Study of AMG 596 in Patients With EGFRvIII Positive Gliob... | NCT03296696 | Trialant
NCT03296696
Sponsor
Amgen
Status
Terminated
Last Update Posted
Oct 29, 2024Actual
Enrollment
30Actual
Phase
Phase 1
Conditions
Glioblastoma or Malignant Glioma
Interventions
AMG 596
AMG 404
Countries
United States
Australia
France
Germany
Netherlands
Spain
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03296696
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20160132
Secondary IDs
ID
Type
Description
Link
2017-001658-32
EudraCT Number
Brief Title
Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma
Official Title
Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 as Monotherapy and in Combination With AMG 404 in Subjects With Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Amgen business decision
Expanded Access Info
No
Start Date
Apr 18, 2018Actual
Primary Completion Date
Jul 1, 2021Actual
Completion Date
Aug 28, 2021Actual
First Submitted Date
Sep 18, 2017
First Submission Date that Met QC Criteria
Sep 27, 2017
First Posted Date
Sep 28, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jun 26, 2024
Results First Submitted that Met QC Criteria
Oct 28, 2024
Results First Posted Date
Oct 29, 2024Actual
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
Oct 28, 2024
Last Update Posted Date
Oct 29, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII).
This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma or malignant glioma. This study will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment after SoC in newly diagnosed disease (Group 2).
Detailed Description
Not provided
Conditions Module
Conditions
Glioblastoma or Malignant Glioma
Keywords
Phase 1/1b
EGFRvIII-positive glioblastoma or malignant glioma
safety and tolerability
AMG 596
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
30Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose exploration
Experimental
Dose exploration of the intervention, AMG 596 alone or in combination with AMG 404
Drug: AMG 596
Drug: AMG 404
Dose expansion
Experimental
Dose expansion of the intervention, AMG 596 alone or in combination with AMG 404
Drug: AMG 596
Drug: AMG 404
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AMG 596
Drug
Drug
Dose expansion
Dose exploration
AMG 404
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was any of the following occurring and regarded by the investigator as related to AMG 596. Hematological DLTs: absolute neutrophil count (ANC) <0.5×10^9/L for ≥7 days, febrile neutropenia with ANC<0.5×10^9/L and fever ≥38.5°C, platelets<50×10^9/L>7 days or clinically significant bleeding. Non-hematological DLTs: any grade 4 non-hematological toxicity, any grade ≥3 non-hematological toxicity if nausea and vomiting, grade 3 non-hematologic toxicity lasting >3 days despite treatment, grade 3 fatigue wasn't classified as DLT, grade 3 acute kidney injury, grade 3 seizure, ataxia, encephalopathy, other grade 3 neurologic-related adverse events lasting >3 days despite treatment, neurologic-related adverse event leading to treatment interruption needing>1 week to resolve to grade≤1, any grade 3 endocrinopathy that can't be controlled by hormonal replacement. Toxicity grading was graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Up to 28 days
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was any AE that begun or worsened after the initial dose of investigational product. Any clinically significant changes in vital signs, physical examinations, and clinical laboratory tests that begun or worsened after the initial dose of investigational product were recorded as TEAEs.
First dose of study drug until 37 days after last dose or end of study, whichever is earlier. Duration with median (min, max) in months: 3.32 (1.28, 29.31)
Number of Participants With Treatment-Related Adverse Events (AEs)
A treatment-related AE was defined as any untoward medical occurrence in a clinical trial participant that was considered related to the investigational product. Any clinically significant changes in vital signs, physical examinations, and clinical laboratory tests that were considered related to the investigational product were recorded as treatment-related AEs.
First dose of study drug until 37 days after last dose or end of study, whichever is earlier. Duration with median (min, max) in months: 3.32 (1.28, 29.31)
Secondary Outcomes
Measure
Description
Time Frame
Average Steady-state Concentration (Css) of Serum AMG 596
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
Area Under the Concentration-time Curve (AUC) for Serum AMG 596
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Eastern Cooperative Oncology Group (ECOG, Appendix G) Performance Status of less than or equal to 1
Life expectancy of at least 3 months, in the opinion of the investigator.
Must have pathologically documented, and definitively diagnosed World Health Organization (WHO) grade 4, glioblastoma or lower grade malignant gliomas with epidermal growth factor receptor variant III (EGFRvIII) positive tumor
Must have recurrent disease confirmed by magnetic resonance imaging (MRI) (Group 1) or completed standard of care (SoC) therapy such as surgery with adjuvant radiochemotherapy with or without maintenance temozolomide according to local standards for newly diagnosed disease (Group 2)
Platelet count greater than 100,000 mm3 (100 × 10 9/L)
White blood cell (WBC) count greater than 3 × 10 9/L
Hemoglobin greater than 9.0 g/dL
Renal function as follows: serum creatinine less than 2.0 mg/dL and estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73 m2 by Modification of Diet in Renal Disease (MDRD) and urine protein quantitative value of less than 30 mg/dL in urinalysis or less than or equal to 1+ on dipstick
Hepatic function as follows:
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) less than or equal to 3.0 x upper limit of normal (ULN)
Bilirubin less than or equal to 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis)
Exclusion Criteria
History or evidence of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) not associated with any antitumor surgery within 6 months before enrolment
Evidence of acute intracranial / intratumoral hemorrhage, except for subjects with stable grade 1 hemorrhage or fresh biopsy
Known hypersensitivity to immunoglobulins or to any other component of the investigational product (IP) formulation
Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening
Active infection requiring intravenous antibiotics that was completed less than 1 week of study enrolment (day 1) with the exemption of prophylactic antibiotics for long line insertion or biopsy
Known positive test for human immunodeficiency virus (HIV)
Active hepatitis B and C based on the following results:
Positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
Negative HepBsAg and positive for hepatitis B core antibody: hepatitis B virus deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B
Positive hepatitis C virus antibody (HepCAb): hepatitis C virus ribonucleic acid (RNA) by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C Common terminology criteria for adverse events
Unresolved toxicities from prior antitumor therapy, defined as not having resolved to common terminology criteria for adverse events (CTCAE), version 4.0 grade 1 (with the exception of myelosuppression, eg, neutropenia, anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible (defined as having been present and stable for greater than 2 months) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor
Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, or investigational agent) within 14 days (Group 2 subjects) or 5 half-lives (whichever is longer: for Group 1 subjects) of day 1. Avastin, Pembrolizumab must be stopped 14 days prior to day 1
Treatment with non-topical systemic corticosteroids within 14 days before enrollment (day 1) (exemption: prophylactic treatment with dexamethasone as defined in section 6.5, and systemic corticosteroid doses of ≤ 2 mg of dexamethasone (or equivalent) per day after consultation with Sponsor,)
Prior participation in an investigational study (drug, procedure or device) within 21 days of study day 1
Major surgery within 7 days of study day 1 with the exception of biopsy and long line insertion
History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Male and female of reproductive potential who are unwilling to practice highly effective method(s) of birth control while on study and through 30 days after receiving the last dose of AMG 596 and through 4 months (120 days) after receiving the last dose of AMG 404.
Criteria for women of non-reproductive potential is as follows:
Postmenopausal as defined as:
Age of 55 years with cessation of menses for 12 months or more, OR
Age < 55 years and no spontaneous menses for at least 2 years, OR
Age < 55 years and spontaneous menses within the past year, but currently amenorrheic (eg, spontaneous or secondary to chemotherapy) AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone level > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) according to the definition of "postmenopausal range" for the laboratory involved; OR
History of hysterectomy; OR
History of bilateral oophorectomy
Highly effective methods of birth control include sexual abstinence (male, female); vasectomy; bilateral tubal ligation/occlusion; hormonal birth control or intrauterine device (IUD) (female).
Female who is lactating/breastfeeding or who plans to breastfeed while on study through 30 days after receiving the last dose of AMG 596 and through 4 months (120 days) after receiving the last dose of AMG 404.
Female with a positive pregnancy test.
Female planning to become pregnant while on study through 30 days after receiving the last dose of AMG 596 and through 4 months (120 days) after receiving the last dose of AMG 404 infusion.
Male who is unwilling to abstain from sperm donation while on study through 30 days after receiving the last dose of AMG 596 and through 4 months (120 days) after receiving the last dose of AMG 404.
Subjects likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
History of solid organ transplantation. Prior treatment with anti-PD-1, anti-PD-L1, CTLA-4 or other checkpoint inhibitor drugs
Prior treatment with AMG 596 monotherapy arm is not eligible to enroll in the combination therapy arm.
Live vaccine therapies within 4 weeks prior to study drug administration
Evidence of interstitial lung disease or active, non-infectious pneumonitis
History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis.
Active or history of any autoimmune disease or immunodeficiencies. Subjects with Type I diabetes, vitiligo, psoriasis, hypo-or hyper-thyroid disease not requiring immune-suppressive treatment are permitted.
Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication.
Sternjak A, Lee F, Thomas O, Balazs M, Wahl J, Lorenczewski G, Ullrich I, Muenz M, Rattel B, Bailis JM, Friedrich M. Preclinical Assessment of AMG 596, a Bispecific T-cell Engager (BiTE) Immunotherapy Targeting the Tumor-specific Antigen EGFRvIII. Mol Cancer Ther. 2021 May;20(5):925-933. doi: 10.1158/1535-7163.MCT-20-0508. Epub 2021 Feb 25.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Of the planned 200 participants, 30 were enrolled. Of the 30 participants enrolled, 29 received investigational product. Due to early termination, participants were only enrolled into dose escalation AMG 596 monotherapy arms.
Recruitment Details
Participants were enrolled from April 18, 2018 and last participant visit was August 28, 2021. Participants enrolled at 9 centers in United States, Australia, France, Germany, Netherlands, and Spain.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
FG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
FG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
FG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
FG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
FG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
FG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
FG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
FG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
FG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
FG0064 subjects
FG0075 subjects
FG0081 subjects
FG0091 subjects
Received Investigational Product
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Started Other Antitumor Therapy
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Baseline data were collected for all enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
BG001
AMG 596 Monotherapy 15 mcg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
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
Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was any of the following occurring and regarded by the investigator as related to AMG 596. Hematological DLTs: absolute neutrophil count (ANC) <0.5×10^9/L for ≥7 days, febrile neutropenia with ANC<0.5×10^9/L and fever ≥38.5°C, platelets<50×10^9/L>7 days or clinically significant bleeding. Non-hematological DLTs: any grade 4 non-hematological toxicity, any grade ≥3 non-hematological toxicity if nausea and vomiting, grade 3 non-hematologic toxicity lasting >3 days despite treatment, grade 3 fatigue wasn't classified as DLT, grade 3 acute kidney injury, grade 3 seizure, ataxia, encephalopathy, other grade 3 neurologic-related adverse events lasting >3 days despite treatment, neurologic-related adverse event leading to treatment interruption needing>1 week to resolve to grade≤1, any grade 3 endocrinopathy that can't be controlled by hormonal replacement. Toxicity grading was graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
The DLT Evaluable Analysis Set included all participants in the 7-day on/7-day off dosing groups who completed 100% of planned doses and all participants in the 28-day on/14-day off dosing groups who completed 90% of planned doses.
Posted
Count of Participants
Participants
Up to 28 days
Adverse Events Module
Frequency Threshold
5
Time Frame
Mortality duration with median (min, max) in months: 4.27 (0.20, 35.48). Adverse Event duration with median (min, max) in months: 3.32 (1.28, 29.31).
Description
Serious and Other Adverse Events were collected for all participants who received at least one dose of study drug. All Cause Mortality was collected for all enrolled participants.
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
AMG596 4.5 mcg
AMG596 4.5 mcg/day 7 Day cIV
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
More Info Module
Limitations and Caveats
The study was terminated early. Therefore, a smaller number of participants than planned were enrolled and analysed.
There were insufficient evaluable samples collected for the determination of AUC.
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
Clearance for Serum AMG 596
Clearance (CL) is calculated based on dose and AUC.
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
Apparent Volume of Distribution at Steady-State for Serum AMG 596
The formula for volume of distribution is dose/concentration. For this study, the dose is measured in mcg/day and concentration is measure as ng/mL resulting in units of mcg/day/(ng/mL) for volume of distribution.
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
Terminal Half-life (t1/2) Associated With Lambda z (λz) for Serum AMG 596
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
Number of Participants With an Objective Response (OR) Per Modified Response Assessment in Neuro-Oncology Criteria (RANO) Criteria With AMG 596 Monotherapy
Objective response was defined as the number of participants with complete response (CR) or partial response (PR) per modified RANO criteria. CR per modified RANO: disappearance of all enhancing disease, no new lesions, stable or improved T2-weighted fluid-attenuated inversion recovery (T2/FLAIR), no more than physiological steroids, clinically stable or improved, disappearance confirmed with follow-up scans after ≥4 weeks. PR per modified RANO: ≥50% decrease in the sum of perpendicular diameters of enhancing disease from baseline, stable or improved T2/FLAIR, stable or decreased steroid dose, clinically stable or improved, decrease confirmed with follow up scan after ≥ 4 weeks.
Baseline up to 12 Months
Time to Response With AMG 596 Monotherapy
Time to response was calculated as the number of months from the date of first administration of AMG 596 to the date of confirmation of first objective response per magnetic resonance imaging (MRI) scan. If a participant did not respond, time to response was censored at the date of the last evaluable response assessment.
Up to 12 months
Response Duration With AMG 596 Monotherapy
Response duration was analysed as the number of months between the first tumor response assessment of an OR (PR or CR) which is subsequently confirmed to the time of the first tumor response assessment of progressive disease or death if due to disease progression.
Up to 30 months
Time to Progression (TTP) With AMG 596 Monotherapy
The TTP was calculated as the time from the date of first dose of AMG 596 until the date of diagnosis of progression of tumor. Participants who did not have progression were censored at the last radiological non-missing evaluable tumor assessment date.
Up to 12 Months
Progression-free Survival (PFS) With AMG 596 Monotherapy
The PFS was calculated as the time from the date of first dose of AMG 596 until the date of diagnosis of progression of tumor, or date of death, whichever was earlier.
Up to 12 months
New York
New York
10065
United States
Royal North SHore Hospital
St Leonards
New South Wales
2065
Australia
Peter MacCallum Cancer Centre
Melbourne
Victoria
3000
Australia
Gustave Roussy
Villejuif
94800
France
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Dresden
01307
Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg
20246
Germany
Universitaetsklinikum Wuerzburg
Würzburg
97080
Germany
Vrije Universiteit Medisch Centrum
Amsterdam
1081 HV
Netherlands
Hospital Universitari Germans Trias i Pujol
Badalona
Cataluña
08916
Spain
3 subjects
FG0054 subjects
FG0064 subjects
FG0075 subjects
FG0081 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
4 subjects
FG0054 subjects
FG0063 subjects
FG0075 subjects
FG0081 subjects
FG0091 subjects
2 subjects
FG0041 subjects
FG0051 subjects
FG0062 subjects
FG0073 subjects
FG0081 subjects
FG0090 subjects
Death
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0042 subjects
FG0053 subjects
FG0061 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
BG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
BG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
BG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
BG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
BG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
BG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
BG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
BG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
BG010
Total
Total of all reporting groups
1
BG0013
BG0023
BG0034
BG0044
BG0054
BG0064
BG0075
BG0081
BG0091
BG01030
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Between 18 and 65 years
BG0001
BG0013
BG0023
BG0033
BG004
>=65 years
BG0000
BG0010
BG0020
BG0031
BG004
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00062.0± NAStandard deviation cannot be calculated for a single participant.
BG00151.0± 6.1
BG00256.7± 8.7
BG00358.0± 7.5
BG00451.5± 13.6
BG00555.0± 4.9
BG00651.5± 12.4
BG00753.0± 5.5
BG00844.0± NAStandard deviation cannot be calculated for a single participant.
BG00949.0± NAStandard deviation cannot be calculated for a single participant.
BG01054.1± 7.7
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG0020
BG0032
BG0041
BG0051
BG0061
BG0070
BG0081
BG0091
BG01010
Male
BG0000
BG0011
BG0023
BG0032
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Not Hispanic or Latino
BG0001
BG0013
BG0023
BG0034
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Asian
BG0000
BG0011
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0001
BG0012
BG0023
BG0034
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG0034
OG0043
OG0054
OG0064
OG0075
OG0081
OG0091
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was any AE that begun or worsened after the initial dose of investigational product. Any clinically significant changes in vital signs, physical examinations, and clinical laboratory tests that begun or worsened after the initial dose of investigational product were recorded as TEAEs.
The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596.
Posted
Count of Participants
Participants
First dose of study drug until 37 days after last dose or end of study, whichever is earlier. Duration with median (min, max) in months: 3.32 (1.28, 29.31)
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0023
OG003
Primary
Number of Participants With Treatment-Related Adverse Events (AEs)
A treatment-related AE was defined as any untoward medical occurrence in a clinical trial participant that was considered related to the investigational product. Any clinically significant changes in vital signs, physical examinations, and clinical laboratory tests that were considered related to the investigational product were recorded as treatment-related AEs.
The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596.
Posted
Count of Participants
Participants
First dose of study drug until 37 days after last dose or end of study, whichever is earlier. Duration with median (min, max) in months: 3.32 (1.28, 29.31)
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0023
OG003
Secondary
Average Steady-state Concentration (Css) of Serum AMG 596
The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint.
Posted
Mean
Full Range
ng/mL
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
Secondary
Area Under the Concentration-time Curve (AUC) for Serum AMG 596
There were insufficient evaluable samples collected for the determination of AUC.
The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint. 0 participants had evaluable data for the determination of AUC, therefore 0 participants were analyzed for this endpoint.
Posted
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Clearance for Serum AMG 596
Clearance (CL) is calculated based on dose and AUC.
The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint.
Posted
Mean
Full Range
mcg/day/(hr*ng/mL)
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
Secondary
Apparent Volume of Distribution at Steady-State for Serum AMG 596
The formula for volume of distribution is dose/concentration. For this study, the dose is measured in mcg/day and concentration is measure as ng/mL resulting in units of mcg/day/(ng/mL) for volume of distribution.
The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint.
Posted
Mean
Full Range
mcg/day/(ng/mL)
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
Secondary
Terminal Half-life (t1/2) Associated With Lambda z (λz) for Serum AMG 596
The pharmacokinetic (PK) analysis set contained all participants who received the investigational product and had available PK data for each timepoint.
Posted
Mean
Full Range
Hours
Cycle1 to Cycle2 (cycle=14 days in single participant cohorts,42 days in multiple participant cohorts):7-days on/7-days off dosing and 28-days on/14-days off dosing:pre-infusion,2,6,8,24,48hrs post-infusion start,0.5,2,4,8,24hrs post infusion end
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG003
Secondary
Number of Participants With an Objective Response (OR) Per Modified Response Assessment in Neuro-Oncology Criteria (RANO) Criteria With AMG 596 Monotherapy
Objective response was defined as the number of participants with complete response (CR) or partial response (PR) per modified RANO criteria. CR per modified RANO: disappearance of all enhancing disease, no new lesions, stable or improved T2-weighted fluid-attenuated inversion recovery (T2/FLAIR), no more than physiological steroids, clinically stable or improved, disappearance confirmed with follow-up scans after ≥4 weeks. PR per modified RANO: ≥50% decrease in the sum of perpendicular diameters of enhancing disease from baseline, stable or improved T2/FLAIR, stable or decreased steroid dose, clinically stable or improved, decrease confirmed with follow up scan after ≥ 4 weeks.
The RANO Evaluable Analysis set included all participants that were enrolled and received at least one administration of AMG 596 and who had at least one measurable lesion identified by the Principal Investigator at baseline.
Posted
Count of Participants
Participants
Baseline up to 12 Months
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Secondary
Time to Response With AMG 596 Monotherapy
Time to response was calculated as the number of months from the date of first administration of AMG 596 to the date of confirmation of first objective response per magnetic resonance imaging (MRI) scan. If a participant did not respond, time to response was censored at the date of the last evaluable response assessment.
The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596. Only participants with OR were used for this analysis.
Posted
Median
80% Confidence Interval
Months
Up to 12 months
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG0017.0(NA to NA)Only 1 participant with evaluable data, therefore lower and upper confidence intervals could not be calculated.
Secondary
Response Duration With AMG 596 Monotherapy
Response duration was analysed as the number of months between the first tumor response assessment of an OR (PR or CR) which is subsequently confirmed to the time of the first tumor response assessment of progressive disease or death if due to disease progression.
The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596. Only participants with OR were used for this analysis.
Posted
Median
80% Confidence Interval
Months
Up to 30 months
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG00127.9(NA to NA)Only 1 participant with evaluable data, therefore lower and upper confidence intervals could not be calculated.
Secondary
Time to Progression (TTP) With AMG 596 Monotherapy
The TTP was calculated as the time from the date of first dose of AMG 596 until the date of diagnosis of progression of tumor. Participants who did not have progression were censored at the last radiological non-missing evaluable tumor assessment date.
The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596
Posted
Median
80% Confidence Interval
Months
Up to 12 Months
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.1(NA to NA)Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
OG0011.9(0.7 to NA)Values are not evaluable as the upper limit was not reached.
OG002
Secondary
Progression-free Survival (PFS) With AMG 596 Monotherapy
The PFS was calculated as the time from the date of first dose of AMG 596 until the date of diagnosis of progression of tumor, or date of death, whichever was earlier.
The safety analysis set included all participants who were enrolled and received at least 1 dose of AMG 596.
Posted
Median
80% Confidence Interval
Months
Up to 12 months
ID
Title
Description
OG000
AMG 596 Monotherapy 4.5 mcg
Participants received 4.5 mcg of AMG 596 by continuous intravenous (cIV) infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG001
AMG 596 Monotherapy 15 mcg
The first participant received 15 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied. The remaining 2 participants received 15 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG002
AMG 596 Monotherapy 45 mcg
Participants received 45 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG003
AMG 596 Monotherapy 150 mcg
Participants received 150 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG004
AMG596 Monotherapy 500 mcg
Participants received 500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG005
AMG596 Monotherapy 1000 mcg
Participants received 1000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG006
AMG596 Monotherapy 1500 mcg
Participants received 1500 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG007
AMG596 Monotherapy 3000 mcg
Participants received 3000 mcg of AMG 596 by cIV infusion on a 28-days on/14-days off dosing schedule until treatment discontinuation criteria were applied.
OG008
AMG596 Monotherapy 6000 mcg
Participants received 6000 mcg of AMG 596 by cIV infusion on a 7-days on/7-days off dosing schedule until treatment discontinuation criteria were applied.
OG009
AMG596 Monotherapy 1500/15 mcg
The participant was enrolled into AMG 596 Monotherapy 15 mcg cIV infusion arm but received an overdose (1500 mcg). Based on Food and Drug Administration recommendation, the participant received 1500 mcg/day during Week 1, followed by 15 mcg/day during Weeks 2 to 4, followed by a 2-week break.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.1(NA to NA)Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
OG0011.9(0.7 to NA)Upper confidence limit could not be calculated due to the low number of events reported.
OG002
1
0
1
1
1
EG001
AMG596 15 mcg
AMG596 15 mcg/day 7/28 Day cIV
1
3
3
3
3
3
EG002
AMG596 45 mcg
AMG596 45 mcg/day 28 Day cIV
1
3
1
3
3
3
EG003
AMG596 150 mcg
AMG596 150 mcg/day 28 Day cIV
2
4
3
4
4
4
EG004
AMG596 500 mcg
AMG596 500 mcg/day 28 Day cIV
2
4
2
3
3
3
EG005
AMG596 1000 mcg
AMG596 1000 mcg/day 28 Day cIV
3
4
2
4
3
4
EG006
AMG596 1500 mcg
AMG596 1500 mcg/day 28 Day cIV
1
4
3
4
4
4
EG007
AMG596 3000 mcg
AMG596 3000 mcg/day 28 Day cIV
2
5
3
5
5
5
EG008
AMG596 6000 mcg
AMG596 6000 mcg/day 28 Day cIV
0
1
1
1
1
1
EG009
AMG596 1500/15 mcg
AMG596 1500/15 mcg/day 28 Day cIV
0
1
1
1
1
1
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
General physical health deterioration
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hyperthermia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Catheter site infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Device related infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Vascular access site infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Vascular device infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Wound infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Shunt malfunction
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Glioblastoma multiforme
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Aphasia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Depressed level of consciousness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0042 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Hydrocephalus
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Seizure
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Somnolence
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Normocytic anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Cushingoid
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Chalazion
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Eye disorder
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Lacrimation increased
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Visual acuity reduced
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Visual impairment
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Anal incontinence
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0072 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0041 affected3 at risk
EG0052 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0032 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Catheter site thrombosis
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Chills
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Device related thrombosis
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0013 affected3 at risk
EG0022 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0073 affected5 at risk
EG0081 affected1 at risk
EG0091 affected1 at risk
Gait disturbance
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Mucosal inflammation
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected4 at risk
EG0041 affected3 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Cytokine release syndrome
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Immune system disorder
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Bronchitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Catheter site infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Device related infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Skin infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Urinary tract infection bacterial
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Urinary tract infection staphylococcal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Vascular device infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Viral infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Wound infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Alanine aminotransferase abnormal
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0072 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Aspartate aminotransferase abnormal
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0072 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Blood bilirubin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
C-reactive protein increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
CD4 lymphocytes decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Interleukin level increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Lipase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Lymphocyte count abnormal
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Lymphocyte count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
White blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
White blood cell count increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0052 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hyperchloraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0072 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypouricaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Metabolic disorder
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0072 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Amnesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Aphasia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0032 affected4 at risk
EG0042 affected3 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Ataxia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Balance disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Brain oedema
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Cognitive disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Depressed level of consciousness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dysarthria
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dyskinesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Dysmetria
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Epilepsy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0012 affected3 at risk
EG0022 affected3 at risk
EG0032 affected4 at risk
EG0042 affected3 at risk
EG0052 affected4 at risk
EG0063 affected4 at risk
EG0074 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Hemianopia homonymous
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hemiparesis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hydrocephalus
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypersomnia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0081 affected1 at risk
EG0090 affected1 at risk
Hypokinesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Language disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Lethargy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Memory impairment
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Paraesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pyramidal tract syndrome
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Seizure
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0031 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0072 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Somnolence
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0042 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Device malfunction
Product Issues
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Bradyphrenia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Confusional state
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Depressed mood
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Depression
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Disorientation
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Bladder spasm
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Haematuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Polyuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Purpura
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0041 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0052 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Haematoma
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hot flush
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0091 affected1 at risk
Hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Phlebitis superficial
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Thrombophlebitis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected4 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected5 at risk
EG0080 affected1 at risk
EG0090 affected1 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D009375
Neoplasms, Glandular and Epithelial
D009380
Neoplasms, Nerve Tissue
3
BG0054
BG0064
BG0075
BG0081
BG0091
BG01028
1
BG0050
BG0060
BG0070
BG0080
BG0090
BG0102
3
BG0053
BG0063
BG0075
BG0080
BG0090
BG01020
3
BG0054
BG0064
BG0075
BG0081
BG0091
BG01029
1
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
0
BG0051
BG0060
BG0070
BG0080
BG0090
BG0102
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
3
BG0053
BG0064
BG0072
BG0081
BG0091
BG01024
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
1
BG0050
BG0060
BG0073
BG0080
BG0090
BG0104
4
OG0043
OG0054
OG0064
OG0075
OG0081
OG0091
4
OG0043
OG0053
OG0064
OG0075
OG0081
OG0091
4
OG0043
OG0054
OG0064
OG0075
OG0081
OG0091
3
OG0043
OG0052
OG0064
OG0074
OG0081
OG0091
4
OG0043
OG0054
OG0064
OG0075
OG0081
OG0091
4
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0081
ParticipantsOG0091
Title
Measurements
OG0000.733(0.733 to 0.733)
OG0011.90(1.87 to 1.93)
OG0023.38(3.28 to 3.47)
OG0039.53(2.98 to 14.0)
OG00426.7(22.4 to 29.8)
OG00567.1(45.9 to 89.0)
OG006106(72.5 to 136)
OG007180(103 to 222)
OG008610(610 to 610)
OG00919.4(19.4 to 19.4)
Cycle 2
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0090
Title
Measurements
OG0000.548(0.548 to 0.548)
OG0011.48(0.872 to 2.51)
OG0023.37(2.81 to 3.93)
OG003
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
3
OG0043
OG0054
OG0064
OG0074
OG0081
OG0091
3
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0081
ParticipantsOG0091
Title
Measurements
OG0000.0324(0.0324 to 0.0324)
OG0010.0116(0.0102 to 0.0130)
OG0020.0172(0.0122 to 0.0200)
OG0030.0207(0.0161 to 0.0294)
OG0040.0272(0.0244 to 0.0309)
OG0050.0237(0.0188 to 0.0322)
OG0060.0218(0.0171 to 0.0308)
OG0070.0291(0.0197 to 0.0464)
OG0080.0146(0.0146 to 0.0146)
OG0090.158(0.158 to 0.158)
Cycle 2
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0090
Title
Measurements
OG0000.0469(0.0469 to 0.0469)
OG0010.0175(0.00910 to 0.0259)
OG0020.0232(0.0232 to 0.0232)
OG003
3
OG0043
OG0054
OG0064
OG0074
OG0081
OG0091
3
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0081
ParticipantsOG0091
Title
Measurements
OG0000.269(0.269 to 0.269)
OG0010.0961(0.0637 to 0.128)
OG0020.173(0.125 to 0.213)
OG0030.247(0.198 to 0.325)
OG0040.200(0.155 to 0.280)
OG0050.212(0.109 to 0.278)
OG0060.205(0.155 to 0.268)
OG0070.269(0.185 to 0.387)
OG0080.166(0.166 to 0.166)
OG0091.61(1.61 to 1.61)
Cycle 2
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0090
Title
Measurements
OG0000.289(0.289 to 0.289)
OG0010.162(0.0929 to 0.232)
OG0020.246(0.246 to 0.246)
OG003
3
OG0043
OG0054
OG0064
OG0074
OG0081
OG0091
3
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0081
ParticipantsOG0091
Title
Measurements
OG0005.75(5.75 to 5.75)
OG0015.59(4.34 to 6.84)
OG0026.98(6.42 to 7.39)
OG0038.44(7.66 to 9.10)
OG0045.02(4.37 to 6.29)
OG0056.16(3.96 to 7.49)
OG0066.67(5.31 to 8.51)
OG0076.54(5.77 to 7.23)
OG0087.90(7.90 to 7.90)
OG0097.04(7.04 to 7.04)
Cycle 2
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0090
Title
Measurements
OG0004.27(4.27 to 4.27)
OG0016.64(6.21 to 7.07)
OG0027.33(7.33 to 7.33)
OG003
4
OG0043
OG0054
OG0063
OG0075
OG0081
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
OG0043
OG0054
OG0064
OG0075
OG0081
OG0091
1.9
(1.2 to NA)
Values are not evaluable as the upper limit was not reached.
OG0032.6(2.4 to NA)Values are not evaluable as the upper limit was not reached.
OG0041.2(0.1 to NA)Values are not evaluable as the upper limit was not reached.
OG0051.7(1.0 to NA)Values are not evaluable as the upper limit was not reached.
OG0062.4(1.2 to NA)Values are not evaluable as the upper limit was not reached.
OG0077.0(1.3 to NA)Values are not evaluable as the upper limit was not reached.
OG0085.3(NA to NA)Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
OG0092.6(NA to NA)Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
4
OG0043
OG0054
OG0064
OG0075
OG0081
OG0091
1.9
(1.2 to NA)
Upper confidence limit could not be calculated due to the low number of events reported.
OG0032.6(2.4 to NA)Upper confidence limit could not be calculated due to the low number of events reported.
OG0041.2(0.1 to NA)Upper confidence limit could not be calculated due to the low number of events reported.
OG0051.7(1.0 to NA)Upper confidence limit could not be calculated due to the low number of events reported.
OG0062.4(1.2 to NA)Upper confidence limit could not be calculated due to the low number of events reported.
OG0075.8(1.3 to NA)Upper confidence limit could not be calculated due to the low number of events reported.
OG0085.3(NA to NA)Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.
OG0092.6(NA to NA)Only 1 participant in the treatment arm, therefore confidence intervals cannot be calculated.