Study of the JAK Inhibitor Ruxolitinib Administered Orall... | NCT01317875 | Trialant
NCT01317875
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Aug 22, 2025Actual
Enrollment
69Actual
Phase
Phase 1
Conditions
Myelofibrosis
Interventions
Ruxolitinib
Countries
United States
Austria
China
France
Germany
Italy
Netherlands
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01317875
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CINC424A2201
Secondary IDs
ID
Type
Description
Link
2010-023055-29
EudraCT Number
Brief Title
Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)
Official Title
A Phase Ib, Open-label, Dose-finding Study of the JAK Inhibitor INC424 Tablets Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-polycythemia Veramyelofibrosis (PPV-MF) or Post-essentialthrombocythemia-myelofibrosis (PET-MF) and Baseline Platelet Counts ≥50 x109/L and <100 x109/L (EXPAND)
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Aug 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
YesNCT03147742Approved for marketing
Start Date
Mar 31, 2011Actual
Primary Completion Date
Dec 31, 2019Actual
Completion Date
Dec 31, 2019Actual
First Submitted Date
Mar 14, 2011
First Submission Date that Met QC Criteria
Mar 16, 2011
First Posted Date
Mar 17, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 26, 2020
Results First Submitted that Met QC Criteria
Jan 10, 2022
Results First Posted Date
Mar 9, 2022Actual
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
Aug 20, 2025
Last Update Posted Date
Aug 22, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Name
Class
Novartis
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts < 100 x 10 ^9/L
Detailed Description
Not provided
Conditions Module
Conditions
Myelofibrosis
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
69Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stratum -1
Experimental
Participants with baseline Platelet counts of 75-99 x10^9/L
Drug: Ruxolitinib
Stratum -2
Experimental
Participants with baseline Platelet counts of 50-74 x10^9/L
Drug: Ruxolitinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ruxolitinib
Drug
Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg twice a day (BID)
Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities
DLT was defined as the occurrence of any of the following treatment-related toxicities, occurring through Day 28: Any grade ≥ 2 hemorrhagic event ; Any grade thrombocytopenia requiring PLT transfusion; PLT count < 25x109/L*; Grade 4 neutropenia (absolute neutrophil count < 0.5x109/L)*; Grade ≥ 3 febrile neutropenia*; Grade ≥ 2 total serum bilirubin with coincident direct bilirubin ≥ 0.5 mg/dL; Grade 3 non-hematologic toxicity for ≥ 7 consecutive days; Grade 4 non-hematologic toxicity. In the dose escalation stage in the core study period, the starting does in both strata was 5mg bid. Successive cohorts of newly enrolled patients received increasing doses of ruxolitinib until the Maximum Safe Starting Dose (MSSD) was determined. Initially, only patients with PLT counts 75-99 x10^9/L (stratum 1) were allowed to be enrolled. Once safety was established in stratum 1 at the first 2 dose cohorts, eligible population was further expanded to patients with PLT counts 50-74 x10^9/L (stratum 2).
28 days
Secondary Outcomes
Measure
Description
Time Frame
Number of Treatment Emergent Adverse Events (TEAE's)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
approximately 4 years
Number of Subjects Achieving ≥ 50% Reduction in Palpable Spleen Length
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Require treatment for MF and classified at least as intermediate risk level 1 defined by the International Working Group.
Platelet count < 100x10 ^9/L at screening or at Study Day 1.
Exclusion Criteria:
Received platelet transfusion within 14 days prior to Screening evaluations.
Guglielmelli P, Kiladjian JJ, Vannucchi AM, Duan M, Meng H, Pan L, He G, Verstovsek S, Boyer F, Barraco F, Niederwieser D, Pungolino E, Liberati AM, Harrison C, Roussou P, Wroclawska M, Karumanchi D, Sinclair K, Te Boekhorst PAW, Gisslinger H. Efficacy and safety of ruxolitinib in patients with myelofibrosis and low platelet count (50 x 109/L to <100 x 109/L) at baseline: the final analysis of EXPAND. Ther Adv Hematol. 2022 Sep 10;13:20406207221118429. doi: 10.1177/20406207221118429. eCollection 2022.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 69 participants enrolled in the study with 44 in Stratum 1 (cohorts 1,2,3,4,5) and 25 in Stratum 2 (Cohorts 1,2,3).
Recruitment Details
The study was conducted from 03-Mar-2011 to 31-Dec-2019 globally. Participants with MF and baseline PLT of 75 to < 100 × 109/L are enrolled in Stratum 1;and 50 to < 75 × 109/L are enrolled in Stratum 2.. The study has a core period (up to week 24) consisting of 2 phases (dose escalation and safety expansion) followed by an extension period (up to 3 years). Participants received increasing doses of ruxolitinib until the Maximum Safe Starting Dose (MSSD) was determined
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stratum 1 : Cohort 1
Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10^9/L
FG001
Stratum 1 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10^9/L
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 28, 2015
Dec 26, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Ireland
South Korea
Turkey (Türkiye)
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
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
Stratum -1
Stratum -2
INCB018424
Participants achieving ≥ 50% reduction in palpable spleen length relative to study day 1 by treatment and stratum
24 weeks
Change in Spleen Length as Measure by Palpation Over Time
Defined as measurement of change in spleen length by palpation from baseline
To define the PK and Tissue Necrosis Factor Receptor 2 relationship using PK Quartiles (AUC 0-12, ng*h/mL)
24 weeks
AUC 0-Inf
Area Under the Serum Concentration Versus Time Curve，Time 0 to Infinity
0.25 to 0.75, 1 to 3, and 4 to 12 hours postdose on Day 1 and predose, 0.25 to 0.75 hours, and 1 to 3 hours postdose on Day 15, with a random sample on Days 29 and 57
Baltimore
Maryland
21229
United States
Houston
Texas
77030
United States
Vienna
Austria
Nanjing
Jiangsu
China
Chengdu
Sichuan
China
Hangzhou
Zhejiang
China
Beijing
China
Angers
France
Paris
France
Pierre-Bénite
France
Leipzig
Germany
Florence
Italy
Milan
Italy
Terni
Italy
Rotterdam
Netherlands
Belfast
United Kingdom
London
United Kingdom
FG002
Stratum 1 : Cohort 3
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
FG003
Stratum 1 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in Participants with baseline Platelet counts of 75-99 x10^9/L
FG004
Stratum 1 : Cohort 5
Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
FG005
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10^9/L
FG006
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in participants with baseline Platelet counts of 50-74 x10^9/L
FG007
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
FG008
Stratum 2 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10^9/L
FG009
Stratum 2 : Cohort 5
Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
FG0005 subjects
FG0013 subjects
FG00220 subjects
FG0034 subjects
FG00412 subjects
FG0053 subjects
FG0064 subjects
FG00718 subjects
FG0080 subjectsNo participants enrolled in Stratum 2 : Cohort 4
FG0090 subjectsNo participants enrolled in Stratum 2 : Cohort 5
COMPLETED
FG0002 subjects
FG0011 subjects
FG00211 subjects
FG0032 subjects
FG0043 subjects
FG0051 subjects
FG0062 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0029 subjects
FG0032 subjects
FG0049 subjects
FG0052 subjects
FG0062 subjects
FG00715 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Noncompliance with study drug
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Progressive Disease
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Adverse Event
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Full Analysis Set
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stratum 1 : Cohort 1
Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10^9/L
BG001
Stratum 1 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10^9/L
BG002
Stratum 1 : Cohort 3
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
BG003
Stratum 1 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10^9/L
BG004
Stratum 1 : Cohort 5
Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
BG005
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10^9/L
BG006
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM) in participants with baseline Platelet counts of 50-74 x10^9/L
BG007
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
BG008
Stratum 2 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10^9/L
BG009
Stratum 2 : Cohort 5
Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0013
BG00220
BG0034
BG00412
BG0053
BG0064
BG00718
BG0080
BG0090
BG01069
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00063.00± 7.78
BG00154.00± 4.00
BG00263.0± 14.71
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0012
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
White
BG0005
BG0012
BG002
ECOG Performance Status
ECOG performance status has 3 Grades:
0 - Asymptomatic (fully active, able to carry on all pre-disease activities without restriction)
- Symptomatic but completely ambulatory (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
- Symptomatic, < 50% in bed during the day (ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0
BG0001
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities
DLT was defined as the occurrence of any of the following treatment-related toxicities, occurring through Day 28: Any grade ≥ 2 hemorrhagic event ; Any grade thrombocytopenia requiring PLT transfusion; PLT count < 25x109/L*; Grade 4 neutropenia (absolute neutrophil count < 0.5x109/L)*; Grade ≥ 3 febrile neutropenia*; Grade ≥ 2 total serum bilirubin with coincident direct bilirubin ≥ 0.5 mg/dL; Grade 3 non-hematologic toxicity for ≥ 7 consecutive days; Grade 4 non-hematologic toxicity. In the dose escalation stage in the core study period, the starting does in both strata was 5mg bid. Successive cohorts of newly enrolled patients received increasing doses of ruxolitinib until the Maximum Safe Starting Dose (MSSD) was determined. Initially, only patients with PLT counts 75-99 x10^9/L (stratum 1) were allowed to be enrolled. Once safety was established in stratum 1 at the first 2 dose cohorts, eligible population was further expanded to patients with PLT counts 50-74 x10^9/L (stratum 2).
Dose Determining Set. Dose was not escalated to enroll participants in Stratum-2 : Cohorts 4 and 5.
Posted
Count of Participants
Participants
28 days
ID
Title
Description
OG000
Stratum 1 : Cohort 1
Ruxolitinib was administered at 5 mg bid
OG001
Stratum 1 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
OG002
Stratum 1 : Cohort 3
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 10 mg q.PM
OG003
Stratum 1 : Cohort 4
Ruxolitinib was administered at a starting dose of 10 mg q.AM + 15 mg q.PM
OG004
Stratum 1 : Cohort 5
Ruxolitinib was administered at a starting dose of 15 mg q.AM + 15 mg q.PM
OG005
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg q.AM + 5 mg q.PM
OG006
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM+ 10 mg q.PM
OG007
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg q.AM+ 10 mg q.PM
Units
Counts
Participants
OG0005
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Treatment Emergent Adverse Events (TEAE's)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Full Analysis Population; Multiple dose cohorts within the strata are combined based on the total dose levels as specified in Statistical Analysis Plan
Posted
Count of Participants
Participants
approximately 4 years
ID
Title
Description
OG000
Stratum 1 : Group 1
Ruxolitinib was administered to Cohort 1 (5 mg bid) + Cohort 2 (5 mg q.AM / 10 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10^9/L
OG001
Stratum 1 : Group 2
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
OG002
Stratum 1 : Group 3
Ruxolitinib was administered Cohort 4 (10 mg q.AM / 15 mg q.PM) + Cohort 5 (15 mg bid) in Participants with baseline Platelet counts of 75-99 x10^9/L.
OG003
Stratum 2 : Group 1
Secondary
Number of Subjects Achieving ≥ 50% Reduction in Palpable Spleen Length
Participants achieving ≥ 50% reduction in palpable spleen length relative to study day 1 by treatment and stratum
All participants who had spleen assessment at week 24. Multiple dose cohorts within the strata are grouped according to total daily dose ranges as specified in Statistical Analysis Plan.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
Stratum 1 : Group 1
Ruxolitinib was administered to Cohort 1 (5 mg bid) + Cohort 2 (5 mg q.AM / 10 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10^9/L
OG001
Stratum 1 : Group 2
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
OG002
Stratum 1 : Group 3
Ruxolitinib was administered Cohort 4 (10 mg q.AM / 15 mg q.PM) + Cohort 5 (15 mg bid) in Participants with baseline Platelet counts of 75-99 x10^9/L.
OG003
Stratum 2 : Group 1
Secondary
Change in Spleen Length as Measure by Palpation Over Time
Defined as measurement of change in spleen length by palpation from baseline
Change in spleen length measurement as compared to baseline are summarized by time and by stratum as specified in the SAP.
To define the PK and Tissue Necrosis Factor Receptor 2 relationship using PK Quartiles (AUC 0-12, ng*h/mL)
Results are summarized by strata, as dose relationship is accounted for by PK quartiles.
Posted
Mean
Standard Deviation
nanograms/mL
24 weeks
ID
Title
Description
OG000
Stratum 1
Participants with baseline Platelet counts of 75-99 x10^9/L
OG001
Stratum 2
Participants with baseline Platelet counts of 50-74 x10^9/L
Units
Counts
Participants
OG000
Secondary
AUC 0-Inf
Area Under the Serum Concentration Versus Time Curve，Time 0 to Infinity
Results are summarized by strata; dose relationship is accounted for by PK quartile grouping.
Posted
Mean
Standard Deviation
nM*hr
0.25 to 0.75, 1 to 3, and 4 to 12 hours postdose on Day 1 and predose, 0.25 to 0.75 hours, and 1 to 3 hours postdose on Day 15, with a random sample on Days 29 and 57
ID
Title
Description
OG000
5mg BID
ruxolitinib was administered at 5 mg BID
OG001
10mg BID
ruxolitinib was administered at 10 mg BID
OG002
15 mg BID
ruxolitinib was administered at 15 mg BID
Units
Counts
Participants
OG000
Time Frame
Up to 4 years
Description
AE additional description
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
Stratum 1 : Cohort 1
Ruxolitinib was administered at 5 mg bid in Participants with baseline Platelet counts of 75-99x10^9/L
0
5
2
5
5
5
EG001
Stratum 1 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM in Participants with baseline Platelet counts of 75-99 x10^9/L
0
3
2
3
3
3
EG002
Stratum 1 : Cohort 3
Ruxolitinib was administered to cohort 3 at 10 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
3
20
10
20
20
20
EG003
Stratum 1 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM) in Participants with baseline Platelet counts of 75-99 x10^9/L
1
4
4
4
4
4
EG004
Stratum 1 : Cohort 5
Ruxolitinib was administered at 15 mg bid in Participants with baseline Platelet counts of 75-99 x10^9/L
0
12
5
12
12
12
EG005
Stratum 2 : Cohort 1
Ruxolitinib was administered at 5 mg bid in participants with baseline Platelet counts of 50-74x10^9/L
1
3
3
3
3
3
EG006
Stratum 2 : Cohort 2
Ruxolitinib was administered at 5 mg q.AM / 10 mg q.PM) in participants with baseline Platelet counts of 50-74 x10^9/L
0
4
3
4
4
4
EG007
Stratum 2 : Cohort 3
Ruxolitinib was administered at 10 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
4
18
9
18
18
18
EG008
Stratum 2 : Cohort 4
Ruxolitinib was administered at 10 mg q.AM / 15 mg q.PM in participants with baseline Platelet counts of 50-74 x10^9/L
0
0
0
0
0
0
EG009
Stratum 2 : Cohort 5
Ruxolitinib was administered at 15 mg bid in participants with baseline Platelet counts of 50-74 x10^9/L
0
0
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG0030 affected4 at risk
EG0040 affected12 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
EG0070 affected0 at risk
EG0080 affected0 at risk
EG0090 affected0 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Asthenia
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Fatigue
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
General physical health deterioration
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Oedema peripheral
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Sudden death
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Chloroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Myelofibrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
IIIrd nerve paralysis
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Syncope
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Calculus bladder
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Bleeding varicose vein
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Haematoma
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Disseminated tuberculosis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Influenza
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Sepsis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Splenic rupture
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Transformation to acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0003 affected5 at risk
EG0012 affected3 at risk
EG00211 affected20 at risk
EG0032 affected4 at risk
EG0046 affected12 at risk
EG0051 affected3 at risk
EG0063 affected4 at risk
EG0078 affected18 at risk
EG0080 affected0 at risk
EG0090 affected0 at risk
Haemorrhagic diathesis
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0004 affected5 at risk
EG0012 affected3 at risk
EG0029 affected20 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Cataract
Eye disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Dry eye
Eye disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Uveitis
Eye disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0025 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0022 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected3 at risk
EG0026 affected20 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Intestinal dilatation
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0021 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0021 affected20 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0023 affected20 at risk
EG003
Asthenia
General disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected3 at risk
EG0023 affected20 at risk
EG003
Chest pain
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Fatigue
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0023 affected20 at risk
EG003
Feeling cold
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Hernia pain
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Influenza like illness
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0021 affected20 at risk
EG003
Oedema peripheral
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0021 affected20 at risk
EG003
Pain
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0026 affected20 at risk
EG003
Swelling face
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Genital herpes
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0024 affected20 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Oral infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0023 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0023 affected20 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0023 affected20 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0024 affected20 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Coagulation factor V level decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Coagulation factor VII level decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Coagulation factor X level decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0024 affected20 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Mean cell volume increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0023 affected20 at risk
EG003
Platelet count decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0026 affected20 at risk
EG003
Prothrombin level decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Prothrombin time shortened
Investigations
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Weight increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0021 affected20 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0025 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0022 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0022 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected3 at risk
EG0024 affected20 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected3 at risk
EG0020 affected20 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0020 affected20 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected3 at risk
EG0021 affected20 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)