Phase I Trial of BI 836845 for Various Solid Cancer | NCT01403974 | Trialant
NCT01403974
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jul 25, 2025Actual
Enrollment
61Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
BI 836845
Countries
Taiwan
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01403974
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1280.1
Secondary IDs
Not provided
Brief Title
Phase I Trial of BI 836845 for Various Solid Cancer
Official Title
A Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Patients With Advanced Solid Cancers With Repeated Administrations in Patients Showing Clinical Benefit
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Jul 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
Jul 19, 2011Actual
Primary Completion Date
Jul 8, 2015Actual
Completion Date
Dec 23, 2015Actual
First Submitted Date
Jul 12, 2011
First Submission Date that Met QC Criteria
Jul 26, 2011
First Posted Date
Jul 27, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 14, 2025
Results First Submitted that Met QC Criteria
Jul 24, 2025
Results First Posted Date
Jul 25, 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
Jul 24, 2025
Last Update Posted Date
Jul 25, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new drug BI 836845 which blocks the insulin-like growth factor (IGF) pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients.
The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics).
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
61Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: BI 836845 10 mg
Experimental
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 20 mg
Experimental
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 40 mg
Experimental
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 60 mg
Experimental
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 90 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BI 836845
Drug
Intravenous infusion once every week
Part 1: BI 836845 10 mg
Part 1: BI 836845 1050 mg
Part 1: BI 836845 135 mg
Part 1: BI 836845 1400 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Maximum Tolerated Dose (MTD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase.
In the absence of MTD, the relevant biological dose (RBD) of BI 836845 during the first treatment course of the dose escalation phase was reported. The MTD was defined as the highest dose level of BI 836845 at which no more than 1 out of 6 patients experienced a drug related dose limiting toxicity (DLT) during the first course of treatment. Starting dose of 10 milligrams (mg) BI 836845, administered thrice every 3 weeks. Dose levels evaluated were: 10 mg, 20 mg, 40 mg, 60 mg, 90 mg, 135 mg, 200 mg, 300 mg, 450 mg, 600 mg, 800 mg, 1050 mg, 1400 mg and 1800 mg.
The BI 836845 dose which could achieve a plateau in total Insulin-like growth factor 1 (IGF-1) plasma concentrations was considered the RBD.
During the first course of treatment, up to 21 days
Part 1: Number of Patients With Dose Limiting Toxicities (DLTs) During the Maximum Tolerated Dose (MTD) Evaluation Period
Number of participants with DLTs occurring during the first treatment course of the dose escalation part. DLT was defined as drug-related adverse events meeting the criteria summarized below:
Common terminology criteria for adverse events (CTCAE) grade 4 neutropenia for ≥ 7 days (d)
Febrile neutropenia with single temperature of > 38.3°C/ ≥ 38°C more than 1 hour (h)
AST (Aspartate Amino Transferase)/ALT (Alanine Amino Transferase) > 5x normal
CTCAE grade 3/4 non-hematologic toxicity
CTCAE grade ≥2 infusion reaction
CTCAE grade ≥2 nausea and/or vomiting for ≥7 d
CTCAE grade ≥3 skin toxicity
CTCAE grade ≥3 hyperglycemia
Any electrolyte grade 3 AE
No recovery from non-DLT CTCAE grade >2
Sustained fatigue/asthenia grade 3 for longer than 96 h
Other event qualified as DLT by the investigator
During the first course of treatment, up to 21 days
Secondary Outcomes
Measure
Description
Time Frame
Objective Tumour Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Number of patients with the objective response (OR). Objective response was defined as best overall response of complete response (CR) or partial response (PR) (with no confirmation required) based on Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. CR was defined by the disappearance of all target lesions and PR was defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The best overall response was recorded since first administration of the trial medication and until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid cancer, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment.
Patients should have evaluable disease, or at least one measurable lesion according to RECIST criteria version 1.1.
Age 18 years or older.
Life expectancy of at least 3 months in the opinion of the investigator.
Written informed consent that is consistent with ICH-GCP guidelines and local legislation.
Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2.
Patients must have recovered from any previous surgery and have had no major surgery within the last 28 days prior to start of trial medication in the opinion of the investigator.
Cardiac left ventricular function with resting ejection fraction > 50% as determined by ECHO or MUGA.
Absolute neutrophil count = 1,500/µL.
Platelets =100,000/µL.
Total bilirubin = 1.5x institution ULN.
AST and ALT = 2.5x institution ULN (in case of hepatic primary cancer or known liver metastases: AST and ALT = 5x ULN).
Creatinine =1.5 x institution ULN.
Haemoglobin = 9g/dL.
Haemoglobin A1c less than 8% and fasting plasma glucose =160 mg/dL (=8.9 mmol/L).
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of trial participation. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of trial enrolment.
Child-Pugh score 5 or 6. (this criterion is limited to HCC patients in Part II only).
Patients eligible to undergo tumor biopsy should have normal coagulation parameters (INR and PTT within normal range). (this criterion is limited to patients in Part II only)
Exclusion criteria:
Active infectious disease considered by the investigator to be incompatible with the protocol.
Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
History of thrombosis (except tumor invading great vessel) within 1 year of study or if concurrent anticoagulation required, except low-dose warfarin (up to 1 mg/day).
Patients not recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, molecular targeted, or radiotherapies to at least CTCAE = Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least 4 weeks before starting trial medication, no history of cerebral oedema or bleeding in the past 4 weeks before starting trial medication and must be on a stable or reducing dose of dexamethasone. Anti-epileptic therapy will be allowed if the patient is stable on antiepileptic treatment for 4 weeks, or more, without adjustments before starting trial medication.
Patients who have been treated with any of the following within 4 weeks of starting trial medication: chemotherapy, immunotherapy, radiotherapy, molecular-targeted therapy, biological therapies (including trastuzumab), hormone therapy for breast cancer within 2 weeks of starting trial medication (excluding LHRH agonists in prostate cancer, or bisphosphonates), or treatment with other investigational drugs.
Use of any investigational drug within 4 weeks before start of trial medication or concomitantly with this trial.
Patients unable to comply with the protocol.
Active alcohol abuse or active drug abuse (at the discretion of the investigator).
Patients with unstable arrhythmias or unstable angina or severe obstructive pulmonary disease within the last year.
For patients entering Part II of the study, prior use of any IGF inhibitor.
Pregnancy or breast feeding.
Other malignancy requiring active therapy.
Patients with a history of diabetes mellitus.
For patients that are to undergo tumor biopsy, a history of a hereditary bleeding disorder or clinically relevant major bleeding event in the past 6 months as judged by the investigator (this criterion is limited to patients in Part II only)
de Bono J, Lin CC, Chen LT, Corral J, Michalarea V, Rihawi K, Ong M, Lee JH, Hsu CH, Yang JC, Shiah HS, Yen CJ, Anthoney A, Jove M, Buschke S, Fuertig R, Schmid U, Goeldner RG, Strelkowa N, Huang DC, Bogenrieder T, Twelves C, Cheng AL. Two first-in-human studies of xentuzumab, a humanised insulin-like growth factor (IGF)-neutralising antibody, in patients with advanced solid tumours. Br J Cancer. 2020 Apr;122(9):1324-1332. doi: 10.1038/s41416-020-0774-1. Epub 2020 Mar 12.
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/ms
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were to be entered to trial drug if any of the specific entry criteria was violated.
Recruitment Details
Part 1: dose escalation in patients with advanced solid tumours to determine maximum tolerated dose (MTD) or relevant biological dose (RBD); Part 2: expansion part at the RBD in patients with selected tumour types (Cohort 1- Ewing's sarcoma family of tumours; Cohort 2 - biopsiable solid tumours) in order to investigate safety and pharmacokinetics.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
FG014
Part 2: Ewing's Sarcoma Family of Tumours
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
FG015
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0088 subjects
FG0093 subjects
FG0104 subjects
FG0113 subjects
FG0123 subjects
FG0133 subjects
FG0141 subjects
FG01512 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Progressive disease according to RECIST
FG0003 subjects
FG0013 subjects
FG0022 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Maximum Tolerated Dose (MTD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase.
In the absence of MTD, the relevant biological dose (RBD) of BI 836845 during the first treatment course of the dose escalation phase was reported. The MTD was defined as the highest dose level of BI 836845 at which no more than 1 out of 6 patients experienced a drug related dose limiting toxicity (DLT) during the first course of treatment. Starting dose of 10 milligrams (mg) BI 836845, administered thrice every 3 weeks. Dose levels evaluated were: 10 mg, 20 mg, 40 mg, 60 mg, 90 mg, 135 mg, 200 mg, 300 mg, 450 mg, 600 mg, 800 mg, 1050 mg, 1400 mg and 1800 mg.
The BI 836845 dose which could achieve a plateau in total Insulin-like growth factor 1 (IGF-1) plasma concentrations was considered the RBD.
Treated set (TS) restricted to the part 1 (dose escalation) of the trial: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment in the dose escalation part of the trial.
Posted
Number
milligram (mg)
During the first course of treatment, up to 21 days
ID
Adverse Events Module
Frequency Threshold
5
Time Frame
First treatment administration until end of treatment plus residual effect period; Up to 74 weeks.
Description
Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C588089
xentuzumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Part 1 was conducted in a sequential manner and Part 2 was conducted in a parallel design.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 135 mg
Experimental
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 200 mg
Experimental
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
Drug: BI 836845
Part 1: BI 836845 300 mg
Experimental
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 450 mg
Experimental
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 600 mg
Experimental
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 800 mg
Experimental
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 1050 mg
Experimental
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 1400 mg
Experimental
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 1: BI 836845 1800 mg
Experimental
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study.
Drug: BI 836845
Part 2: Ewing's sarcoma family of tumours
Experimental
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.
Drug: BI 836845
Part 2: Biopsiable tumours
Experimental
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.
Drug: BI 836845
Part 1: BI 836845 1800 mg
Part 1: BI 836845 20 mg
Part 1: BI 836845 200 mg
Part 1: BI 836845 300 mg
Part 1: BI 836845 40 mg
Part 1: BI 836845 450 mg
Part 1: BI 836845 60 mg
Part 1: BI 836845 600 mg
Part 1: BI 836845 800 mg
Part 1: BI 836845 90 mg
Part 2: Biopsiable tumours
Part 2: Ewing's sarcoma family of tumours
Xentuzumab
First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.
Duration of Objective Response
Duration of objective response (days), defined as time from first objective response to the time to progression or death and was only calculated for patients with an objective response (with no confirmation required).
First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1
Number of patients with best overall response. Best overall response represented the best response (complete response - CR, partial response - PR, stable disease -SD, progressive disease - PD) a patient had during their time in the study from first administration of trial medication until the earliest date of progression, or the last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. CR was defined by the disappearance of all target lesions and PR was defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
First treatment administration until disease progression or last evaluable assessment in absence of progression; Up to 72 weeks
Disease Control
Number of patients with Disease control. Disease control was defined as best overall response of CR, PR or SD >24 week, with no confirmation required.
First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.
Part 2 - Biopsiable Tumours: Progression-free Survival (PFS)
PFS was evaluated only for cohort 2 (Biopsiable tumors) in expansion phase of the study. PFS was defined as the time from first treatment administration until tumour progression according to RECIST 1.1 or death from any cause, whichever occurred earlier. Median duration along with 95% confidence interval is based on Kaplan-Meier method.
First treatment administration until tumour progression or death. Up to 72 weeks
Maximum Measured Concentration of the BI 836845 in Plasma (Cmax)
Maximum measured concentration of the BI 836845 in plasma (Cmax). Geometric mean (gMean) and Geometric coefficient of variation (gCV) is presented for each course. As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2.
For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72*, 168, 169, 336 and 337 hours after infusion. * applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.
Up to 337 hours. Detailed timeframe is in the description.
Time to Maximum Measured Concentration BI 836845 in Plasma (Tmax)
Time to maximum measured concentration of the BI 836845 in plasma (tmax). As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2.
For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72*, 168, 169, 336 and 337 hours after infusion. * applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.
Up to 337 hours. Detailed timeframe is in the description.
Area Under the Plasma Concentration-time Curve of BI 836845 From Time 0 to 168 Hours (AUC 0-168)
Area under the plasma concentration-time curve from time 0 to 168 hours (AUC 0-168) of the BI 836845. As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2.
For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72*, 168, 169, 336 and 337 hours after infusion. * applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.
In the arm BI 836845 450 mg, data from 3 participants was available (15800, 20400 and 12700); as these 3 subjects represented less than 2/3 of the participants included in this course and this dose group, no descriptive statistics were presented in the Clinical Trial Report. The gMean and gCV values were calculated post hoc for ClinicalTrials.gov disclosure purpose only.
Up to 337 hours. Detailed timeframe is in the description.
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Number of patients with adverse events (AEs) according to the grading as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The intensity of AEs was defined based on:
Grade 1 - Mild AE; awareness of sign(s) or symptom(s) which is/are easily tolerated.
Grade 2 - Moderate AE; enough discomfort to cause interference with usual activity.
Grade 3 - Severe AE; incapacitating or causing inability to work or to perform usual activities.
Grade 4 - Life-threatening or disabling AE.
Grade 5 - Death related to AE.
First treatment administration until end of treatment plus residual effect period; Up to 74 weeks
Tainan
70403
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
3 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0088 subjects
FG0093 subjects
FG0104 subjects
FG0113 subjects
FG0123 subjects
FG0133 subjects
FG0141 subjects
FG01512 subjects
3 subjects
FG0043 subjects
FG0052 subjects
FG0063 subjects
FG0072 subjects
FG0086 subjects
FG0092 subjects
FG0103 subjects
FG0112 subjects
FG0122 subjects
FG0133 subjects
FG0141 subjects
FG0158 subjects
Dose limiting toxicity (DLT)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Refused to continue study medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0154 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Other than specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
BG014
Part 2: Ewing's Sarcoma Family of Tumours
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
BG015
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
BG016
Total
Total of all reporting groups
3
BG0013
BG0023
BG0033
BG0043
BG0053
BG0063
BG0073
BG0088
BG0093
BG0104
BG0113
BG0123
BG0133
BG0141
BG01512
BG01661
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
Between 18 and 65 years
BG0002
BG0013
BG0022
BG0033
BG004
>=65 years
BG0001
BG0010
BG0021
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG0021
BG0033
BG0041
BG0052
BG0061
BG0070
BG0082
BG0091
BG0100
BG0111
BG0120
BG0130
BG0140
BG0159
BG01623
Male
BG0002
BG0012
BG0022
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
Asian
BG0003
BG0013
BG0023
BG0033
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0000
BG0010
BG0020
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Indian subcontinent Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
Southeast Asian
BG0000
BG0010
BG0020
BG0030
BG004
Japanese
BG0000
BG0010
BG0020
BG0030
BG004
Korean
BG0000
BG0010
BG0020
BG0030
BG004
Taiwanese or Chinese
BG0003
BG0013
BG0023
BG0033
BG004
Asian - other
BG0000
BG0010
BG0020
BG0030
BG004
Title
Description
OG000
Part 1: BI 836845
BI 836845 administered intravenously once every three weeks in patients with advanced solid tumours during dose escalation part of the study
Units
Counts
Participants
OG00048
Title
Denominators
Categories
Title
Measurements
OG0001000
Primary
Part 1: Number of Patients With Dose Limiting Toxicities (DLTs) During the Maximum Tolerated Dose (MTD) Evaluation Period
Number of participants with DLTs occurring during the first treatment course of the dose escalation part. DLT was defined as drug-related adverse events meeting the criteria summarized below:
Common terminology criteria for adverse events (CTCAE) grade 4 neutropenia for ≥ 7 days (d)
Febrile neutropenia with single temperature of > 38.3°C/ ≥ 38°C more than 1 hour (h)
AST (Aspartate Amino Transferase)/ALT (Alanine Amino Transferase) > 5x normal
CTCAE grade 3/4 non-hematologic toxicity
CTCAE grade ≥2 infusion reaction
CTCAE grade ≥2 nausea and/or vomiting for ≥7 d
CTCAE grade ≥3 skin toxicity
CTCAE grade ≥3 hyperglycemia
Any electrolyte grade 3 AE
No recovery from non-DLT CTCAE grade >2
Sustained fatigue/asthenia grade 3 for longer than 96 h
Other event qualified as DLT by the investigator
TS restricted to the part 1 (dose escalation) of the trial: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment in the dose escalation part of the trial. Three patients (two patients at the 450 mg and one patient at 800 mg) were replaced thus not included in the analysis of primary endpoint.
Posted
Count of Participants
Participants
During the first course of treatment, up to 21 days
ID
Title
Description
OG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Objective Tumour Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Number of patients with the objective response (OR). Objective response was defined as best overall response of complete response (CR) or partial response (PR) (with no confirmation required) based on Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. CR was defined by the disappearance of all target lesions and PR was defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The best overall response was recorded since first administration of the trial medication and until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy.
Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Posted
Count of Participants
Participants
First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.
ID
Title
Description
OG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG014
Part 2: Ewing's Sarcoma Family of Tumours
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
OG015
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Duration of Objective Response
Duration of objective response (days), defined as time from first objective response to the time to progression or death and was only calculated for patients with an objective response (with no confirmation required).
Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. Only two subjects experienced event or were eligible for censoring.
Posted
Median
95% Confidence Interval
days
First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.
ID
Title
Description
OG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG014
Part 2: Ewing's Sarcoma Family of Tumours
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
OG015
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG010145(NA to NA)Only one subject reported OR in this dose group, hence actual duration is presented without confidence interval.
OG011213(NA to NA)Only one subject reported OR in this dose group, hence actual duration is presented without confidence interval.
Secondary
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1
Number of patients with best overall response. Best overall response represented the best response (complete response - CR, partial response - PR, stable disease -SD, progressive disease - PD) a patient had during their time in the study from first administration of trial medication until the earliest date of progression, or the last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. CR was defined by the disappearance of all target lesions and PR was defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Posted
Count of Participants
Participants
First treatment administration until disease progression or last evaluable assessment in absence of progression; Up to 72 weeks
ID
Title
Description
OG000
Part1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG014
Part 2: Ewing's Sarcoma Family of Tumours
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
OG015
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Disease Control
Number of patients with Disease control. Disease control was defined as best overall response of CR, PR or SD >24 week, with no confirmation required.
Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Posted
Count of Participants
Participants
First treatment administration until the earliest of disease progression, death, last adequate tumor assessment or the start of subsequent anti-cancer therapy. Up to 72 weeks.
ID
Title
Description
OG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG014
Part 2: Ewing's Sarcoma Family of Tumours
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
OG015
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0020
OG003
Secondary
Part 2 - Biopsiable Tumours: Progression-free Survival (PFS)
PFS was evaluated only for cohort 2 (Biopsiable tumors) in expansion phase of the study. PFS was defined as the time from first treatment administration until tumour progression according to RECIST 1.1 or death from any cause, whichever occurred earlier. Median duration along with 95% confidence interval is based on Kaplan-Meier method.
TS restricted to the part 2 - biopsiable tumours cohort (dose expansion) of the trial: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment in the biopsiable tumours cohort of the dose escalation part of the trial.
Posted
Median
95% Confidence Interval
days
First treatment administration until tumour progression or death. Up to 72 weeks
ID
Title
Description
OG000
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG000118.0(18.0 to 504.0)
Secondary
Maximum Measured Concentration of the BI 836845 in Plasma (Cmax)
Maximum measured concentration of the BI 836845 in plasma (Cmax). Geometric mean (gMean) and Geometric coefficient of variation (gCV) is presented for each course. As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2.
For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72*, 168, 169, 336 and 337 hours after infusion. * applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.
Pharmacokinetic (PK) set: All patients in the treated set who were documented to have received at least one dose of BI 836845 and who had at least one valid PK parameter concentration available. Participants with no available blood samples were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (µg/ml)
Up to 337 hours. Detailed timeframe is in the description.
ID
Title
Description
OG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG014
Part 2: Expansion Cohort
Patients receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Course 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Time to Maximum Measured Concentration BI 836845 in Plasma (Tmax)
Time to maximum measured concentration of the BI 836845 in plasma (tmax). As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2.
For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72*, 168, 169, 336 and 337 hours after infusion. * applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.
Pharmacokinetic (PK) set: All patients in the treated set who were documented to have received at least one dose of BI 836845 and who had at least one valid PK parameter concentration available. Participants with no available blood samples were excluded from the analysis.
Posted
Median
Full Range
hours
Up to 337 hours. Detailed timeframe is in the description.
ID
Title
Description
OG000
BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG014
Expansion Cohort
Patients receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Course 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-time Curve of BI 836845 From Time 0 to 168 Hours (AUC 0-168)
Area under the plasma concentration-time curve from time 0 to 168 hours (AUC 0-168) of the BI 836845. As defined in the CTP, PK data is presented by BI 836845 dose level and was not collected for Course 4 part 2.
For Course 1 of part 1 and part 2, Course 2 part 1 and part 2, Course 3 part 2, Course 4 part 1 the following timeframe applies : At 0.083 hour before and 0.5, 1, 2, 4, 7, 24, 72*, 168, 169, 336 and 337 hours after infusion. * applies only to part 1 administration courses. In Course 3 of part 1 the following timeframe applies: At 0.083 hour before and 0.5, 1, 168, 169, 336 and 337 hours after infusion.
In the arm BI 836845 450 mg, data from 3 participants was available (15800, 20400 and 12700); as these 3 subjects represented less than 2/3 of the participants included in this course and this dose group, no descriptive statistics were presented in the Clinical Trial Report. The gMean and gCV values were calculated post hoc for ClinicalTrials.gov disclosure purpose only.
Pharmacokinetic (PK) set: All patients in the treated set who were documented to have received at least one dose of BI 836845 and who had at least one valid PK parameter concentration available. Participants with no available blood samples were excluded from the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram hour per milliliter (µg*h/mL)
Up to 337 hours. Detailed timeframe is in the description.
ID
Title
Description
OG000
BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG014
Expansion Cohort
Patients receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Course 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG003
Secondary
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Number of patients with adverse events (AEs) according to the grading as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The intensity of AEs was defined based on:
Grade 1 - Mild AE; awareness of sign(s) or symptom(s) which is/are easily tolerated.
Grade 2 - Moderate AE; enough discomfort to cause interference with usual activity.
Grade 3 - Severe AE; incapacitating or causing inability to work or to perform usual activities.
Grade 4 - Life-threatening or disabling AE.
Grade 5 - Death related to AE.
Treated set (TS): All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment.
Posted
Count of Participants
Participants
First treatment administration until end of treatment plus residual effect period; Up to 74 weeks
ID
Title
Description
OG000
Part 1: BI 836845 10 mg
Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
OG014
Part 2: Ewing's Sarcoma Family of Tumours
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
OG015
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0000
OG0011
OG0020
OG003
1
3
3
3
EG001
Part 1: BI 836845 20 mg
Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
0
3
2
3
EG002
Part 1: BI 836845 40 mg
Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
2
3
3
3
EG003
Part 1: BI 836845 60 mg
Patients received 60 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
1
3
3
3
EG004
Part 1: BI 836845 90 mg
Patients received 90 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
1
3
3
3
EG005
Part 1: BI 836845 135 mg
Patients received 135 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
1
3
3
3
EG006
Part 1: BI 836845 200 mg
Patients received 200 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
1
3
3
3
EG007
Part 1: BI 836845 300 mg
Patients received 300 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
1
3
3
3
EG008
Part 1: BI 836845 450 mg
Patients received 450 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
3
8
8
8
EG009
Part 1: BI 836845 600 mg
Patients received 600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
1
3
3
3
EG010
Part 1: BI 836845 800 mg
Patients received 800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
2
4
3
4
EG011
Part 1: BI 836845 1050 mg
Patients received 1050 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
0
3
3
3
EG012
Part 1: BI 836845 1400 mg
Patients received 1400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
1
3
2
3
EG013
Part 1: BI 836845 1800 mg
Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1, 8 and 15 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study
2
3
3
3
EG014
Part 2: Ewing's Sarcoma Family of Tumours
Patients with Ewing's sarcoma family of tumours (ESFT) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
0
1
1
1
EG015
Part 2: Biopsiable Tumours
Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study
4
12
11
12
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Device related infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pneumonia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Diabetes insipidus
Endocrine disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Gastrointestinal mucosal disorder
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Ileus
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Bacteraemia
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Cellulitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Liver abscess
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Peritonitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Septic shock
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Weight decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Cauda equina syndrome
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Cerebral ischaemia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Syncope
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Superior vena cava syndrome
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0091 affected3 at risk
EG0102 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0003 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0092 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0152 affected12 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0152 affected12 at risk
Constipation
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0131 affected3 at risk
EG0141 affected1 at risk
EG0154 affected12 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0081 affected8 at risk
EG0091 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0071 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0153 affected12 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0141 affected1 at risk
EG0154 affected12 at risk
Chest discomfort
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Chest pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0082 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0071 affected3 at risk
EG0081 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Malaise
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0141 affected1 at risk
EG0150 affected12 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Catheter site infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Oral candidiasis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0152 affected12 at risk
Urinary tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Alanine aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Weight decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0003 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0062 affected3 at risk
EG0071 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0153 affected12 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0152 affected12 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0152 affected12 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0112 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0141 affected1 at risk
EG0152 affected12 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0092 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Neuralgia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Tremor
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Anxiety
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Insomnia
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0141 affected1 at risk
EG0150 affected12 at risk
Haematuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Nocturia
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0084 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0082 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Hypertension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Hypotension
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Atrial flutter
Cardiac disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Hydrocele
Congenital, familial and genetic disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Eye pruritus
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Miosis
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Neurotrophic keratopathy
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Ascites
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Cheilitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Chronic gastritis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Epigastric discomfort
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Gastric ulcer
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Gastritis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Melaena
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Oral pain
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Peptic ulcer
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Tongue ulceration
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Asthenia
General disorders
MedDRA 19.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Local swelling
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Mucosal inflammation
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Non-cardiac chest pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Oedema
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Oedema peripheral
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0153 affected12 at risk
Pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Hepatomegaly
Hepatobiliary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Conjunctivitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Epididymitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pulpitis dental
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Wound
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Blood bilirubin increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Blood cholesterol increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0082 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Blood creatinine increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Lymphocyte count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Neutrophil count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Platelet count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0042 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pulmonary physical examination abnormal
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
White blood cell count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Cachexia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0082 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0141 affected1 at risk
EG0150 affected12 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Chondritis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Myofascial pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Neoplasm of orbit
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Facial paresis
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Paraesthesia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0082 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Delirium
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Dysuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Hydronephrosis
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Neurogenic bladder
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Proteinuria
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Urinary retention
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Oligomenorrhoea
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pelvic pain
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0152 affected12 at risk
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0082 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0131 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0121 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0081 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0151 affected12 at risk
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Flushing
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
Lymphoedema
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected8 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected3 at risk
EG0120 affected3 at risk
EG0130 affected3 at risk
EG0140 affected1 at risk
EG0150 affected12 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
2
BG0052
BG0063
BG0073
BG0086
BG0093
BG0104
BG0113
BG0122
BG0133
BG0141
BG0158
BG01650
1
BG0051
BG0060
BG0070
BG0082
BG0090
BG0100
BG0110
BG0121
BG0130
BG0140
BG0154
BG01611
2
BG0051
BG0062
BG0073
BG0086
BG0092
BG0104
BG0112
BG0123
BG0133
BG0141
BG0153
BG01638
3
BG0053
BG0063
BG0073
BG0088
BG0093
BG0104
BG0113
BG0123
BG0133
BG0141
BG01512
BG01661
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
3
BG0053
BG0063
BG0073
BG0088
BG0093
BG0104
BG0113
BG0123
BG0133
BG0141
BG01512
BG01661
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0104
OG0113
OG0123
OG0133
0
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
OG0100
OG0110
OG0120
OG0130
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0104
OG0113
OG0123
OG0133
OG0141
OG01512
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0111
OG0120
OG0130
OG0140
OG0150
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0111
OG0120
OG0130
OG0140
OG0150
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0104
OG0113
OG0123
OG0133
OG0141
OG01512
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
PR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0111
OG0120
OG0130
OG0140
OG0150
SD
Title
Measurements
OG0002
OG0011
OG0022
OG0032
OG0042
OG0050
OG0062
OG0071
OG0083
OG0093
OG0102
OG0110
OG0121
OG0131
OG0141
OG0157
SD≥24 weeks
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
OG0120
OG0130
OG0140
OG0153
PD
Title
Measurements
OG0001
OG0012
OG0020
OG0031
OG0041
OG0052
OG0061
OG0072
OG0083
OG0090
OG0101
OG0112
OG0122
OG0132
OG0140
OG0153
Not evaluable
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0051
OG0060
OG0070
OG0082
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0152
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0104
OG0113
OG0123
OG0133
OG0141
OG01512
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0101
OG0111
OG0120
OG0130
OG0140
OG0153
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0104
OG0113
OG0123
OG0133
OG01413
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0088
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG01413
Title
Measurements
OG0002.87± 23.8
OG0016.53± 14.9
OG00213.8± 26.6
OG00322.2± 3.78
OG00428.2± 28.7
OG00536.6± 20.6
OG00670.8± 26.7
OG00781.9± 42.2
OG008151± 16.7
OG009199± 10.8
OG010200± 38.1
OG011270± 38.9
OG012415± 13.0
OG013503± 13.4
OG014386± 30.7
Course 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0085
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0149
Title
Measurements
OG0003.34± 31.9
OG0017.92± 24.8
OG00222.4± 23.9
OG003
Course 3
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0092
ParticipantsOG0102
ParticipantsOG0112
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0148
Title
Measurements
OG000NA± NANot evaluable due to sparse sampling.
OG001NA± NANot evaluable due to sparse sampling.
OG002NA± NANot evaluable due to sparse sampling.
OG003
Course 4
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0111
ParticipantsOG0121
ParticipantsOG0131
ParticipantsOG0140
Title
Measurements
OG0003.96± 53.9
OG0015.27± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG00218.8± 1.88
OG003
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0104
OG0113
OG0123
OG0133
OG01413
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0088
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG01413
Title
Measurements
OG0002.10(1.15 to 4.00)
OG0012.02(1.75 to 6.38)
OG0022.03(2.00 to 2.03)
OG0031.13(1.03 to 1.92)
OG0042.00(1.80 to 7.00)
OG0051.05(1.03 to 1.92)
OG0062.00(2.00 to 3.77)
OG0072.25(2.07 to 2.28)
OG0081.18(1.02 to 7.00)
OG0092.00(1.92 to 2.25)
OG0101.25(1.07 to 2.00)
OG0111.17(1.02 to 4.02)
OG0122.00(1.00 to 2.00)
OG0132.00(1.00 to 2.00)
OG0144.00(1.00 to 7.00)
Course 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0085
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0133
ParticipantsOG0149
Title
Measurements
OG0000.967(0.967 to 2.03)
OG0017.00(0.967 to 24.1)
OG0021.50(1.00 to 2.00)
OG003
Course 3
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0092
ParticipantsOG0102
ParticipantsOG0112
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0148
Title
Measurements
OG000NA(NA to NA)Not evaluable due to sparse sampling.
OG001NA(NA to NA)Not evaluable due to sparse sampling.
OG002NA(NA to NA)Not evaluable due to sparse sampling.
OG003
Course 4
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0111
ParticipantsOG0121
ParticipantsOG0131
ParticipantsOG0140
Title
Measurements
OG0003.33(1.75 to 4.90)
OG0012.23(NA to NA)Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.
OG0021.54(1.08 to 2.00)
OG003
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0104
OG0113
OG0123
OG0133
OG01413
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0087
ParticipantsOG0092
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0121
ParticipantsOG0131
ParticipantsOG01410
Title
Measurements
OG000249± 37.2
OG001390± 32.9
OG002752± 66.3
OG0031300± 42.5
OG0042250± 16.7
OG0053050± 17.7
OG0065950± 26.9
OG0075680± 23.1
OG00810600± 12.6
OG00915600± 7.09
OG01014500± 45.6
OG01131100± 64.9
OG01231800± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG01336200± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG01432200± 27.4
Course 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0092
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG0123
ParticipantsOG0132
ParticipantsOG0149
Title
Measurements
OG000265± 49.6
OG001627± 41.8
OG0021950± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG003
Course 3
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0092
ParticipantsOG0102
ParticipantsOG0112
ParticipantsOG0122
ParticipantsOG0132
ParticipantsOG0147
Title
Measurements
OG000NA± NANot evaluable due to sparse sampling.
OG001NA± NANot evaluable due to sparse sampling.
OG002NA± NANot evaluable due to sparse sampling.
OG003
Course 4
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0111
ParticipantsOG0121
ParticipantsOG0131
ParticipantsOG0140
Title
Measurements
OG000309± 132
OG001337± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG0021780± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG003
3
OG0043
OG0053
OG0063
OG0073
OG0088
OG0093
OG0104
OG0113
OG0123
OG0133
OG0141
OG01512
0
OG0041
OG0052
OG0060
OG0071
OG0082
OG0090
OG0100
OG0111
OG0121
OG0130
OG0140
OG0151
Grade 2
Title
Measurements
OG0002
OG0011
OG0021
OG0031
OG0041
OG0051
OG0061
OG0071
OG0084
OG0092
OG0102
OG0111
OG0120
OG0132
OG0141
OG0156
Grade 3
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0041
OG0050
OG0062
OG0070
OG0082
OG0091
OG0101
OG0111
OG0120
OG0130
OG0140
OG0153
Grade 4
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0101
OG0110
OG0121
OG0130
OG0140
OG0151
Grade 5
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0131
OG0140
OG0150
26.9
± 17.1
OG00436.6± 19.4
OG00555.2± 29.8
OG00699.2± 28.5
OG007100± 21.8
OG008193± 18.0
OG009285± 11.7
OG010282± 40.3
OG011393± 39.1
OG012559± 6.46
OG013732± 5.57
OG014607± 10.4
NA
± NA
Not evaluable due to sparse sampling.
OG004NA± NANot evaluable due to sparse sampling.
OG005NA± NANot evaluable due to sparse sampling.
OG006NA± NANot evaluable due to sparse sampling.
OG007NA± NANot evaluable due to sparse sampling.
OG008NA± NANot evaluable due to sparse sampling.
OG009NA± NANot evaluable due to sparse sampling.
OG010NA± NANot evaluable due to sparse sampling.
OG011NA± NANot evaluable due to sparse sampling.
OG012NA± NANot evaluable due to sparse sampling.
OG013NA± NANot evaluable due to sparse sampling.
OG014616± 24.8
28.5
± NA
Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG00439.6± 15.2
OG00686.8± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG008201± 10.9
OG009279± 28.6
OG010253± 36.3
OG011615± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG012612± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG013739± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
2.00
(0.983 to 2.00)
OG0042.15(1.00 to 4.00)
OG0052.89(1.03 to 4.75)
OG0062.97(2.00 to 7.00)
OG0071.45(1.05 to 2.02)
OG0081.12(1.05 to 2.02)
OG0092.07(1.12 to 5.95)
OG0101.83(1.40 to 2.00)
OG0114.00(3.95 to 4.00)
OG0121.00(1.00 to 2.00)
OG0132.00(1.00 to 4.00)
OG0142.00(1.00 to 24.0)
NA
(NA to NA)
Not evaluable due to sparse sampling.
OG004NA(NA to NA)Not evaluable due to sparse sampling.
OG005NA(NA to NA)Not evaluable due to sparse sampling.
OG006NA(NA to NA)Not evaluable due to sparse sampling.
OG007NA(NA to NA)Not evaluable due to sparse sampling.
OG008NA(NA to NA)Not evaluable due to sparse sampling.
OG009NA(NA to NA)Not evaluable due to sparse sampling.
OG010NA(NA to NA)Not evaluable due to sparse sampling.
OG011NA(NA to NA)Not evaluable due to sparse sampling.
OG012NA(NA to NA)Not evaluable due to sparse sampling.
OG013NA(NA to NA)Not evaluable due to sparse sampling.
OG0141.50(0.983 to 7.00)
1.02
(NA to NA)
Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.
OG0043.09(2.18 to 4.00)
OG0061.22(NA to NA)Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.
OG0082.00(1.63 to 7.00)
OG0092.00(1.17 to 3.97)
OG0101.00(1.00 to 1.00)
OG0114.00(NA to NA)Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.
OG0122.00(NA to NA)Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.
OG0132.00(NA to NA)Only one evaluable subject available for this course in this dose group. Provided Median is actual value, range could not be calculated.
1790
± NA
Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG0043390± 27.7
OG0055150± 52.2
OG0069490± 11.1
OG0079480± 3.39
OG00815997± 24.1
OG00921400± 13.0
OG01022000± 46.3
OG01138600± 34.0
OG01248300± 21.7
OG01367600± 9.57
OG01455500± 20.4
NA
± NA
Not evaluable due to sparse sampling.
OG004NA± NANot evaluable due to sparse sampling.
OG005NA± NANot evaluable due to sparse sampling.
OG006NA± NANot evaluable due to sparse sampling.
OG007NA± NANot evaluable due to sparse sampling.
OG008NA± NANot evaluable due to sparse sampling.
OG009NA± NANot evaluable due to sparse sampling.
OG010NA± NANot evaluable due to sparse sampling.
OG011NA± NANot evaluable due to sparse sampling.
OG012NA± NANot evaluable due to sparse sampling.
OG013NA± NANot evaluable due to sparse sampling.
OG01453700± 25.4
4010
± NA
Only one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG0043620± 3.91
OG00610300± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG00814300± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG00917900± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG01019000± 78.8
OG01156600± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG01252400± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.
OG01367400± NAOnly one evaluable subject available for this course in this dose group. Provided gMean is actual value, gCV could not be calculated.