A Study to Evaluate the Safety, Tolerability, Pharmacokin... | NCT02541604 | Trialant
NCT02541604
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
Feb 25, 2020Actual
Enrollment
87Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumor
Interventions
Atezolizumab
Countries
United States
Canada
Denmark
France
Germany
Israel
Italy
Netherlands
Spain
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02541604
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GO29664
Secondary IDs
ID
Type
Description
Link
2014-004697-41
EudraCT Number
Brief Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors
Official Title
An Early-Phase, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) In Pediatric and Young Adult Patients With Previously Treated Solid Tumors
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Feb 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision to terminate because limited investigational agent activity was observed.
Expanded Access Info
No
Start Date
Nov 30, 2015Actual
Primary Completion Date
Jun 6, 2019Actual
Completion Date
Jun 6, 2019Actual
First Submitted Date
Aug 18, 2015
First Submission Date that Met QC Criteria
Sep 3, 2015
First Posted Date
Sep 4, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 11, 2019
Results First Submitted that Met QC Criteria
Feb 24, 2020
Results First Posted Date
Feb 25, 2020Actual
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
Feb 24, 2020
Last Update Posted Date
Feb 25, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This early phase, multicenter, open-label, single-arm study evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of atezolizumab in pediatric and young adult participants with solid tumors for which prior treatment was proven to be ineffective.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumor
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
87Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Atezolizumab
Experimental
Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Drug: Atezolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Atezolizumab
Drug
Atezolizumab was administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle.
Atezolizumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants With Solid Tumors
Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) in Participants With Neuroblastoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Response Assessment in Neuro-Oncology (RANO) Criteria in Participants With Atypical Teratoid Rhabdoid Tumor (ATRT)
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
DOR as Determined by the Investigator Using mINRC in Participants With Neuroblastoma
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Pediatric solid tumor (including Hodgkin's and Non-Hodgkin's lymphoma), for which prior treatment had proven to be ineffective (that is, relapsed or refractory) or intolerable
Disease that is measurable as defined by RECIST v1.1, mINRC, Revised Response Criteria for Malignant Lymphoma, RANO criteria (as appropriate) or evaluable by nuclear medicine techniques, immunocytochemistry techniques, tumor markers, or other reliable measures
Archival tumor tissue block or 15 freshly cut, unstained, serial slides available for submission, or willingness to undergo a core or excisional biopsy prior to enrollment (fine-needle aspiration, brush biopsy, and lavage samples are not acceptable).
Participants with fewer than 15 slides available may be eligible for study entry following discussion with Medical Monitor
Lansky Performance Status (participants less than [<] 16 years old) or Karnofsky Performance Status (participants greater than or equal to [>=] 16 years old) >=50
Life expectancy >=3 months, in the investigator's judgment
Adequate hematologic and end organ function, confirmed by laboratory results obtained within 28 days prior to initiation of study drug
Exclusion Criteria:
Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases, except ATRT
Treatment with high-dose chemotherapy and hematopoietic stem-cell rescue within 3 months prior to initiation of study drug
Prior allogeneic hematopoietic stem-cell transplantation or prior solid-organ transplantation
Treatment with chemotherapy (other than high-dose chemotherapy as described above) or differentiation therapy (such as retinoic acid) or immunotherapy (such as anti-GD2 antibody treatment) within 3 weeks prior to initiation of study drug or, if treatment included nitrosoureas, within 6 weeks prior to initiation of study drug
Treatment with thoracic or mediastinal radiotherapy within 3 weeks prior to initiation of study drug
Treatment with hormonal therapy (except hormone replacement therapy or oral contraceptives) or biologic therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to initiation of study drug. This requirement may be waived at the investigator's request if the participant has recovered from therapeutic toxicity to the degree specified in the protocol, with approval of the Medical Monitor
Treatment with a long-acting hematopoietic growth factor within 2 weeks prior to initiation of study drug or a short-acting hematopoietic growth factor within 1 week prior to initiation of study drug
Treatment with investigational therapy (with the exception of cancer therapies as described above) within 4 weeks prior to initiation of study drug
Treatment with a live vaccine or a live, attenuated vaccine (e.g., nasal spray of live attenuated influenza vaccine or FluMist®) within 4 weeks prior to initiation of study drug or anticipation that such treatment will be required during the study or within 5 months after the final dose of study drug
Treatment with herbal cancer therapy within 1 week prior to initiation of study drug
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4), anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin 2 [IL-2]) within 6 weeks or five drug elimination half-lives prior to Day 1 of Cycle 1, whichever is longer
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) at the time of initiation of study drug, or anticipated requirement for systemic immunosuppressive medications during the study
Current treatment with therapeutic anticoagulants
Any non-hematologic toxicity (excluding alopecia) from prior treatment that has not resolved to Grade less than or equal to (<=) 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) at screening
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma
Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
PFS as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT
Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
From baseline up to approximately 42 months
Maximum Serum Concentration (Cmax) of Atezolizumab
Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days)
Minimum Serum Concentration (Cmin) of Atezolizumab
PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 42 months)
Atezolizumab Serum Concentration at Washout
At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)
Area Under the Concentration-Time Curve (AUC) of Atezolizumab
PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (1 Cy=21 days)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
DOR as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
DOR as Determined by the Investigator Using RANO Criteria in Participants With ATRT
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Overall Survival (OS)
Baseline until death (up to approximately 42 months)
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Related Response Criteria (irRC) for Participants With Neuroblastoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
DOR as Determined by the Investigator Using irRC for Participants With Neuroblastoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Optimal Dose of Atezolizumab in Pediatric Adult Participants
Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
From baseline up to approximately 42 months
Optimal Dose of Atezolizumab in Young Adult Participants
Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
From baseline up to approximately 42 months
Palo Alto
California
94304
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Penn State Milton S. Hershey Medical Center
Hershey
Pennsylvania
17033
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
University of Texas Health Science Center at San Antonio
San Antonio
Texas
78229
United States
Alberta Children'S Hospital
Calgary
Alberta
T3B 6A8
Canada
Rigshospitalet; BØRNEUNGEKLINIKKEN, Ambulatoriet for kræft- og Blodsygdomme hos børn og unge
København Ø
2100
Denmark
Centre Léon Bérard, Institut d'Hémato-Oncologie Pédiatrique
Lyon
69373
France
Institut Curie, Oncologie Pédiatrique
Paris
75231
France
Institut Gustave Roussy; Service Pediatrique
Villejuif
94805
France
Klinik Johann Wolfgang von Goethe Uni
Frankfurt
60590
Germany
Schneider Children's Medical Center
Petah Tikva
49100
Israel
Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica
Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica
Milan
Lombardy
20133
Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Turin
Piedmont
10126
Italy
Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica
Padova
Veneto
35128
Italy
Erasmus MC / location Sophia Kinderziekenhuis
Rotterdam
3015 GJ
Netherlands
Hospital Sant Joan De Deu
Esplugues de Llobregas
Barcelona
08950
Spain
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Hospital Infantil Universitario Nino Jesus
Madrid
28009
Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
46026
Spain
Universitäts-Kinderspital; Abteilung für Onkologie
Zurich
8032
Switzerland
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
Bristol Royal Hospital For Children
Bristol
BS2 8BJ
United Kingdom
Leeds General Infirmary; Paediatric Oncology & Haematology
Leeds
LS1 3EX
United Kingdom
The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit
Newcastle upon Tyne
NE1 4LP
United Kingdom
Royal Marsden Hospital; Pediatric Unit
Surrey
SM2 5PT
United Kingdom
Derived
Geoerger B, Zwaan CM, Marshall LV, Michon J, Bourdeaut F, Casanova M, Corradini N, Rossato G, Farid-Kapadia M, Shemesh CS, Hutchinson KE, Donaldson F, Liao M, Caron H, Trippett T. Atezolizumab for children and young adults with previously treated solid tumours, non-Hodgkin lymphoma, and Hodgkin lymphoma (iMATRIX): a multicentre phase 1-2 study. Lancet Oncol. 2020 Jan;21(1):134-144. doi: 10.1016/S1470-2045(19)30693-X. Epub 2019 Nov 25.
Shemesh CS, Chanu P, Jamsen K, Wada R, Rossato G, Donaldson F, Garg A, Winter H, Ruppel J, Wang X, Bruno R, Jin J, Girish S. Population pharmacokinetics, exposure-safety, and immunogenicity of atezolizumab in pediatric and young adult patients with cancer. J Immunother Cancer. 2019 Nov 21;7(1):314. doi: 10.1186/s40425-019-0791-x.
COHORT 3
NEUROBLASTOMA
FG003
COHORT 4
NON HODGKIN LYMPHOMA
FG004
COHORT 5
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
FG005
COHORT 6
OSTEOSARCOMA
FG006
COHORT 7
RHABDOMYOSARCOMA
FG007
COHORT 8
WILMS TUMOR
FG008
COHORT 9
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
FG009
COHORT 10
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
FG010
COHORT 11
RHABDOID TUMOR
FG011
COHORT 12
ATYPICAL TERATOID RHABDOID TUMOR
FG00011 subjects
FG0019 subjects
FG00211 subjects
FG0033 subjects
FG00410 subjects
FG00510 subjects
FG00610 subjects
FG00710 subjects
FG0084 subjects
FG0094 subjects
FG0102 subjects
FG0113 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG00011 subjects
FG0019 subjects
FG00211 subjects
FG0033 subjects
FG00410 subjects
FG00510 subjects
FG00610 subjects
FG00710 subjects
FG0084 subjects
FG0094 subjects
FG0102 subjects
FG0113 subjects
Type
Comment
Reasons
Death
FG0006 subjects
FG0015 subjects
FG0027 subjects
FG0032 subjects
FG0049 subjects
FG0058 subjects
FG0069 subjects
FG0079 subjects
FG0083 subjects
FG0094 subjects
FG0102 subjects
FG0113 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0001 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG004
Medical condition may jeopardize safety
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
COHORT 1
EWING SARCOMA
BG001
COHORT 2
HODGKIN LYMPHOMA
BG002
COHORT 3
NEUROBLASTOMA
BG003
COHORT 4
NON HODGKIN LYMPHOMA
BG004
COHORT 5
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
BG005
COHORT 6
OSTEOSARCOMA
BG006
COHORT 7
RHABDOMYOSARCOMA
BG007
COHORT 8
WILMS TUMOR
BG008
COHORT 9
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
BG009
COHORT 10
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
BG010
COHORT 11
RHABDOID TUMOR
BG011
COHORT 12
ATYPICAL TERATOID RHABDOID TUMOR
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG0019
BG00211
BG0033
BG00410
BG00510
BG00610
BG00710
BG0084
BG0094
BG0102
BG0113
BG01287
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00013.6± 3.3
BG00114.2± 3.0
BG00212.8± 9.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants With Solid Tumors
Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Number
Percentage
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 1
Participants with ewing sarcoma
OG001
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
OG002
Cohort 6
Participants with osteosarcoma.
OG003
Cohort 7
Participants with rhabdomyosarcoma
OG004
Cohort 8
Participants with wilms tumor
OG005
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
OG006
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
OG007
Cohort 11
Participants with rhabdoid tumor.
Units
Counts
Participants
OG00011
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG00110.0
OG0020
OG003
Primary
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) in Participants With Neuroblastoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Number
Percentage
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 3
Participants with neuroblastoma.
Units
Counts
Participants
OG00011
Primary
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Number
Percentage
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 2
Participants with Hodgkin's lymphoma
OG001
Cohort 4
Participants with non-Hodgkin's lymphoma
Units
Counts
Participants
OG000
Primary
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Response Assessment in Neuro-Oncology (RANO) Criteria in Participants With Atypical Teratoid Rhabdoid Tumor (ATRT)
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Number
Percentage
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
Units
Counts
Participants
OG0003
Primary
Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma
Included safety-evaluable population (defined as patients who received any amount of study drug), in the Osteosarcoma cohort as per protocol. (Objective response for the other cohorts are measured with different response criteria, and these are described in Outcome Measures 1, 2, 3, and 4).
Posted
Number
Percentage
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 6
Participants with osteosarcoma.
Units
Counts
Participants
OG000
Primary
Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 1
Participants with ewing sarcoma.
OG001
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
OG002
Cohort 6
Participants with osteosarcoma.
OG003
Cohort 7
Participants with rhabdomyosarcoma.
OG004
Cohort 8
Participants with wilms tumor.
Primary
PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 3
Participants with neuroblastoma.
Units
Counts
Participants
OG00011
Primary
PFS as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 2
Participants with hodgkin's lymphoma.
OG001
Cohort 4
Participants with non-hodgkin's lymphoma.
Units
Counts
Participants
OG000
Primary
PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
Units
Counts
Participants
OG0003
Primary
Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Number
Percentage
From baseline up to approximately 42 months
ID
Title
Description
OG000
Atezolizumab
Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00087
Primary
Maximum Serum Concentration (Cmax) of Atezolizumab
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the "<2 Age (Years)" Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days)
ID
Title
Description
OG000
<2 Age (Years)
Participants <2 Age (Years)
OG001
2 to <12 Age (Years)
Participants 2 to <12 Age (Years)
OG002
12 to <18 Age (Years)
Participants 12 to <18 Age (Years)
OG003
>=18 Age (Years)
Participants >=18 Age (Years)
Primary
Minimum Serum Concentration (Cmin) of Atezolizumab
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the "<2 Age (Years)" Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 42 months)
ID
Title
Description
OG000
<2 Age (Years)
Participants <2 Age (Years)
OG001
2 to <12 Age (Years)
Participants 2 to <12 Age (Years)
OG002
12 to <18 Age (Years)
Participants 12 to <18 Age (Years)
OG003
>=18 Age (Years)
Participants >=18 Age (Years)
Primary
Atezolizumab Serum Concentration at Washout
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)
ID
Title
Description
OG000
Atezolizumab
Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00017
Primary
Area Under the Concentration-Time Curve (AUC) of Atezolizumab
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff.
Posted
Geometric Mean
Geometric Coefficient of Variation
ugxday/mL
PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (1 Cy=21 days)
ID
Title
Description
OG000
<2 Age (Years)
Participants <2 Age (Years)
OG001
2 to <12 Age (Years)
Participants 2 to <12 Age (Years)
OG002
12 to <18 Age (Years)
Participants 12 to <18 Age (Years)
OG003
>=18 Age (Years)
Participants >=18 Age (Years)
Units
Counts
Primary
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
The baseline ADA-evaluable population included patients who had a baseline ADA result. The post-baseline ADA-evaluable population included patients who had at least one post-baseline ADA result and had received at least one dose of that study treatment. Patients never dosed and patients without valid ADA records were not included in the analysis.
Posted
Number
Percentage
PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)
ID
Title
Description
OG000
Atezolizumab
Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG000
Secondary
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 1
Participants with ewing sarcoma
OG001
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma.
OG002
Cohort 6
Participants with osteosarcoma.
OG003
Cohort 7
Participants with rhabdomyosarcoma
OG004
Cohort 8
Participants with wilms tumor.
Secondary
DOR as Determined by the Investigator Using mINRC in Participants With Neuroblastoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 3
Participants with neuroblastoma.
Units
Counts
Participants
OG0000
Secondary
DOR as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 2
Participants with hodgkin lymphoma.
OG001
Cohort 4
Participants with non-hodgkin's lymphoma
Units
Counts
Participants
OG000
Secondary
DOR as Determined by the Investigator Using RANO Criteria in Participants With ATRT
Included safety-evaluable population, defined as patients who received any amount of study drug. No participants had an objective response in this cohort.
Posted
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
Units
Counts
Participants
OG0000
Secondary
Overall Survival (OS)
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until death (up to approximately 42 months)
ID
Title
Description
OG000
Atezolizumab
Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00087
Secondary
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Number
Percentage
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 1
Participants with ewing sarcoma.
OG001
Cohort 5
Participants with non-rhabdomyosarcoma.
OG002
Cohort 6
Participants with osteosarcoma.
OG003
Cohort 7
Participants with rhabdomyosarcoma.
OG004
Cohort 8
Participants with wilms tumor.
Secondary
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Related Response Criteria (irRC) for Participants With Neuroblastoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Number
Percentage
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 3
Participants with neuroblastoma.
Units
Counts
Participants
OG00011
Secondary
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Number
Percentage
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 2
Participants with hodgkin's lymphoma.
OG001
Cohort 4
Participants with non-hodgkin lymphoma.
Units
Counts
Participants
OG000
Secondary
PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 1
Participants with ewing sarcoma.
OG001
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma.
OG002
Cohort 6
Participants with osteosarcoma.
OG003
Cohort 7
Participants with rhabdomyosarcoma.
OG004
Cohort 8
Participants with wilms tumor.
Secondary
PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 3
Participants with neuroblastoma
Units
Counts
Participants
OG00011
Secondary
PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 2
Participants with hodgkin lymphoma
OG001
Cohort 4
Participants with non-hodgkin's lymphoma
Units
Counts
Participants
OG000
Secondary
DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 1
Participants with ewing sarcoma.
OG001
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma.
OG002
Cohort 6
Participants with osteosarcoma.
OG003
Cohort 7
Participants with rhabdomyosarcoma.
OG004
Cohort 8
Participants with wilms tumor.
Secondary
DOR as Determined by the Investigator Using irRC for Participants With Neuroblastoma
Included safety-evaluable population, defined as patients who received any amount of study drug. No participants had response therefore no participants analyzed.
Posted
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 3
Participants with neuroblastoma
Units
Counts
Participants
OG0000
Secondary
DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Included safety-evaluable population, defined as patients who received any amount of study drug.
Posted
Median
95% Confidence Interval
Months
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
ID
Title
Description
OG000
Cohort 2
Participants with Hodgkin lymphoma.
OG001
Cohort 4
Participants with non-hodgkin's lymphoma
Units
Counts
Participants
OG000
Secondary
Optimal Dose of Atezolizumab in Pediatric Adult Participants
Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Posted
Number
mg/kg
From baseline up to approximately 42 months
ID
Title
Description
OG000
<18 Age (Years)
Participants <18 Age (Years)
Units
Counts
Participants
OG00069
Title
Denominators
Categories
Secondary
Optimal Dose of Atezolizumab in Young Adult Participants
Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Posted
Number
mg
From baseline up to approximately 42 months
ID
Title
Description
OG000
>=18 Age (Years)
Participants >=18 Age (Years)
Units
Counts
Participants
OG00018
Title
Denominators
Categories
Time Frame
From baseline up to approximately 42 months
Description
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
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
COHORT 1
EWING SARCOMA
6
11
4
11
11
11
EG001
COHORT 2
HODGKIN LYMPHOMA
5
9
3
9
8
9
EG002
COHORT 3
NEUROBLASTOMA
7
11
2
11
11
11
EG003
COHORT 4
NON HODGKIN LYMPHOMA
2
3
0
3
3
3
EG004
COHORT 5
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
9
10
3
10
10
10
EG005
COHORT 6
OSTEOSARCOMA
8
10
6
10
10
10
EG006
COHORT 7
RHABDOMYOSARCOMA
9
10
3
10
10
10
EG007
COHORT 8
WILMS TUMOR
9
10
5
10
10
10
EG008
COHORT 9
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
3
4
2
4
4
4
EG009
COHORT 10
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
4
4
3
4
3
4
EG010
COHORT 11
RHABDOID TUMOR
2
2
1
2
2
2
EG011
COHORT 12
ATYPICAL TERATOID RHABDOID TUMOR
3
3
1
3
2
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected10 at risk
EG0071 events1 affected10 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected2 at risk
EG0110 events0 affected3 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PAPILLOEDEMA
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LARGE INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CHEST PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
FATIGUE
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PYREXIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
CHOLESTASIS
Hepatobiliary disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
GRAFT VERSUS HOST DISEASE
Immune system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ABDOMINAL ABSCESS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
INCISION SITE ABSCESS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
POSTOPERATIVE ABSCESS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SEPTIC SHOCK
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
STAPHYLOCOCCAL SEPSIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
POSTOPERATIVE HYPOTENSION
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
TOXICITY TO VARIOUS AGENTS
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
DIABETIC KETOACIDOSIS
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYDROCEPHALUS
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VITH NERVE DISORDER
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYDRONEPHROSIS
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
URINARY TRACT OBSTRUCTION
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
TOXIC SKIN ERUPTION
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SHOCK HAEMORRHAGIC
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SUPERIOR VENA CAVA SYNDROME
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events3 affected11 at risk
EG0011 events1 affected9 at risk
EG0026 events3 affected11 at risk
EG0031 events1 affected3 at risk
EG00412 events5 affected10 at risk
EG0052 events2 affected10 at risk
EG0063 events3 affected10 at risk
EG0072 events2 affected10 at risk
EG0081 events1 affected4 at risk
EG0091 events1 affected4 at risk
EG0101 events1 affected2 at risk
EG0111 events1 affected3 at risk
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0003 events2 affected11 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected11 at risk
EG003
THROMBOCYTOSIS
Blood and lymphatic system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PERICARDIAL EFFUSION
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
FANCONI SYNDROME
Congenital, familial and genetic disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0013 events2 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPERTHYROIDISM
Endocrine disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events2 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPOTHYROIDISM
Endocrine disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ECZEMA EYELIDS
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
EYELID PTOSIS
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
OPSOCLONUS MYOCLONUS
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
PERIORBITAL OEDEMA
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PHOTOPHOBIA
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PHOTOPSIA
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0003 events3 affected11 at risk
EG0012 events2 affected9 at risk
EG0022 events2 affected11 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ANAL INCONTINENCE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0006 events3 affected11 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected11 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events2 affected9 at risk
EG0025 events4 affected11 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ENTEROCOLITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HAEMATOCHEZIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
LIP ULCERATION
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events4 affected11 at risk
EG0013 events1 affected9 at risk
EG0022 events1 affected11 at risk
EG003
NONINFECTIVE GINGIVITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ODYNOPHAGIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PROCTALGIA
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
RECTAL DISCHARGE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SUBILEUS
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SWOLLEN TONGUE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events3 affected11 at risk
EG0016 events3 affected9 at risk
EG0022 events2 affected11 at risk
EG003
ASTHENIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
AXILLARY PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
CATHETER SITE ERYTHEMA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CHEST PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected11 at risk
EG003
CHILLS
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
FACE OEDEMA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
FATIGUE
General disorders
MedDRA version 22.0
Systematic Assessment
EG0003 events2 affected11 at risk
EG0012 events2 affected9 at risk
EG0023 events3 affected11 at risk
EG003
GENERALISED OEDEMA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected11 at risk
EG003
MALAISE
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
OEDEMA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PAIN
General disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PYREXIA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0005 events3 affected11 at risk
EG0019 events3 affected9 at risk
EG0025 events4 affected11 at risk
EG003
THIRST
General disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VACCINATION SITE OEDEMA
General disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CANDIDA URETHRITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DERMATOPHYTOSIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
GENITAL HERPES
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HERPES VIRUS INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
PARONYCHIA
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
RHINITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG00116 events4 affected9 at risk
EG0022 events2 affected11 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
STAPHYLOCOCCAL
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected11 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VASCULAR DEVICE INFECTION
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VULVITIS
Infections and infestations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
POST PROCEDURAL SWELLING
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
UROSTOMY COMPLICATION
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
WOUND DEHISCENCE
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0013 events1 affected9 at risk
EG0023 events3 affected11 at risk
EG003
AMYLASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ANTITHROMBIN III DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events1 affected9 at risk
EG0024 events4 affected11 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BLOOD CHLORIDE DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BLOOD LACTATE DEHYDROGENASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BLOOD POTASSIUM DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BLOOD THYROID STIMULATING HORMONE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BLOOD URINE PRESENT
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
C-REACTIVE PROTEIN INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CANDIDA TEST POSITIVE
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CARDIAC MURMUR
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
INTERNATIONAL NORMALISED RATIO INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LIPASE INCREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
NOROVIRUS TEST POSITIVE
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
OXYGEN SATURATION DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PROTHROMBIN LEVEL DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VITAMIN K DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA version 22.0
Systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected11 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events4 affected11 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected11 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
HYPERNATRAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
METABOLIC ACIDOSIS
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected11 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0023 events2 affected11 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HAEMARTHROSIS
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected11 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected11 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events2 affected11 at risk
EG0012 events1 affected9 at risk
EG0022 events2 affected11 at risk
EG003
PAIN IN JAW
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
TUMOUR INFLAMMATION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
AMPUTATION STUMP PAIN
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0018 events1 affected9 at risk
EG0023 events3 affected11 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
MIGRAINE WITH AURA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
NEURALGIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PHANTOM LIMB SYNDROME
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
TREMOR
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DEVICE BREAKAGE
Product Issues
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
BRUXISM
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DELIRIUM
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
IRRITABILITY
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SLEEP DISORDER
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
GLYCOSURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
HYDRONEPHROSIS
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
OLIGURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VAGINAL DISCHARGE
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CATARRH
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0004 events3 affected11 at risk
EG00114 events4 affected9 at risk
EG0022 events2 affected11 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
IRREGULAR BREATHING
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
LARYNGEAL INFLAMMATION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected11 at risk
EG003
DISORDER OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PHARYNGEAL INFLAMMATION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected11 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
STRIDOR
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
TACHYPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
BLISTER
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected9 at risk
EG0021 events1 affected11 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PALMAR-PLANTAR
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ERYTHRODYSAESTHESIA SYNDROME
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PERIORAL DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PETECHIAE
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PITYRIASIS ROSEA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
SKIN DISCOLOURATION
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CENTRAL VENOUS CATHETERISATION
Surgical and medical procedures
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
EMBOLISM
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
HYPOVOLAEMIC SHOCK
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
VENOUS THROMBOSIS
Vascular disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
HYPERMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0023 events1 affected11 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
PARAPARESIS
Nervous system disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
ABNORMAL BEHAVIOUR
Psychiatric disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA version 22.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
ATELECTASIS
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected11 at risk
EG003
OBSTRUCTIVE AIRWAYS DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected9 at risk
EG0020 events0 affected11 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA version 22.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected11 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.