A Study of ABT-414 in Participants With Newly Diagnosed G... | NCT02573324 | Trialant
NCT02573324
Sponsor
AbbVie
Status
Completed
Last Update Posted
May 11, 2023Actual
Enrollment
691Actual
Phase
Phase 3
Conditions
Glioblastoma
Gliosarcoma
Interventions
Temozolomide
Depatuxizumab mafodotin
Radiation
Placebo for ABT-414
Countries
United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Colombia
Czechia
France
Germany
Hong Kong
Ireland
Israel
Italy
Mexico
Netherlands
New Zealand
Portugal
Russia
Singapore
South Africa
South Korea
Spain
Switzerland
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02573324
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M13-813
Secondary IDs
ID
Type
Description
Link
2015-001166-26
EudraCT Number
Brief Title
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Official Title
A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
Acronym
Intellance1
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
May 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03123952No longer available
Start Date
Jan 4, 2015Actual
Primary Completion Date
Apr 4, 2022Actual
Completion Date
Apr 4, 2022Actual
First Submitted Date
Sep 28, 2015
First Submission Date that Met QC Criteria
Oct 8, 2015
First Posted Date
Oct 9, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 23, 2023
Results First Submitted that Met QC Criteria
May 8, 2023
Results First Posted Date
May 11, 2023Actual
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
May 8, 2023
Last Update Posted Date
May 11, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Name
Class
Radiation Therapy Oncology Group
NETWORK
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.
In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.
Detailed Description
Not provided
Conditions Module
Conditions
Glioblastoma
Gliosarcoma
Keywords
Newly Diagnosed Glioblastoma
Epithelial Growth Factor Receptor (EGFR)
Temozolomide
ABT-414
Radiology Therapy Oncology Group
Antibody Drug Conjugate
Brain Tumor
Brain Tumor Group
EGFRvIII
EGFR Amplified
First Line Therapy
Brain Cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
691Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ)
Experimental
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Drug: Temozolomide
Drug: Depatuxizumab mafodotin
Radiation: Radiation
Placebo, Radiation and TMZ
Placebo Comparator
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Drug: Temozolomide
Radiation: Radiation
Drug: Placebo for ABT-414
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ
Experimental
Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Drug: Temozolomide
Drug: Depatuxizumab mafodotin
Radiation: Radiation
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Temozolomide
Drug
Oral Capsule
Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ)
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Survival (OS)
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary Outcomes
Measure
Description
Time Frame
OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Unmethylated MGMT promoter is associated with a worse prognosis in GBM
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have a clinical diagnosis of glioblastoma (GBM).
Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.
Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).
Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).
Exclusion Criteria:
Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).
Prior chemo therapy or radiosensitizer for head and neck cancer.
Prior radiotherapy to the head or neck in overlap of radiation fields.
Prior therapy for glioblastoma or other invasive malignancy.
Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.
Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
An efficacy futility analysis, conducted in accordance with the SAP, generated a conclusive result of futility, meeting the main study's objective of determining whether the addition of Depatux-M to standard therapy improves overall survival. The study was modified at that point, remaining open until after all participants had discontinued study treatment. AbbVie therefore considered this study completed (according to the rules set out for the study) and not terminated.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo, Radiation and Temozolomide (TMZ)
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 26, 2019
Mar 23, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Japan
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Sub-study was open-label.
Who Masked
ParticipantCare ProviderInvestigator
Placebo, Radiation and TMZ
Depatuxizumab mafodotin
Drug
Intravenous (IV) Infusion
Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ)
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ
ABT-414
Radiation
Radiation
Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ)
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ
Placebo, Radiation and TMZ
Placebo for ABT-414
Drug
IV Infusion (IV)
Placebo, Radiation and TMZ
OS for the MGMT Methylated Group
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Progression-Free Survival (PFS)
PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
PFS for EGFRvIII-Mutated Tumor Subgroup
PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Deterioration Free Survival in MDASI-BT Symptom Interference Score
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score
The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Springdale
Arkansas
72762
United States
University of Southern California /ID# 147543
Los Angeles
California
90033
United States
University of California, Los Angeles /ID# 149239
Los Angeles
California
90095
United States
Sharp Memorial Hospital /ID# 148193
San Diego
California
92123
United States
Univ California, San Francisco /ID# 145889
San Francisco
California
94143-2204
United States
Duplicate_St. John's Health Center /ID# 148192
Santa Monica
California
90404
United States
Cedars-Sinai Medical Center-West Hollywood /ID# 148472
University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
Bloemfontein
Free State
9301
South Africa
Netcare Unitas Hospital /ID# 152936
Centurion
Gauteng
0140
South Africa
The Oncology Centre /ID# 143950
Durban
KwaZulu-Natal
4091
South Africa
Netcare Oncology Intervent Ctr /ID# 143951
Cape Town
Western Cape
7460
South Africa
Rondebosch Oncology Center /ID# 143949
Cape Town
Western Cape
7700
South Africa
Cape Town Oncology Trials /ID# 143948
Kraaifontein
Western Cape
7570
South Africa
National Cancer Center /ID# 141845
Goyang
Gyeonggido
10408
South Korea
Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846
Seoul
Seoul Teugbyeolsi
03722
South Korea
Seoul National University Hospital /ID# 143886
Seoul
03080
South Korea
Samsung Medical Center /ID# 143887
Seoul
06351
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844
Seoul
06591
South Korea
Hospital Regional de Malaga /ID# 143902
Málaga
Malaga
29010
Spain
Hospital Clinic de Barcelona /ID# 143906
Barcelona
08036
Spain
Hospital Santa Creu i Sant Pau /ID# 143900
Barcelona
08041
Spain
Hospital Clinico Universitario San Carlos /ID# 143901
Madrid
28040
Spain
Hospital Universitario 12 de Octubre /ID# 143930
Madrid
28041
Spain
Hospital Universitario HM Sanchinarro /ID# 143496
Madrid
28050
Spain
Hospital General Universitario de Valencia /ID# 143903
Valencia
46014
Spain
Kantonsspital Aarau AG /ID# 141885
Aarau
Canton of Aargau
5001
Switzerland
Universitatsspital Zurich /ID# 141887
Zurich
Canton of Zurich
8091
Switzerland
Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936
Bellinzona
6500
Switzerland
Inselspital, Universitätsspital Bern /ID# 141886
Bern
3010
Switzerland
National Taiwan University Hospital /ID# 143940
Taipei
100
Taiwan
Taipei Veterans General Hosp /ID# 143955
Taipei
11217
Taiwan
Linkou Chang Gung Memorial Hospital /ID# 143941
Taoyuan City
333
Taiwan
Guys and St Thomas NHS Foundation Trust /ID# 142652
London
London, City of
SE1 9RT
United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 154592
Birmingham
B15 2TH
United Kingdom
Velindre University NHS Trust /ID# 141996
Cardiff
CF15 7QZ
United Kingdom
Duplicate_NHS Tayside /ID# 141651
Dundee
DD2 1UB
United Kingdom
NHS Lothian /ID# 141802
Edinburgh
EH3 9HE
United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 141653
Leeds
LS9 7TF
United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 142658
London
NW1 2PG
United Kingdom
Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999
Newcastle upon Tyne
NE7 7DN
United Kingdom
Royal Marsden Hospital /ID# 142827
Sutton
SM2 5PT
United Kingdom
Derived
Gan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202.
Reardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
FG002
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
FG000341 subjects
FG001344 subjects
FG0026 subjects
Received Randomized Study Drug
FG000337 subjects
FG001344 subjects
FG0026 subjects
Entered Adjuvant Phase
FG000285 subjects
FG001273 subjects
FG0026 subjects
Entered Follow-Up Phase
FG000328 subjects
FG001326 subjects
FG0025 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG000341 subjects
FG001344 subjects
FG0026 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00026 subjects
FG00123 subjects
FG0023 subjects
Lost to Follow-up
FG0004 subjects
FG0015 subjects
FG0020 subjects
Study Terminated by Sponsor
FG000107 subjects
FG00189 subjects
FG0022 subjects
Death
FG000182 subjects
FG001200 subjects
FG0021 subjects
Other, Not Specified
FG00020 subjects
FG00127 subjects
FG0020 subjects
Unknown Reason
FG0002 subjects
FG0010 subjects
FG0020 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
BG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
BG002
Open-Label Substudy: Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000341
BG001344
BG0026
BG003691
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
BG00058.1± 10.42
BG00158.2± 10.14
BG00255.3± 10.58
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000137
BG001129
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0006
BG0017
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG00035
BG00135
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
Overall Survival (OS)
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study)
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
1.02
2-Sided
95
0.82
1.26
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.
Secondary
OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Unmethylated MGMT promoter is associated with a worse prognosis in GBM
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study) Participants with unmethylated MGMT promoter status.
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Secondary
OS for the MGMT Methylated Group
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study) Participants with methylated MGMT promoter status.
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Secondary
OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study) Participants with EGFR-VIII mutation status=mutated.
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Secondary
Progression-Free Survival (PFS)
PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur.
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study)
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Secondary
PFS for EGFRvIII-Mutated Tumor Subgroup
PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur.
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study) Participants with EGFR-VIII mutation status=mutated.
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Secondary
Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study)
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Secondary
Deterioration Free Survival in MDASI-BT Symptom Interference Score
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study)
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Secondary
Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score
The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death.
Full Analysis Set (FAS): all randomized participants (regardless of whether they received study treatment) satisfying the following criteria:
Enrollment date was on or prior to 31-Mar-2018
Enrolled in the main study (not in the open-label hepatic sub-study)
Posted
Median
95% Confidence Interval
months
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
ID
Title
Description
OG000
Placebo, Radiation and TMZ
Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Time Frame
All-Cause Mortality: From signing of informed consent through the end of follow-up (overall median of 17.9 months). Adverse Events: From the first dose of any study drug during each study phase and no later than 49 days after the last dose of depatuxizumab mafodotin or placebo during each study phase, or the start of a new phase. Overall, the median duration of study drug treatment was 6.0 and 7.9 months in the depatuxizumab mafodotin and placebo treatment arms, respectively.
Description
Safety Analysis Set: all randomized participants who received at least one dose of study treatment (either RT, TMZ, placebo or depatuxizumab mafodotin), classified according to treatment received. In the chemoradiation phase, 2 participants each did not have chemoradiation records in both the placebo and the depatuxizumab mafodotin arms; likewise for 2 participants in the placebo follow-up phase.
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
Placebo, Radiation and TMZ: Chemoradiation Phase
Placebo given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase.
4
335
56
335
290
335
EG001
Placebo, Radiation and TMZ: Adjuvant Phase
Placebo given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo given on Day 1 and 15 of each cycle, along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
13
285
85
285
255
285
EG002
Placebo, Radiation and TMZ: Follow Up Phase
Participants who complete placebo + TMZ adjuvant treatment or discontinue study drug prior to disease progression continue to undergo magnetic resonance imaging and assessment of neurocognitive functioning and patient reported outcomes approximately every 8 weeks up to and including at the time of disease progression, starting 8 weeks after the last scheduled assessments in the adjuvant phase. After disease progression, overall survival continues to be assessed quarterly.
180
326
0
326
1
326
EG003
Depatuxizumab Mafodotin, Radiation and TMZ: Chemoradiation Phase
Depatuxizumab mafodotin given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase.
4
342
68
342
337
342
EG004
Depatuxizumab Mafodotin, Radiation and TMZ: Adjuvant Phase
Depatuxizumab mafodotin given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin given on Day 1 and 15 of each cycle, along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
22
273
107
273
252
273
EG005
Depatuxizumab Mafodotin, Radiation and TMZ: Follow Up Phase
Participants who complete depatuxizumab mafodotin + TMZ adjuvant treatment or discontinue study drug prior to disease progression continue to undergo magnetic resonance imaging and assessment of neurocognitive functioning and patient reported outcomes approximately every 8 weeks up to and including at the time of disease progression, starting 8 weeks after the last scheduled assessments in the adjuvant phase. After disease progression, overall survival continues to be assessed quarterly.
188
326
2
326
2
326
EG006
Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Chemoradiation Phase
Open-label depatuxizumab mafodotin given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase.
0
6
1
6
6
6
EG007
Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Adjuvant Phase
Open-label depatuxizumab mafodotin given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin given on Day 1 and 15 of each cycle, along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
0
6
1
6
6
6
EG008
Open-Label Depatuxizumab Mafodotin, Radiation and TMZ: Follow Up Phase
Participants who complete open-label depatuxizumab mafodotin + TMZ adjuvant treatment or discontinue study drug prior to disease progression continue to undergo magnetic resonance imaging and assessment of neurocognitive functioning and patient reported outcomes approximately every 8 weeks up to and including at the time of disease progression, starting 8 weeks after the last scheduled assessments in the adjuvant phase. After disease progression, overall survival continues to be assessed quarterly.
1
5
0
5
0
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG0031 events1 affected342 at risk
EG0040 events0 affected273 at risk
EG0050 events0 affected326 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
APLASTIC ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BONE MARROW FAILURE
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DISSEMINATED INTRAVASCULAR COAGULATION
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
IMMUNE THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MYELOSUPPRESSION
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
THROMBOCYTOPENIC PURPURA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CARDIAC ARREST
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VENTRICULAR ARRHYTHMIA
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CORNEAL DYSTROPHY
Congenital, familial and genetic disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DIABETES INSIPIDUS
Endocrine disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CATARACT
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CATARACT NUCLEAR
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CORNEAL LESION
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EYELID FUNCTION DISORDER
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
KERATOPATHY
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
OPHTHALMOPLEGIA
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
OPTIC ISCHAEMIC NEUROPATHY
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
OPTIC NEUROPATHY
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RETINAL DETACHMENT
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ULCERATIVE KERATITIS
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ANAL INCONTINENCE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GASTRIC HAEMORRHAGE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0013 events3 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PANCREATITIS ACUTE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0013 events3 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ASTHENIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CHEST PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CONDITION AGGRAVATED
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FATIGUE
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPOTHERMIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
IMPAIRED HEALING
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MALAISE
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MULTIPLE ORGAN DYSFUNCTION SYNDROME
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PYREXIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0013 events3 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HEPATITIS
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
LIVER INJURY
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NODULAR REGENERATIVE HYPERPLASIA
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ANAPHYLACTIC REACTION
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ABDOMINAL SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ACUTE HEPATITIS B
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
APPENDICITIS PERFORATED
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BACTERIAL INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ENCEPHALITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ENCEPHALITIS VIRAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ESCHERICHIA BACTERAEMIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EXTRADURAL ABSCESS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EYE INFECTION STAPHYLOCOCCAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HERPES SIMPLEX
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HERPES SIMPLEX ENCEPHALITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HERPES SIMPLEX OESOPHAGITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected335 at risk
EG0014 events4 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PNEUMONIA ASPIRATION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PNEUMONIA STREPTOCOCCAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
POSTOPERATIVE WOUND INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PULMONARY SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SUBDURAL ABSCESS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BRAIN CONTUSION
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EPIDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EXPOSURE TO CONTAMINATED DEVICE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EXTRADURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HAND FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RADIATION NECROSIS
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0013 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SPINAL COMPRESSION FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SURGICAL PROCEDURE REPEATED
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
TRAUMATIC INTRACRANIAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FIBRIN D DIMER INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GLOMERULAR FILTRATION RATE DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0012 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPOPHAGIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HAEMARTHROSIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
LUMBAR SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BRAIN NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GLIOBLASTOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GLIOBLASTOMA MULTIFORME
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
LUNG NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG00110 events10 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NEOPLASM SWELLING
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PAPILLARY THYROID CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PLASMA CELL MYELOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PROSTATE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
APHASIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ATAXIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BRAIN OEDEMA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0007 events5 affected335 at risk
EG0015 events5 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CENTRAL NERVOUS SYSTEM LESION
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CENTRAL NERVOUS SYSTEM NECROSIS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CEREBRAL CYST
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CEREBRAL HAEMORRHAGE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CEREBRAL VENTRICLE DILATATION
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
COGNITIVE DISORDER
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CRANIAL NERVE DISORDER
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DEPRESSED LEVEL OF CONSCIOUSNESS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DYSKINESIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ENCEPHALOPATHY
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EPILEPSIA PARTIALIS CONTINUA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EPILEPSY
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FACIAL PARALYSIS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0012 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FACIAL PARESIS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FOCAL DYSCOGNITIVE SEIZURES
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GENERALISED TONIC-CLONIC SEIZURE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HAEMORRHAGE INTRACRANIAL
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0014 events4 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HEMIPARESIS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0013 events3 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYDROCEPHALUS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
INTRACRANIAL PRESSURE INCREASED
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected335 at risk
EG0013 events3 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ISCHAEMIC STROKE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
LOSS OF CONSCIOUSNESS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MOTOR DYSFUNCTION
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NERVOUS SYSTEM DISORDER
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NEUROLOGICAL DECOMPENSATION
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PARTIAL SEIZURES
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PERIPHERAL MOTOR NEUROPATHY
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00013 events12 affected335 at risk
EG00122 events19 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
STATUS EPILEPTICUS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0012 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VASOGENIC CEREBRAL OEDEMA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
AGGRESSION
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DELIRIUM
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MENTAL STATUS CHANGES
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ORGANIC BRAIN SYNDROME
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RENAL COLIC
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
UTERINE HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ATELECTASIS
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ANGIOEDEMA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EUTHANASIA
Surgical and medical procedures
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
AORTIC STENOSIS
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SUPERFICIAL VEIN THROMBOSIS
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
THROMBOSIS
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00029 events21 affected335 at risk
EG00121 events14 affected285 at risk
EG0020 events0 affected326 at risk
EG00323 events15 affected342 at risk
EG00427 events14 affected273 at risk
EG0050 events0 affected326 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00037 events21 affected335 at risk
EG00186 events26 affected285 at risk
EG0020 events0 affected326 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00095 events50 affected335 at risk
EG001162 events38 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00046 events27 affected335 at risk
EG00149 events25 affected285 at risk
EG0020 events0 affected326 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG00080 events47 affected335 at risk
EG001193 events75 affected285 at risk
EG0020 events0 affected326 at risk
EG003
TINNITUS
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected335 at risk
EG0016 events6 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CATARACT
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0004 events3 affected335 at risk
EG00111 events10 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CORNEAL EPITHELIAL MICROCYSTS
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DRY EYE
Eye disorders
MedDRA 24.1
Systematic Assessment
EG00020 events20 affected335 at risk
EG00112 events12 affected285 at risk
EG0020 events0 affected326 at risk
EG003
EYE PAIN
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0009 events8 affected335 at risk
EG0019 events8 affected285 at risk
EG0020 events0 affected326 at risk
EG003
KERATITIS
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0014 events3 affected285 at risk
EG0020 events0 affected326 at risk
EG003
KERATOPATHY
Eye disorders
MedDRA 24.1
Systematic Assessment
EG00016 events16 affected335 at risk
EG00117 events12 affected285 at risk
EG0020 events0 affected326 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0008 events8 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
OCULAR HYPERAEMIA
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PHOTOPHOBIA
Eye disorders
MedDRA 24.1
Systematic Assessment
EG00016 events16 affected335 at risk
EG00113 events12 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PUNCTATE KERATITIS
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected335 at risk
EG0018 events7 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 24.1
Systematic Assessment
EG00022 events21 affected335 at risk
EG00117 events15 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VISUAL FIELD DEFECT
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0006 events6 affected335 at risk
EG00121 events20 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00089 events79 affected335 at risk
EG00163 events51 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00019 events16 affected335 at risk
EG00129 events24 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0005 events3 affected335 at risk
EG0018 events5 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0006 events5 affected335 at risk
EG0017 events6 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GINGIVAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HAEMORRHOIDAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPERAESTHESIA TEETH
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00087 events79 affected335 at risk
EG001133 events87 affected285 at risk
EG0020 events0 affected326 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00024 events23 affected335 at risk
EG00163 events50 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ASTHENIA
General disorders
MedDRA 24.1
Systematic Assessment
EG00022 events17 affected335 at risk
EG00121 events17 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CHILLS
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FATIGUE
General disorders
MedDRA 24.1
Systematic Assessment
EG000130 events110 affected335 at risk
EG001140 events77 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MALAISE
General disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected335 at risk
EG0013 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
OEDEMA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0012 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PYREXIA
General disorders
MedDRA 24.1
Systematic Assessment
EG00012 events12 affected335 at risk
EG00114 events12 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SWELLING
General disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BACTERIAL INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0009 events9 affected335 at risk
EG00120 events17 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected335 at risk
EG0015 events4 affected285 at risk
EG0020 events0 affected326 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0009 events7 affected335 at risk
EG00130 events21 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RADIATION SKIN INJURY
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG00022 events21 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00030 events26 affected335 at risk
EG00116 events13 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00026 events23 affected335 at risk
EG0017 events7 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0009 events7 affected335 at risk
EG00111 events7 affected285 at risk
EG0020 events0 affected326 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00022 events15 affected335 at risk
EG00123 events16 affected285 at risk
EG0021 events1 affected326 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00010 events8 affected335 at risk
EG00117 events10 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00012 events10 affected335 at risk
EG00122 events14 affected285 at risk
EG0020 events0 affected326 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected335 at risk
EG00131 events30 affected285 at risk
EG0020 events0 affected326 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected335 at risk
EG00111 events8 affected285 at risk
EG0020 events0 affected326 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG00020 events10 affected335 at risk
EG00145 events17 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00036 events36 affected335 at risk
EG00156 events44 affected285 at risk
EG0020 events0 affected326 at risk
EG003
GOUT
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0012 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG00015 events12 affected335 at risk
EG00114 events11 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0006 events6 affected335 at risk
EG0014 events4 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0006 events6 affected335 at risk
EG00132 events25 affected285 at risk
EG0020 events0 affected326 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected335 at risk
EG00118 events18 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0007 events6 affected335 at risk
EG00110 events9 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0009 events8 affected335 at risk
EG00119 events12 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected335 at risk
EG00112 events11 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected335 at risk
EG00125 events18 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0013 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
APHASIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00010 events10 affected335 at risk
EG00120 events15 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00019 events19 affected335 at risk
EG00138 events31 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00020 events18 affected335 at risk
EG0015 events5 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00073 events64 affected335 at risk
EG00180 events52 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HEMIPARESIS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00013 events11 affected335 at risk
EG00128 events21 affected285 at risk
EG0020 events0 affected326 at risk
EG003
MEMORY IMPAIRMENT
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected335 at risk
EG00122 events21 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0007 events6 affected335 at risk
EG00119 events17 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PAROSMIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected335 at risk
EG0017 events5 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG00016 events15 affected335 at risk
EG00131 events19 affected285 at risk
EG0020 events0 affected326 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected335 at risk
EG00112 events10 affected285 at risk
EG0020 events0 affected326 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected335 at risk
EG00111 events9 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG00012 events11 affected335 at risk
EG00111 events11 affected285 at risk
EG0020 events0 affected326 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG00020 events18 affected335 at risk
EG00125 events22 affected285 at risk
EG0020 events0 affected326 at risk
EG003
NOCTURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0011 events1 affected285 at risk
EG0020 events0 affected326 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG00020 events19 affected335 at risk
EG00126 events25 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0012 events2 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
STRIDOR
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG000103 events97 affected335 at risk
EG00110 events10 affected285 at risk
EG0020 events0 affected326 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG00018 events17 affected335 at risk
EG0019 events9 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PHOTOSENSITIVITY REACTION
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG00016 events14 affected335 at risk
EG00123 events18 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0009 events9 affected335 at risk
EG00120 events14 affected285 at risk
EG0020 events0 affected326 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0018 events5 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPERAEMIA
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected335 at risk
EG0010 events0 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG00010 events8 affected335 at risk
EG00123 events15 affected285 at risk
EG0020 events0 affected326 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0009 events9 affected335 at risk
EG0015 events4 affected285 at risk
EG0020 events0 affected326 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Superiority
Units
Counts
Participants
OG000199
OG001205
Title
Denominators
Categories
Title
Measurements
OG00016.2(14.7 to 17.7)
OG00116.1(14.6 to 18.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.504
Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
0.97
2-Sided
95
0.76
1.24
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.
Superiority
OG000
OG001
Log Rank
0.599
Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Superiority
Units
Counts
Participants
OG000117
OG001118
Title
Denominators
Categories
Title
Measurements
OG000NA(21.2 to NA)Median and upper limit of confidence interval not estimable due to the small number of events.
OG00125.4(21.6 to 27.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.773
Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
1.17
2-Sided
95
0.76
1.80
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.
Superiority
OG000
OG001
Log Rank
0.740
Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Superiority
Units
Counts
Participants
OG000168
OG001164
Title
Denominators
Categories
Title
Measurements
OG00018.2(15.7 to 19.5)
OG00119.8(17.8 to 23.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.381
Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
0.95
2-Sided
95
0.71
1.27
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.
Superiority
OG000
OG001
Log Rank
0.409
Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Superiority
Units
Counts
Participants
OG000316
OG001323
Title
Denominators
Categories
Title
Measurements
OG0006.3(5.9 to 7.9)
OG0018.0(6.2 to 9.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.029
Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
0.84
2-Sided
95
0.70
1.01
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.
Superiority
Units
Counts
Participants
OG000168
OG001164
Title
Denominators
Categories
Title
Measurements
OG0005.9(4.8 to 7.7)
OG0018.3(6.1 to 10.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.002
Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
0.72
2-Sided
95
0.56
0.93
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.
Superiority
OG001
Depatuxizumab Mafodotin, Radiation and TMZ
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Units
Counts
Participants
OG000316
OG001323
Title
Denominators
Categories
Title
Measurements
OG00011.0(8.05 to 12.71)
OG0016.1(4.57 to 8.02)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.994
Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
1.329
2-Sided
95
1.087
1.626
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.
Superiority
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Units
Counts
Participants
OG000316
OG001323
Title
Denominators
Categories
Title
Measurements
OG0009.7(7.79 to 12.19)
OG0016.1(4.57 to 8.84)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.938
Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
1.185
2-Sided
95
0.972
1.446
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.
Superiority
Units
Counts
Participants
OG000316
OG001323
Title
Denominators
Categories
Title
Measurements
OG00013.2(11.53 to 14.59)
OG00110.7(8.18 to 13.14)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.814
Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.
Cox Proportional Hazard
1.136
2-Sided
95
0.921
1.402
Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.