A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
Official Title
Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma
Acronym
Cassiopeia
Organization
Intergroupe Francophone du MyelomeNETWORK
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2015Actual
Primary Completion Date
Aug 27, 2020Actual
Completion Date
Sep 1, 2023Actual
First Submitted Date
Jun 24, 2015
First Submission Date that Met QC Criteria
Sep 1, 2015
First Posted Date
Sep 4, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 5, 2024
Results First Submitted that Met QC Criteria
Mar 26, 2025
Results First Posted Date
Apr 13, 2025Actual
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
Mar 26, 2025
Last Update Posted Date
Apr 13, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Intergroupe Francophone du MyelomeNETWORK
Collaborators
Name
Class
HOVON - Dutch Haemato-Oncology Association
OTHER
Janssen Research & Development, LLC
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.
Detailed Description
This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 2-arm (2 treatment groups), multicenter study of daratumumab in participants diagnosed with previously untreated Multiple Myeloma who are eligible for high dose chemotherapy and autologous stem cell transplantation (transplantation of own bone marrow). Participants will be randomized (assigned by chance) to one of 2 treatment groups to either receive daratumumab plus bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone for induction (before transplantation) and consolidation (after transplantation) treatment. All responders will then be re-randomized (assigned by chance) to one of 2 treatment groups to receive maintenance treatment with daratumumab only or observation (no treatment). The study will include a 28-Day Screening Phase, a Treatment Phase of 6 treatment cycles (each cycle is 4 weeks in duration for total period of 30 weeks), and a Follow up Phase of 2 years. The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately 5 years after the last participant is randomized in the second phase of the study. Disease assessments will be performed every 4 weeks in the first phase of the study and then every 8 weeks in the second phase of the study. Safety will be monitored throughout the study.
Conditions Module
Conditions
Multiple Myeloma
Keywords
Untreated Multiple Myeloma
daratumumab
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,085Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A Part 1
Other
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Drug: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Arm B Part 1
Experimental
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Drug
Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT.
According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT
Progression Free Survival (PFS) Post Completion of Maintenance Therapy
Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the completion of Maintenance therapy.
From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).
Secondary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS) From First Randomization up to the End of the Study
Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study
From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of previously untreated multiple myeloma (MM)
Have a confirmed diagnosis and eligible for high dose chemotherapy and autologous stem cell transplantation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2
Exclusion Criteria:
previous treatment for Multiple Myeloma
Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma
Prior or concurrent exposure to systemic therapy or SCT (Stem Cell Transplantation) for any plasma cell dyscrasia, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment, or received an investigational drug or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
history of malignancy (other than Multiple Myeloma) within 10 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
known chronic obstructive pulmonary disease (COPD) or moderate to severe asthma
any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.
FG001
DVTd Only * Arm/Group Title: Characters Remaining: 91
Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Bene MC, Zweegman S, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Stoppa AM, van de Donk NWCJ, Wuilleme S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Krevvata M, Zhang K, de Boer C, Vara S, Kampfenkel T, Vanquickelberghe V, Vermeulen J, Avet-Loiseau H, Sonneveld P. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Oct;22(10):1378-1390. doi: 10.1016/S1470-2045(21)00428-9. Epub 2021 Sep 13.
Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Zweegman S, Caillon H, Caillot D, Avet-Loiseau H, Delforge M, Dejoie T, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Schiano de Colella JM, van de Donk NW, Wuilleme S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Hua W, Wang J, Tuozzo A, de Boer C, Rowe M, Vanquickelberghe V, Carson R, Vermeulen J, Corre J, Sonneveld P; Intergroupe Francophone du Myelome, the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and the CASSIOPEIA Investigators. Bortezomib, thalidomide, and dexamethasone with or without daratumumab and followed by daratumumab maintenance or observation in transplant-eligible newly diagnosed multiple myeloma: long-term follow-up of the CASSIOPEIA randomised controlled phase 3 trial. Lancet Oncol. 2024 Aug;25(8):1003-1014. doi: 10.1016/S1470-2045(24)00282-1. Epub 2024 Jun 15.
Roussel M, Moreau P, Hebraud B, Laribi K, Jaccard A, Dib M, Slama B, Dorvaux V, Royer B, Frenzel L, Zweegman S, Klein SK, Broijl A, Jie KS, Wang J, Vanquickelberghe V, de Boer C, Kampfenkel T, Gries KS, Fastenau J, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab for transplantation-eligible patients with newly diagnosed multiple myeloma (CASSIOPEIA): health-related quality of life outcomes of a randomised, open-label, phase 3 trial. Lancet Haematol. 2020 Dec;7(12):e874-e883. doi: 10.1016/S2352-3026(20)30356-2.
All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.
FG002
VTd-OBS
All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation
FG003
VTd-DARA
All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy
FG004
DVTd-OBS
All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation.
FG005
DVTd-DARA
All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy.
FG000114 subjects
FG00185 subjects
FG002215 subjects
FG003213 subjects
FG004229 subjects
FG005229 subjects
COMPLETED
FG00053 subjects
FG00138 subjects
FG002165 subjects
FG003170 subjects
FG004205 subjects
FG005204 subjects
NOT COMPLETED
FG00061 subjects
FG00147 subjects
FG00250 subjects
FG00343 subjects
FG00424 subjects
FG00525 subjects
Type
Comment
Reasons
Death
FG00050 subjects
FG00137 subjects
FG00248 subjects
FG00341 subjects
FG00421 subjects
FG00525 subjects
Lost to Follow-up
FG0005 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
Consent withdrawn
FG0005 subjects
FG0016 subjects
FG0021 subjects
FG0031 subjects
FG004
Sponsor's decision
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
VTd Only
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), not re-randomized in maintenance phase
BG001
DVTd Only
Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), not re-randomized in maintenance phase
BG002
VTd-OBS
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to observation
BG003
VTd-DARA
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to daratumumab monotherapy
BG004
DVTd-OBS
Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to observation
BG005
DVTd-DARA
Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to daratumumab monotherapy
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000114
BG00185
BG002215
BG003213
BG004229
BG005229
BG0061085
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
ParticipantsBG000114
ParticipantsBG00185
ParticipantsBG002215
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000114
ParticipantsBG00185
ParticipantsBG002
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
BELGIUM
ParticipantsBG000114
ParticipantsBG00185
ParticipantsBG002
Baseline ISS Stage
The International Staging System (ISS) for Multiple Myeloma was established by the International Myeloma Working Group (IMWG) in 2005. Sβ2M = Serum β2 microglobulin.
Stage I is defined by Sβ2M < 3.5 mg/L and serum albumin ≥ 3.5 g/dL - Stage II is defined by Sβ2M < 3.5 mg/L and serum albumin < 3.5 g/dL; or β2M ≥ 3.5 mg/L and < 5.5 mg/L, irrespective of serum albumin - Stage III is defined by Sβ2M ≥ 5.5 mg/L Stage I is considered to have a better prognosis and stage III a worse prognosis.
Number
participants
Title
Denominators
Categories
I
ParticipantsBG000114
ParticipantsBG00185
Baseline Type of Myeloma
Multiple myeloma has different types of monoclonal proteins. These types are based on the immunoglobulin (protein) produced by the myeloma cell and they are identified by immunofixation method. The five types of heavy protein chains are G, A, D, E, and M.
The two types of light protein chains are kappa (κ) and lambda (λ). The myeloma cells may secrete heavy and light protein chains (i.e. IgG Kappa) but also only light protein chains.
Row "Biclonal" = the myeloma cells (plasmocytes) produce two immunoglobulins with heavy chains - Row "negative immunofixation" = absence of monoclonal proteins
Number
participants
Title
Denominators
Categories
Biclonal
ParticipantsBG000114
ParticipantsBG001
Time since initial diagnosis to randomization (months)
Mean
Standard Deviation
months
Title
Denominators
Categories
ParticipantsBG000114
ParticipantsBG00185
ParticipantsBG002
Presence of diffuse myeloma-related osteopenia
Number
participants
Title
Denominators
Categories
No
ParticipantsBG000114
ParticipantsBG00185
ParticipantsBG002
Presence of evaluable bone marrow assessment
Number
participants
Title
Denominators
Categories
No
ParticipantsBG000114
ParticipantsBG00185
ParticipantsBG002
Bone marrow cellularity
A sample of bone marrow aspirate was analyzed to count the cells and assess the cellular richness
Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT.
According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
All participants randomized in the first randomization.
Posted
Count of Participants
Participants
At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT
ID
Title
Description
OG000
Arm A Part 1
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD): Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
OG001
Arm B Part 1
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab
Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab: Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Units
Counts
Participants
OG000542
OG001543
Title
Denominators
Categories
Title
Measurements
OG000110
OG001157
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0010
Odds Ratio (OR)
1.6
2-Sided
95
1.21
2.12
Superiority
Primary
Progression Free Survival (PFS) Post Completion of Maintenance Therapy
Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the completion of Maintenance therapy.
All participants randomized in the second randomization even if they did not receive any study treatment dose.
Posted
Median
95% Confidence Interval
Months
From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).
ID
Title
Description
OG000
Arm A Part 2
All patients randomized to the Observation group at rando 2 (whatever the treatment allocated at rando 1)
OG001
Arm B Part 2
All patients randomized to the Daratumumab group at rando 2 even those who didn't receive any treatment dose (whatever the treatment allocated at rando 1).
Daratumumab: Daratumumab 16mg/kg every 8 weeks for 2 years
Units
Counts
Secondary
Progression Free Survival (PFS) From First Randomization up to the End of the Study
Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study
All participants randomized in the first randomization even if they did not receive any study treatment dose.
Posted
Median
95% Confidence Interval
Months
From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study
ID
Title
Description
OG000
Arm A - Part 1 up to End of Study
All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) even those who didn't receive any treatment dose.
OG001
Arm B - Part 1 up to End of Study
All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) even those who didn't receive any treatment dose.
Time Frame
AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study.
Description
VTd & DVTd (Part 1) arms contain the SAEs/AEs considered treatment emergent (TEAE) to Part 1 only from the 1st dose and before 2nd rando or subsequent therapy (ST), or after 2nd rando if TEAE related to the Part 1 treatment.
VTd-DARA & DVTd-DARA (Part 2) arms include SAEs/AEs considered TEAE to Part 2, from the 2nd rando up to 30 days after the last dose prior to ST.
VTd-OBS & DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
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
VTd - Part 1
All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) and who received at least one dose of treatment.
It includes deaths that occurred from the 1st randomization to the end of the study.
For the all-cause mortality report, the at risk population also includes the patients randomized but who didn't receive any treatment.
139
542
261
538
529
538
EG001
DVTd - Part 1
All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) and who received at least one dose of treatment.
It includes deaths that occurred from the 1st randomization to the end of the study.
For the all-cause mortality report, the at risk population also includes the patients randomized but who didn't receive any treatment.
83
543
264
536
534
536
EG002
VTd-OBS - Part 2
All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to observation group (OBS) at rando 2.
It includes deaths that occurred from the 2nd randomization to the end of the study.
That means that all deaths reported in this arm are also reported in the arm VTd - Part 1.
48
215
35
215
170
215
EG003
VTd-DARA - Part 2
All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to daratumumab group (DARA) at rando 2 and who received at least one dose of treatment after Rando 2.
It includes deaths that occurred from the 2nd randomization to the end of the study.
That means that all deaths reported in this arm are also reported in the arm VTd - Part 1.
41
211
58
211
194
211
EG004
DVTd-OBS - Part 2
All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to observation group (OBS) at rando 2.
It includes deaths that occurred from the 2nd randomization to the end of the study.
That means that all deaths reported in this arm are also reported in the arm DVTd - Part 1.
21
229
50
229
198
229
EG005
DVTd-DARA - Part 2
All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to daratumumab group (DARA) at rando 2 and who received at least one dose of treatment after Rando 2.
It includes deaths that occurred from the 2nd randomization to the end of the study.
That means that all deaths reported in this arm are also reported in the arm DVTd - Part 1.
25
229
43
229
205
229
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Agranulocytosis
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG0030 affected211 at risk
EG004
Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Febrile Bone Marrow Aplasia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG00012 affected538 at risk
EG0017 affected536 at risk
EG0020 affected215 at risk
EG003
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG00016 affected538 at risk
EG00112 affected536 at risk
EG0020 affected215 at risk
EG003
Haemolytic Uraemic Syndrome
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Histiocytosis Haematophagic
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0017 affected536 at risk
EG0020 affected215 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0008 affected538 at risk
EG00122 affected536 at risk
EG0020 affected215 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0004 affected538 at risk
EG00112 affected536 at risk
EG0021 affected215 at risk
EG003
Thrombotic Microangiopathy
Blood and lymphatic system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Acute Coronary Syndrome
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Arrhythmia Supraventricular
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0006 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Atrial Tachycardia
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Atrioventricular Block
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cardiac Amyloidosis
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0005 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Cardiac Failure Acute
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Coronary Artery Stenosis
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Mitral Valve Prolapse
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Paroxysmal Arrhythmia
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Ventricular Fibrillation
Cardiac disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Fanconi Syndrome
Congenital, familial and genetic disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Cataract
Eye disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Retinal Detachment
Eye disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Uveitis
Eye disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Vision Blurred
Eye disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Anal Fistula
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Colitis Ischaemic
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Colitis Ulcerative
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Diverticular Perforation
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Diverticulum Intestinal Haemorrhagic
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Duodenal Obstruction
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Hernial Eventration
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Inflammatory Bowel Disease
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Large Intestine Perforation
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Mallory-Weiss Syndrome
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0006 affected538 at risk
EG0016 affected536 at risk
EG0020 affected215 at risk
EG003
Neutropenic Colitis
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pancreatic Cyst
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0005 affected538 at risk
EG0014 affected536 at risk
EG0020 affected215 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0016 affected536 at risk
EG0020 affected215 at risk
EG003
Asthenia
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Chest Discomfort
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Chest Pain
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Chills
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Death
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0016 affected536 at risk
EG0021 affected215 at risk
EG003
Hernia
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Hyperthermia
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Inflammation
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Malaise
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Medical Device Site Joint Pain
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pain
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Pyrexia
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG00022 affected538 at risk
EG00115 affected536 at risk
EG0020 affected215 at risk
EG003
Sudden Death
General disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hepatocellular Injury
Hepatobiliary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Anaphylactic Shock
Immune system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Arthritis Bacterial
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Bacterial Pyelonephritis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Bacterial Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Bartholinitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0017 affected536 at risk
EG0020 affected215 at risk
EG003
Bronchopulmonary Aspergillosis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cellulitis Staphylococcal
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Chronic Sinusitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Clostridial Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Clostridium Colitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Clostridium Difficile Colitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Clostridium Difficile Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cytomegalovirus Gastroenteritis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Cytomegalovirus Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Cytomegalovirus Oesophagitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Dermo-Hypodermitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Device Related Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Ear Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Eczema Infected
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Encephalitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Endocarditis Staphylococcal
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Enterococcal Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Epstein-Barr Virus Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Erysipelas
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Escherichia Bacteraemia
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Escherichia Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Fungal Oesophagitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Gastroenteritis Salmonella
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hepatitis E
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0021 affected215 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Herpes Zoster Meningitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Infectious Colitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Infective Thrombosis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0014 affected536 at risk
EG0020 affected215 at risk
EG003
Intervertebral Discitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Intestinal Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Legionella Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Localised Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Lower Respiratory Tract Infection Viral
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Lung Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0015 affected536 at risk
EG0023 affected215 at risk
EG003
Meningitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Metapneumovirus Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Parotitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Peritonitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumococcal Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumocystis Jirovecii Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumocystis Jirovecii Pneumonia
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0004 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0009 affected538 at risk
EG00121 affected536 at risk
EG0022 affected215 at risk
EG003
Pneumonia Acinetobacter
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Escherichia
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Fungal
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Haemophilus
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Influenzal
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Legionella
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Parainfluenzae Viral
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Pneumococcal
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Pseudomonal
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Respiratory Syncytial Viral
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Viral
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pulmonary Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Respiratory Syncytial Virus Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Respiratory Tract Infection Viral
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Salmonella Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG00011 affected538 at risk
EG0017 affected536 at risk
EG0021 affected215 at risk
EG003
Septic Shock
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0014 affected536 at risk
EG0020 affected215 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Skin Bacterial Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Spinal Cord Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Staphylococcal Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Streptococcal Bacteraemia
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Streptococcal Endocarditis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Streptococcal Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Streptococcal Sepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Systemic Mycosis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Thrombophlebitis Septic
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Urosepsis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Varicella
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Varicella Zoster Virus Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Viral Diarrhoea
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Viral Rhinitis
Infections and infestations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Blood Stem Cell Harvest Failure
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Burns Second Degree
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Forearm Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Fractured Sacrum
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Jaw Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pelvic Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Perirenal Haematoma
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Post Procedural Complication
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Product Preparation Error
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0021 affected215 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0005 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Spinal Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0012 affected536 at risk
EG0021 affected215 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Thoracic Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0010 affected536 at risk
EG0022 affected215 at risk
EG003
Toxicity to Various Agents
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
General Physical Condition Abnormal
Investigations
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Hepatic Enzyme Abnormal
Investigations
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cell Death
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0014 affected536 at risk
EG0020 affected215 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Diabetic Metabolic Decompensation
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Fluid Overload
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Fluid Retention
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0021 affected215 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Tumour Lysis Syndrome
Metabolism and nutrition disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0009 affected538 at risk
EG0019 affected536 at risk
EG0020 affected215 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0004 affected538 at risk
EG0013 affected536 at risk
EG0021 affected215 at risk
EG003
Gouty Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Intervertebral Disc Compression
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0022 affected215 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0022 affected215 at risk
EG003
Osteolysis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Osteonecrosis of Jaw
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pathological Fracture
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Acute Myeloid Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Adenocarcinoma of Colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Anaplastic Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0012 affected536 at risk
EG0022 affected215 at risk
EG003
Bladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Bladder Cancer Recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Blastic Plasmacytoid Dendritic Cell Neoplasia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Bowen's Disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Cancer Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Gastrointestinal Tract Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Intraductal Proliferative Breast Lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Invasive Ductal Breast Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0021 affected215 at risk
EG003
Lip Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Lung Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Lung Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Myelodysplastic Syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Natural Killer-Cell Lymphoblastic Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Papillary Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Pituitary Tumour Benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Plasma Cell Myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Renal Oncocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Squamous Cell Carcinoma of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0012 affected536 at risk
EG0021 affected215 at risk
EG003
T-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Acute Motor-Sensory Axonal Neuropathy
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Amnestic Disorder
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Autonomic Neuropathy
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Cerebellar Haematoma
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Cerebral Haemorrhage
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cervicobrachial Syndrome
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Epidural Lipomatosis
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Hemiparaesthesia
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Peripheral Motor Neuropathy
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0012 affected536 at risk
EG0021 affected215 at risk
EG003
Peripheral Sensorimotor Neuropathy
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG00016 affected538 at risk
EG00111 affected536 at risk
EG0020 affected215 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0004 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Posterior Reversible Encephalopathy Syndrome
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Seizure
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0005 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Status Epilepticus
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Transient Global Amnesia
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Device Breakage
Product Issues
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Abnormal Behaviour
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Agitation
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Anxiety Disorder
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Delusional Disorder, Unspecified Type
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0004 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Major Depression
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Mental Disorder
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Chronic Kidney Disease
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Cystitis Haemorrhagic
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Myeloma Cast Nephropathy
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0021 affected215 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0003 affected538 at risk
EG0011 affected536 at risk
EG0021 affected215 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Renal Tubular Necrosis
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Urinary Bladder Haemorrhage
Renal and urinary disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Endometrial Hyperplasia
Reproductive system and breast disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Genital Prolapse
Reproductive system and breast disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Uterine Cervical Metaplasia
Reproductive system and breast disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Acute Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Acute Respiratory Distress Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0013 affected536 at risk
EG0021 affected215 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Bronchopneumopathy
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0013 affected536 at risk
EG0020 affected215 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0004 affected538 at risk
EG0012 affected536 at risk
EG0020 affected215 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0021 affected215 at risk
EG003
Eosinophilic Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Idiopathic Interstitial Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Interstitial Lung Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Lung Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0006 affected538 at risk
EG00110 affected536 at risk
EG0020 affected215 at risk
EG003
Pharyngeal Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0002 affected538 at risk
EG0015 affected536 at risk
EG0021 affected215 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG00020 affected538 at risk
EG0018 affected536 at risk
EG0020 affected215 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0000 affected538 at risk
EG0011 affected536 at risk
EG0020 affected215 at risk
EG003
Sinus Polyp
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Acute Generalised Exanthematous Pustulosis
Skin and subcutaneous tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA Version 21.0
Non-systematic Assessment
EG0001 affected538 at risk
EG0010 affected536 at risk
EG0020 affected215 at risk
EG003
Drug Reaction with Eosinophilia and Systemic Symptoms
OG00046.7(40.0 to NA)The upper limit of the Confidence Interval is not estimable due to insufficient number of participants with events.
OG001NA(NA to NA)The Median time to progression was not reached in this arm. Consequently, the lower and upper limit of the Confidence Interval is not available due to insufficient number of participants with events.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
<0.0001
Hazard Ratio (HR)
0.53
2-Sided
95
0.42
0.68
Superiority
Units
Counts
Participants
OG000542
OG001543
Title
Denominators
Categories
Title
Measurements
OG00052.8(47.5 to 58.7)
OG00183.7(70.2 to NA)The upper limit of the Confidence Interval is not estimable due to insufficient number of participants with events.