib) within 8 days (approximately 5x half-life) of the first dose of study treatment.
Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
AZD9291 in the present study (ie, dosing with AZD9291 previously initiated in this study).
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection.
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.
Martin ML, Correll J, Walding A, Ryden A. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects. Qual Life Res. 2022 Jan;31(1):135-146. doi: 10.1007/s11136-021-02882-6. Epub 2021 May 31.
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: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
When a request has been approved AstraZeneca will provide access to the de-identified 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.
603 patients were enrolled and received treatment.
Recruitment Details
Patients recruited to different cohorts. Dose escalation cohort of pre-treated patients in 5 dose groups. Dose expansion cohort (pre-treated) in same 5 dose groups. First line patient cohort. 80mg tablet cohort of pre-treated patients. Japan-only cohort (EGFR T790M+ by cytology). Phase II extension cohort in pre-treated EGFR T790M+ patients.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AZD9291 80mg Extension
Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
FG001
Dose Escalation
Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Daily dose of AZD9291
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
Progression-Free Survival (PFS) for Dose Expansion Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
Best Objective Response (BOR) for 80mg AZD9291 Extension Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)
Ahn MJ, Han JY, Kim DW, Cho BC, Kang JH, Kim SW, Yang JC, Mitsudomi T, Lee JS. Osimertinib in Patients with T790M-Positive Advanced Non-small Cell Lung Cancer: Korean Subgroup Analysis from Phase II Studies. Cancer Res Treat. 2020 Jan;52(1):284-291. doi: 10.4143/crt.2019.200. Epub 2019 Jul 23.
Ahn MJ, Tsai CM, Shepherd FA, Bazhenova L, Sequist LV, Hida T, Yang JCH, Ramalingam SS, Mitsudomi T, Janne PA, Mann H, Cantarini M, Goss G. Osimertinib in patients with T790M mutation-positive, advanced non-small cell lung cancer: Long-term follow-up from a pooled analysis of 2 phase 2 studies. Cancer. 2019 Mar 15;125(6):892-901. doi: 10.1002/cncr.31891. Epub 2018 Dec 4.
Oxnard GR, Hu Y, Mileham KF, Husain H, Costa DB, Tracy P, Feeney N, Sholl LM, Dahlberg SE, Redig AJ, Kwiatkowski DJ, Rabin MS, Paweletz CP, Thress KS, Janne PA. Assessment of Resistance Mechanisms and Clinical Implications in Patients With EGFR T790M-Positive Lung Cancer and Acquired Resistance to Osimertinib. JAMA Oncol. 2018 Nov 1;4(11):1527-1534. doi: 10.1001/jamaoncol.2018.2969.
Kiura K, Yoh K, Katakami N, Nogami N, Kasahara K, Takahashi T, Okamoto I, Cantarini M, Hodge R, Uchida H. Osimertinib in patients with epidermal growth factor receptor T790M advanced non-small cell lung cancer selected using cytology samples. Cancer Sci. 2018 Apr;109(4):1177-1184. doi: 10.1111/cas.13511. Epub 2018 Feb 27.
Goss G, Tsai CM, Shepherd FA, Ahn MJ, Bazhenova L, Crino L, de Marinis F, Felip E, Morabito A, Hodge R, Cantarini M, Johnson M, Mitsudomi T, Janne PA, Yang JC. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two phase II trials. Ann Oncol. 2018 Mar 1;29(3):687-693. doi: 10.1093/annonc/mdx820.
Ramalingam SS, Yang JC, Lee CK, Kurata T, Kim DW, John T, Nogami N, Ohe Y, Mann H, Rukazenkov Y, Ghiorghiu S, Stetson D, Markovets A, Barrett JC, Thress KS, Janne PA. Osimertinib As First-Line Treatment of EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Mar 20;36(9):841-849. doi: 10.1200/JCO.2017.74.7576. Epub 2017 Aug 25.
Thress KS, Jacobs V, Angell HK, Yang JC, Sequist LV, Blackhall F, Su WC, Schuler M, Wolf J, Gold KA, Cantarini M, Barrett JC, Janne PA. Modulation of Biomarker Expression by Osimertinib: Results of the Paired Tumor Biopsy Cohorts of the AURA Phase I Trial. J Thorac Oncol. 2017 Oct;12(10):1588-1594. doi: 10.1016/j.jtho.2017.07.011. Epub 2017 Jul 24.
Ballard P, Yates JW, Yang Z, Kim DW, Yang JC, Cantarini M, Pickup K, Jordan A, Hickey M, Grist M, Box M, Johnstrom P, Varnas K, Malmquist J, Thress KS, Janne PA, Cross D. Preclinical Comparison of Osimertinib with Other EGFR-TKIs in EGFR-Mutant NSCLC Brain Metastases Models, and Early Evidence of Clinical Brain Metastases Activity. Clin Cancer Res. 2016 Oct 15;22(20):5130-5140. doi: 10.1158/1078-0432.CCR-16-0399. Epub 2016 Jul 19.
Oxnard GR, Thress KS, Alden RS, Lawrance R, Paweletz CP, Cantarini M, Yang JC, Barrett JC, Janne PA. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Oct 1;34(28):3375-82. doi: 10.1200/JCO.2016.66.7162. Epub 2016 Jun 27.
Thress KS, Brant R, Carr TH, Dearden S, Jenkins S, Brown H, Hammett T, Cantarini M, Barrett JC. EGFR mutation detection in ctDNA from NSCLC patient plasma: A cross-platform comparison of leading technologies to support the clinical development of AZD9291. Lung Cancer. 2015 Dec;90(3):509-15. doi: 10.1016/j.lungcan.2015.10.004. Epub 2015 Oct 9.
Kim TM, Song A, Kim DW, Kim S, Ahn YO, Keam B, Jeon YK, Lee SH, Chung DH, Heo DS. Mechanisms of Acquired Resistance to AZD9291: A Mutation-Selective, Irreversible EGFR Inhibitor. J Thorac Oncol. 2015 Dec;10(12):1736-44. doi: 10.1097/JTO.0000000000000688.
Yu HA, Tian SK, Drilon AE, Borsu L, Riely GJ, Arcila ME, Ladanyi M. Acquired Resistance of EGFR-Mutant Lung Cancer to a T790M-Specific EGFR Inhibitor: Emergence of a Third Mutation (C797S) in the EGFR Tyrosine Kinase Domain. JAMA Oncol. 2015 Oct;1(7):982-4. doi: 10.1001/jamaoncol.2015.1066. No abstract available.
Janne PA, Yang JC, Kim DW, Planchard D, Ohe Y, Ramalingam SS, Ahn MJ, Kim SW, Su WC, Horn L, Haggstrom D, Felip E, Kim JH, Frewer P, Cantarini M, Brown KH, Dickinson PA, Ghiorghiu S, Ranson M. AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015 Apr 30;372(18):1689-99. doi: 10.1056/NEJMoa1411817.
Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
FG003
First Line
Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
FG004
80mg Tablet
US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
FG005
Japan Cytology
Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
FG000201 subjects
FG00131 subjects
FG002271 subjects
FG00360 subjects
FG00412 subjects
FG00528 subjects
COMPLETED
FG000139 subjects
FG00116 subjects
FG002115 subjects
FG00350 subjects
FG0046 subjects
FG00522 subjects
NOT COMPLETED
FG00062 subjects
FG00115 subjects
FG002156 subjects
FG00310 subjects
FG0046 subjects
FG0056 subjects
Type
Comment
Reasons
Death
FG00054 subjects
FG0011 subjects
FG00238 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
Withdrawal by Subject
FG0008 subjects
FG0012 subjects
FG0027 subjects
FG0033 subjects
FG004
Objective Disease Progression
FG0000 subjects
FG00112 subjects
FG002104 subjects
FG0036 subjects
FG004
Other (not specified)
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AZD9291 80mg Extension
Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
BG001
Dose Escalation
Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
BG002
Dose Expansion
Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
BG003
First Line
Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
BG004
80mg Tablet
US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
BG005
Japan Cytology
Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000201
BG00131
BG002271
BG00360
BG00412
BG00528
BG006603
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
<50 Years
Title
Measurements
BG00030
BG0013
BG00242
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000133
BG00120
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG000114
BG00121
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
Objective Response Rate (ORR) for Dose Expansion Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.
Posted
Number
95% Confidence Interval
% of participants
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
ID
Title
Description
OG000
Dose Expansion
Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
Units
Counts
Participants
OG000175
Title
Denominators
Categories
Title
Measurements
OG00061.7(54.1 to 68.9)
Primary
Best Objective Response (BOR) for Dose Escalation Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.
All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.
Posted
Number
% of participants
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)
ID
Title
Description
OG000
Dose Escalation
Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
Units
Counts
Secondary
Duration of Response (DoR) for Dose Expansion Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).
All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.
Posted
Median
95% Confidence Interval
months
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
ID
Title
Description
OG000
Dose Expansion
Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
Units
Counts
Participants
OG000
Secondary
Progression-Free Survival (PFS) for Dose Expansion Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.
Posted
Median
95% Confidence Interval
months
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
ID
Title
Description
OG000
Dose Expansion
Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
Units
Counts
Participants
Primary
Objective Response Rate (ORR) for Extension Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by independent central review) at baseline.
Posted
Number
95% Confidence Interval
% of participants
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)
ID
Title
Description
OG000
80mg AZD9291 Extension
Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
Units
Counts
Participants
Secondary
Best Objective Response (BOR) for 80mg AZD9291 Extension Population
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.
All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by investigator assessment) at baseline.
Posted
Number
% of participants
RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)
ID
Title
Description
OG000
80mg AZD9291 Extension
Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
Time Frame
AEs from start of study drug until 28 days post study treatment discontinuation, up to approximately 25 months (at time of analysis).
Description
Different cohorts started at different times and so some cohorts have collected AE data for a shorter length of time, e.g. Extension cohort was the last cohort and follow up is approximately 12 months at time of analysis. Systematic assessment due to regular investigator assessment at study visits.
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
AZD9291 80mg Extension
Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
41
201
191
201
EG001
Dose Escalation
Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
9
31
31
31
EG002
Dose Expansion
Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
78
271
265
271
EG003
First Line
Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
14
60
60
60
EG004
80mg Tablet
US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
4
12
12
12
EG005
Japan Cytology
Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
4
28
24
28
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG0030 events0 affected60 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected28 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0011 events1 affected31 at risk
EG0024 events4 affected271 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0013 events2 affected31 at risk
EG0023 events3 affected271 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Asthenia
General disorders and administration site conditions
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Fatigue
General disorders and administration site conditions
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Localised oedema
General disorders and administration site conditions
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Oedema peripheral
General disorders and administration site conditions
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected201 at risk
EG0013 events3 affected31 at risk
EG0028 events8 affected271 at risk
EG003
Salmonella sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Viral infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Metastatic pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected271 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected271 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 events2 affected201 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected271 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected271 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0010 events0 affected31 at risk
EG00213 events10 affected271 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected271 at risk
EG003
General physical health deterioration
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Seizure
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Pulmonary artery thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Pulseless electrical activity
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Corneal erosion
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected271 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Small intestine ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Device related infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Lung infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Mediastinitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Respiratory tract infection bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Septic shock
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Viraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected271 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Brain injury
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Cerebral cyst
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Facial nerve disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Pulmonary granuloma
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Embolism
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Peripheral artery thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 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
EG00022 events18 affected201 at risk
EG0017 events6 affected31 at risk
EG00249 events36 affected271 at risk
EG00310 events9 affected60 at risk
EG0040 events0 affected12 at risk
EG0055 events5 affected28 at risk
Dry eye
Eye disorders
MedDRA 18.0
Systematic Assessment
EG00014 events12 affected201 at risk
EG0013 events3 affected31 at risk
EG00221 events20 affected271 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00013 events12 affected201 at risk
EG0013 events2 affected31 at risk
EG00226 events19 affected271 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00031 events30 affected201 at risk
EG0014 events3 affected31 at risk
EG00265 events60 affected271 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG000147 events93 affected201 at risk
EG00138 events19 affected31 at risk
EG002219 events144 affected271 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00013 events13 affected201 at risk
EG0011 events1 affected31 at risk
EG00218 events17 affected271 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00045 events34 affected201 at risk
EG0019 events8 affected31 at risk
EG00296 events72 affected271 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00028 events27 affected201 at risk
EG00114 events8 affected31 at risk
EG00263 events50 affected271 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00031 events23 affected201 at risk
EG00110 events7 affected31 at risk
EG00273 events48 affected271 at risk
EG003
Asthenia
General disorders and administration site conditions
MedDRA 18.0
Systematic Assessment
EG00034 events19 affected201 at risk
EG0013 events3 affected31 at risk
EG00236 events25 affected271 at risk
EG003
Fatigue
General disorders and administration site conditions
MedDRA 18.0
Systematic Assessment
EG00027 events24 affected201 at risk
EG0016 events5 affected31 at risk
EG00268 events64 affected271 at risk
EG003
Oedema peripheral
General disorders and administration site conditions
MedDRA 18.0
Systematic Assessment
EG00017 events15 affected201 at risk
EG0010 events0 affected31 at risk
EG00222 events20 affected271 at risk
EG003
Pyrexia
General disorders and administration site conditions
MedDRA 18.0
Systematic Assessment
EG00013 events12 affected201 at risk
EG0011 events1 affected31 at risk
EG00228 events27 affected271 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00016 events14 affected201 at risk
EG00110 events6 affected31 at risk
EG00226 events21 affected271 at risk
EG003
Paronychia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00048 events40 affected201 at risk
EG00111 events8 affected31 at risk
EG00275 events64 affected271 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00020 events18 affected201 at risk
EG00115 events6 affected31 at risk
EG00229 events27 affected271 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG00013 events12 affected201 at risk
EG0013 events3 affected31 at risk
EG00223 events16 affected271 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG00018 events14 affected201 at risk
EG0012 events2 affected31 at risk
EG00227 events19 affected271 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG00038 events26 affected201 at risk
EG0011 events1 affected31 at risk
EG00231 events24 affected271 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG00019 events15 affected201 at risk
EG0014 events3 affected31 at risk
EG00220 events8 affected271 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG00041 events36 affected201 at risk
EG00118 events12 affected31 at risk
EG00280 events69 affected271 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00018 events16 affected201 at risk
EG0014 events4 affected31 at risk
EG00233 events26 affected271 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00029 events27 affected201 at risk
EG0016 events3 affected31 at risk
EG00230 events27 affected271 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00014 events13 affected201 at risk
EG0014 events3 affected31 at risk
EG00227 events24 affected271 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00016 events15 affected201 at risk
EG0012 events2 affected31 at risk
EG00220 events20 affected271 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00022 events22 affected201 at risk
EG0017 events4 affected31 at risk
EG00234 events30 affected271 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG00021 events19 affected201 at risk
EG0011 events1 affected31 at risk
EG00228 events27 affected271 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00036 events32 affected201 at risk
EG0014 events4 affected31 at risk
EG00264 events55 affected271 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00019 events18 affected201 at risk
EG0013 events2 affected31 at risk
EG00243 events37 affected271 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00013 events12 affected201 at risk
EG0013 events3 affected31 at risk
EG00239 events32 affected271 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00045 events43 affected201 at risk
EG0018 events8 affected31 at risk
EG00273 events62 affected271 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00029 events25 affected201 at risk
EG0019 events8 affected31 at risk
EG00261 events56 affected271 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00058 events49 affected201 at risk
EG00117 events11 affected31 at risk
EG002101 events75 affected271 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG00012 events12 affected201 at risk
EG0014 events4 affected31 at risk
EG00231 events30 affected271 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0009 events9 affected201 at risk
EG0011 events1 affected31 at risk
EG00216 events10 affected271 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected201 at risk
EG0011 events1 affected31 at risk
EG0028 events6 affected271 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected201 at risk
EG0018 events4 affected31 at risk
EG00212 events12 affected271 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG00010 events10 affected201 at risk
EG0012 events2 affected31 at risk
EG00225 events20 affected271 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00010 events10 affected201 at risk
EG0013 events3 affected31 at risk
EG00227 events25 affected271 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0008 events8 affected201 at risk
EG0014 events4 affected31 at risk
EG00218 events16 affected271 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected271 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected201 at risk
EG0010 events0 affected31 at risk
EG00211 events11 affected271 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected271 at risk
EG003
Influenza like illness
General disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0010 events0 affected31 at risk
EG00210 events8 affected271 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG00217 events16 affected271 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0006 events6 affected201 at risk
EG0011 events1 affected31 at risk
EG0026 events5 affected271 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0011 events1 affected31 at risk
EG00215 events14 affected271 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected271 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected201 at risk
EG0010 events0 affected31 at risk
EG0027 events7 affected271 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00010 events10 affected201 at risk
EG0011 events1 affected31 at risk
EG00226 events19 affected271 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 18.0
Systematic Assessment
EG0006 events6 affected201 at risk
EG0010 events0 affected31 at risk
EG00210 events9 affected271 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0028 events7 affected271 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG00010 events10 affected201 at risk
EG0016 events3 affected31 at risk
EG00238 events16 affected271 at risk
EG003
Weight decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0006 events6 affected201 at risk
EG0012 events2 affected31 at risk
EG00219 events19 affected271 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0011 events1 affected31 at risk
EG00210 events8 affected271 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected201 at risk
EG0010 events0 affected31 at risk
EG00220 events19 affected271 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0009 events9 affected201 at risk
EG0011 events1 affected31 at risk
EG00213 events13 affected271 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00010 events10 affected201 at risk
EG0010 events0 affected31 at risk
EG00222 events19 affected271 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0009 events9 affected201 at risk
EG0011 events1 affected31 at risk
EG00229 events25 affected271 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected201 at risk
EG0013 events3 affected31 at risk
EG00216 events15 affected271 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0006 events6 affected201 at risk
EG0011 events1 affected31 at risk
EG00214 events13 affected271 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0008 events8 affected201 at risk
EG0010 events0 affected31 at risk
EG0026 events6 affected271 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected201 at risk
EG0012 events2 affected31 at risk
EG00220 events20 affected271 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0010 events0 affected31 at risk
EG00212 events11 affected271 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected201 at risk
EG0010 events0 affected31 at risk
EG00211 events10 affected271 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0011 events1 affected31 at risk
EG0024 events4 affected271 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected201 at risk
EG0011 events1 affected31 at risk
EG0029 events9 affected271 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0009 events9 affected201 at risk
EG0014 events1 affected31 at risk
EG00215 events11 affected271 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0012 events2 affected31 at risk
EG00215 events14 affected271 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0011 events1 affected31 at risk
EG0028 events7 affected271 at risk
EG003
Blepharitis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0012 events2 affected31 at risk
EG0025 events5 affected271 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected271 at risk
EG003
Vision blurred
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected201 at risk
EG0013 events2 affected31 at risk
EG0023 events3 affected271 at risk
EG003
Face oedema
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected271 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected201 at risk
EG0012 events2 affected31 at risk
EG0026 events6 affected271 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected201 at risk
EG0014 events1 affected31 at risk
EG0024 events4 affected271 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG00213 events13 affected271 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected201 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected271 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0011 events1 affected31 at risk
EG0027 events7 affected271 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0012 events2 affected31 at risk
EG0025 events5 affected271 at risk
EG003
Renal function test abnormal
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected201 at risk
EG0012 events2 affected31 at risk
EG0027 events7 affected271 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0006 events6 affected201 at risk
EG0013 events3 affected31 at risk
EG0028 events8 affected271 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected201 at risk
EG0012 events2 affected31 at risk
EG0024 events4 affected271 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0013 events3 affected31 at risk
EG0027 events7 affected271 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected201 at risk
EG0012 events2 affected31 at risk
EG0027 events7 affected271 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected201 at risk
EG0010 events0 affected31 at risk
EG00211 events11 affected271 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected201 at risk
EG0010 events0 affected31 at risk
EG00213 events13 affected271 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected201 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected271 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected201 at risk
EG0014 events4 affected31 at risk
EG00211 events11 affected271 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected201 at risk
EG0014 events3 affected31 at risk
EG00217 events17 affected271 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected201 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected271 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected201 at risk
EG0013 events3 affected31 at risk
EG00210 events10 affected271 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected201 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected271 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected201 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected271 at risk
EG003
All 6 cohorts are still on-going. Data cut-off on 1st May 2015 was for primary analyses in main cohorts of dose escalation, dose expansion, extension. AEs presented for all cohorts.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review, should the submission for publication be delayed in order to file patent application. The sponsor cannot require changes to the communication and cannot extend the embargo.