A Phase 1 Study of MDV3100 in Patients With Castration-Re... | NCT00510718 | Trialant
NCT00510718
Sponsor
Pfizer
Status
Completed
Last Update Posted
Oct 3, 2019Actual
Enrollment
140Actual
Phase
Phase 1
Conditions
Prostate Cancer
Hormone Refractory Prostate Cancer
Interventions
MDV3100
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00510718
Obsolete or Duplicate NCT IDs
NCT00513812
Organization Study
S-3100-1-01
Secondary IDs
ID
Type
Description
Link
C3431009
Other Identifier
Alias Study Number
Brief Title
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
Official Title
A PHASE 1, OPEN-LABEL, DOSE-ESCALATION SAFETY AND PHARMACOKINETIC STUDY OF MDV3100 IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Sep 2019
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 23, 2007Actual
Primary Completion Date
Dec 8, 2008Actual
Completion Date
Apr 2, 2018Actual
First Submitted Date
Jul 31, 2007
First Submission Date that Met QC Criteria
Jul 31, 2007
First Posted Date
Aug 2, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 20, 2019
Results First Submitted that Met QC Criteria
Sep 10, 2019
Results First Posted Date
Oct 3, 2019Actual
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
Sep 10, 2019
Last Update Posted Date
Oct 3, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Astellas Pharma Inc
INDUSTRY
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
Detailed Description
This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.
Conditions Module
Conditions
Prostate Cancer
Hormone Refractory Prostate Cancer
Keywords
Prostate
Cancer
Hormone
Refractory
Castration
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
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
140Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
MDV3100
Drug: MDV3100
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MDV3100
Drug
MDV3100 daily until progression or dose-limiting toxicity
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.
Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period
DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.
Baseline up to first 35 days of the study treatment in multiple dose period
Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period
Tolerability was defined as if less than (<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and < 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if <8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.
Baseline up to first 35 days of the study treatment in multiple dose period
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period
Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post dose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants With Prostate Specific Antigen (PSA) Response at Day 84: Multiple Dose Period
Prostate-specific antigen is a glycoprotein considered as a biomarker for the response to therapy in men with prostate cancer. A 50 percent (%) decline in PSA from baseline to the PSA level at Day 84 was considered as a PSA response.
Baseline, Day 84
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate;
Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
Progressive disease after medical or surgical castration,
Exclusion Criteria:
1. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);
Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
Scher HI, Beer TM, Higano CS, Anand A, Taplin ME, Efstathiou E, Rathkopf D, Shelkey J, Yu EY, Alumkal J, Hung D, Hirmand M, Seely L, Morris MJ, Danila DC, Humm J, Larson S, Fleisher M, Sawyers CL; Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010 Apr 24;375(9724):1437-46. doi: 10.1016/S0140-6736(10)60172-9. Epub 2010 Apr 14.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MDV3100 (Enzalutamide): No Previous Chemotherapy
Participants with no prior exposure to chemotherapy received single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 milligram per day (mg/day) dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the maximum tolerated dose (MTD) was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, dose limiting toxicity (DLT) or disease progression occurred. Participants were followed up for 30 days after last dose of study drug for safety follow up.
Periods
Title
Milestones
Reasons Not Completed
Single Dose Period: 1 Week
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
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
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Not provided
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
enzalutamide
Xtandi
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours postdose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period
T 1/2 is the time measured for the plasma concentration of MDV3100 to decrease by one half.
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period
Volume of distribution is defined as the theoretical volume in which the total amount of MDV3100 would need to be uniformly distributed to produce the desired plasma concentration of MDV3100. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period
Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period
Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period
Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period
Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period
Pre-dose on Day 1 of Multiple Dose Period
Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period
Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
Boston
Massachusetts
02215
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
MSKCC- Sidney Kimmel Center
New York
New York
10065
United States
Oregon Health & Science University
Portland
Oregon
97239
United States
Investigational Pharmacy Services
Houston
Texas
77030-4009
United States
The University of Texas M.D. Anderson Cancer Center
Houston
Texas
77030-4009
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
University of Washington Medical Center
Seattle
Washington
98195
United States
FG001
MDV3100 (Enzalutamide): Post Chemotherapy
Participants with prior exposure to chemotherapy single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 mg/day dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the MTD was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period, for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, DLT or disease progression occurred. Participants were followed up for 30 days after last dose.
FG00015 subjects
FG00112 subjects
30 mg/Day
FG0003 subjects
FG0010 subjects
60 mg/Day
FG0003 subjects
FG0010 subjects
150/160 mg/Day
FG0002 subjects
FG0011 subjects
240 mg/Day
FG0003 subjects
FG0010 subjects
360 mg/Day
FG0004 subjects
FG0012 subjects
480 mg/Day
FG0000 subjects
FG0016 subjects
600 mg/Day
FG0000 subjects
FG0013 subjects
COMPLETED
FG00015 subjects
FG00112 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Multiple Dose Period: 12 Weeks
Type
Comment
Milestone Data
STARTED
FG00065 subjectsParticipants who completed single dose period + new participants enrolled in multiple dose period.
FG00175 subjectsParticipants who completed single dose period + new participants enrolled in multiple dose period.
30 mg/Day
FG0003 subjects
FG0010 subjects
60 mg/Day
FG00015 subjects
FG00112 subjects
150/160 mg/Day
FG00015 subjects
FG00113 subjects
240 mg/Day
FG00017 subjects
FG00112 subjects
360 mg/Day
FG00015 subjects
FG00113 subjects
480 mg/Day
FG0000 subjects
FG00122 subjects
600 mg/Day
FG0000 subjects
FG0013 subjects
COMPLETED
FG00050 subjects
FG00143 subjects
NOT COMPLETED
FG00015 subjects
FG00132 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0018 subjects
PSA Disease Progression
FG0003 subjects
FG001
Safety population included all enrolled participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
BG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
BG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
BG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
BG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
BG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
BG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG00127
BG00228
BG00329
BG00428
BG00522
BG0063
BG007140
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
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.
Safety population included all enrolled participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG007
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
Units
Counts
Participants
OG0003
OG00127
OG00228
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0016
OG00214
OG003
Primary
Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period
DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.
Safety population included all enrolled participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
Baseline up to first 35 days of the study treatment in multiple dose period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Primary
Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period
Tolerability was defined as if less than (<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and < 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if <8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.
Safety population included all enrolled participants who received at least 1 dose of study drug.
Posted
Number
milligrams per day
Baseline up to first 35 days of the study treatment in multiple dose period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) : All Participants
Participants received single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 mg/day dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the MTD was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period for 84 days.
Units
Counts
Participants
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period
Pharmacokinetic (PK) evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour per milliliter
Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post dose on Day 1 of Single Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour per milliliter
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours postdose on Day 1 of Single Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour per milliliter
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter.
Posted
Median
Full Range
hours
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
OG003
Secondary
Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period
T 1/2 is the time measured for the plasma concentration of MDV3100 to decrease by one half.
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
hours
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period
Volume of distribution is defined as the theoretical volume in which the total amount of MDV3100 would need to be uniformly distributed to produce the desired plasma concentration of MDV3100. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Secondary
Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period
Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters per hour
Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour per milliliter
Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Median
Full Range
hours
Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter
Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
microgram per milliliter
Pre-dose on Day 1 of Multiple Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Secondary
Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period
Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
liters per hour
Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose Period
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Other Pre-specified
Percentage of Participants With Prostate Specific Antigen (PSA) Response at Day 84: Multiple Dose Period
Prostate-specific antigen is a glycoprotein considered as a biomarker for the response to therapy in men with prostate cancer. A 50 percent (%) decline in PSA from baseline to the PSA level at Day 84 was considered as a PSA response.
Analysis population included all enrolled participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline, Day 84
ID
Title
Description
OG000
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
Time Frame
Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
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
MDV3100 (Enzalutamide) 30 mg/Day
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
0
3
3
3
EG001
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
6
27
27
27
EG002
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
14
28
27
28
EG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
8
29
29
29
EG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
6
28
28
28
EG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
1
22
21
22
EG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
1
3
3
3
EG007
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
10
18
17
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG0030 affected29 at risk
EG0042 affected28 at risk
EG0050 affected22 at risk
EG0060 affected3 at risk
EG0070 affected18 at risk
Myocardial infarction
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Fatigue
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Asthenia
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Chest pain
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Pyrexia
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Localised oedema
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Oedema peripheral
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Pain
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Device related infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Metastatic pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0022 affected28 at risk
EG003
Convulsion
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Nerve root compression
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Aphasia
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Leukoencephalopathy
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Pyramidal tract syndrome
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Coronary artery thrombosis
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hepatic cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Lung squamous cell carcinoma stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypertension
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypotension
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Syncope
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0015 affected27 at risk
EG0023 affected28 at risk
EG0034 affected29 at risk
EG0043 affected28 at risk
EG0052 affected22 at risk
EG0060 affected3 at risk
EG0071 affected18 at risk
Coronary artery disease
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Nodal rhythm
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dry eye
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Vision blurred
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected27 at risk
EG0021 affected28 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0013 affected27 at risk
EG0021 affected28 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG00110 affected27 at risk
EG0028 affected28 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0017 affected27 at risk
EG0028 affected28 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Intestinal mass
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0015 affected27 at risk
EG0023 affected28 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Asthenia
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0024 affected28 at risk
EG003
Chest discomfort
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Chest pain
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0023 affected28 at risk
EG003
Chills
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Face oedema
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Facial pain
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Fatigue
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG00117 affected27 at risk
EG00219 affected28 at risk
EG003
Feeling abnormal
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Feeling cold
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Gait disturbance
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0023 affected28 at risk
EG003
Influenza like illness
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Irritability
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Local swelling
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Localised oedema
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Malaise
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Mass
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Mucosal dryness
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Mucosal inflammation
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Nodule
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Oedema
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Oedema peripheral
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0016 affected27 at risk
EG0029 affected28 at risk
EG003
Pain
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0014 affected27 at risk
EG0022 affected28 at risk
EG003
Pyrexia
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0014 affected27 at risk
EG0024 affected28 at risk
EG003
Sluggishness
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Thirst
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hepatosplenomegaly
Hepatobiliary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Axillary candidiasis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Blastocystis infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0023 affected28 at risk
EG003
Candidiasis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Cystitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Ear infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Eye infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Furuncle
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Influenza
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Localised infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Sepsis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Tinea infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0024 affected28 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0020 affected28 at risk
EG003
Viral infection
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Medical device pain
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Post procedural haematuria
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0022 affected28 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Tongue injury
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Blood calcium increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0021 affected28 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Blood potassium decreased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Blood potassium increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Blood pressure increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Blood urea increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Bone density decreased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Cardiac murmur
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Electrocardiogram QT corrected interval prolonged
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0024 affected28 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Heart rate increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Heart rate irregular
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Immunoglobulins increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Light chain analysis increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Neutrophil count increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Occult blood positive
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Urine output decreased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Weight decreased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0016 affected27 at risk
EG0021 affected28 at risk
EG003
Weight increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0020 affected28 at risk
EG003
White blood cell count increased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0016 affected27 at risk
EG0028 affected28 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0016 affected27 at risk
EG0023 affected28 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG00111 affected27 at risk
EG0028 affected28 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG00111 affected27 at risk
EG0025 affected28 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0022 affected28 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0014 affected27 at risk
EG0022 affected28 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0022 affected28 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0022 affected28 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0023 affected28 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0019 affected27 at risk
EG0022 affected28 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0023 affected28 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0014 affected27 at risk
EG0022 affected28 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0019 affected27 at risk
EG0026 affected28 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0022 affected28 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Adenoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Amnesia
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0020 affected28 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Clumsiness
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0021 affected28 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0022 affected28 at risk
EG003
Cranial nerve disorder
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0014 affected27 at risk
EG0027 affected28 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0025 affected28 at risk
EG003
Headache
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0016 affected27 at risk
EG0022 affected28 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected27 at risk
EG0023 affected28 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Judgement impaired
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0023 affected28 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Mental retardation severity unspecified
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Migraine
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Neuropathy
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0021 affected28 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0022 affected28 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected27 at risk
EG0023 affected28 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Syncope vasovagal
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Tremor
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Vertigo positional
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Agitation
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0022 affected28 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Depression
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Impatience
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0015 affected27 at risk
EG0022 affected28 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Phobia
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Bladder pain
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Costovertebral angle tenderness
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected27 at risk
EG0021 affected28 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0014 affected27 at risk
EG0021 affected28 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Incontinence
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0022 affected28 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0015 affected27 at risk
EG0022 affected28 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0013 affected27 at risk
EG0024 affected28 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Urethral haemorrhage
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Urethral pain
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0023 affected28 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Genital erythema
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Penile pain
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0016 affected27 at risk
EG0025 affected28 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0019 affected27 at risk
EG0027 affected28 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0023 affected28 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected27 at risk
EG0022 affected28 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0014 affected27 at risk
EG0022 affected28 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0021 affected28 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0022 affected28 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0023 affected28 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0022 affected28 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0021 affected28 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Hair growth abnormal
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0024 affected28 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypoaesthesia facial
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0022 affected28 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Penile ulceration
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0014 affected27 at risk
EG0023 affected28 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Skin odour abnormal
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Flushing
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Hot flush
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0017 affected27 at risk
EG0027 affected28 at risk
EG003
Hypertension
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0022 affected28 at risk
EG003
Hypotension
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Temporal arteritis
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Atrophy
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Cyst
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Injection site nodule
General disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Ear infection staphylococcal
Infections and infestations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Vitamin D decreased
Investigations
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0013 affected27 at risk
EG0020 affected28 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Cubital tunnel syndrome
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Presyncope
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Syncope
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Balanitis
Reproductive system and breast disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Schamberg's disease
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Vascular pseudoaneurysm
Vascular disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Right ventricular hypertrophy
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Spondylolisthesis
Congenital, familial and genetic disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Hearing impaired
Ear and labyrinth disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Blepharitis
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Diplopia
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Ectropion
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Eye pain
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Eye swelling
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Glare
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Ocular icterus
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Photophobia
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Refraction disorder
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Visual disturbance
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0021 affected28 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected27 at risk
EG0020 affected28 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Dental discomfort
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected27 at risk
EG0022 affected28 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Faecal volume decreased
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected27 at risk
EG0022 affected28 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected27 at risk
EG0021 affected28 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Lip exfoliation
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0016 affected27 at risk
EG00211 affected28 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0020 affected28 at risk
EG003
Oral soft tissue disorder
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Pruritus ani
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected27 at risk
EG0021 affected28 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0020 affected28 at risk
EG003
Tongue coated
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected27 at risk
EG0021 affected28 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D011471
Prostatic Neoplasms
D009369
Neoplasms
Ancestor Terms
ID
Term
D005834
Genital Neoplasms, Male
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D005832
Genital Diseases, Male
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D011469
Prostatic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C540278
enzalutamide
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
6 subjects
Radiologic Disease Progression
FG0008 subjects
FG00111 subjects
Clinical Disease Progression
FG0001 subjects
FG0013 subjects
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
Other
FG0001 subjects
FG0011 subjects
0
BG0040
BG0050
BG0060
BG0070
Between 18 and 65 years
BG0001
BG00115
BG00210
BG0038
BG00410
BG0057
BG0063
BG00754
>=65 years
BG0002
BG00112
BG00218
BG00321
BG00418
BG00515
BG0060
BG00786
0
BG0030
BG0040
BG0050
BG0060
BG0070
Male
BG0003
BG00127
BG00228
BG00329
BG00428
BG00522
BG0063
BG007140
0
BG0031
BG0041
BG0050
BG0060
BG0075
Not Hispanic or Latino
BG0003
BG00124
BG00228
BG00327
BG00427
BG00522
BG0063
BG007134
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0071
0
BG0030
BG0041
BG0050
BG0060
BG0071
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Black or African American
BG0000
BG0011
BG0020
BG0031
BG0042
BG0050
BG0060
BG0074
White
BG0003
BG00126
BG00228
BG00328
BG00425
BG00522
BG0063
BG007135
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
29
OG00428
OG00522
OG0063
OG00718
8
OG0046
OG0051
OG0061
OG00710
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG00127
OG00228
OG00329
OG00428
OG00522
OG0063
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0062
OG000140
Title
Denominators
Categories
Title
Measurements
OG000240
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0046
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG0005.43± 11.80
OG00115.64± 3.50
OG00238.21± 23.64
OG00358.39± 47.64
OG00479.26± 19.29
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0054
OG0063
Title
Denominators
Categories
Title
Measurements
OG00021.2± 14.2
OG00153.1± 4.1
OG002145.3± 10.0
OG003208.5± 44.0
OG004320.2± 12.9
OG005363.4± 38.7
OG006391.9± 14.0
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0045
OG0054
OG0063
Title
Denominators
Categories
Title
Measurements
OG00051.3± 39.8
OG00192.7± 19.0
OG002331.5± 14.6
OG003459.2± 32.7
OG004706.7± 17.7
OG005952.7± 42.4
OG006865.0± 34.6
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0046
OG0056
OG0063
Title
Denominators
Categories
Title
Measurements
OG0001.98(0.42 to 4.00)
OG0010.50(0.48 to 1.00)
OG0020.53(0.50 to 1.98)
OG0031.00(0.57 to 1.00)
OG0041.03(0.53 to 2.20)
OG0051.54(0.53 to 2.08)
OG0061.03(1.03 to 2.00)
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0046
OG0056
OG0063
Title
Denominators
Categories
Title
Measurements
OG0000.43± 15.97
OG0011.65± 28.77
OG0023.30± 22.85
OG0035.19± 18.64
OG0046.68± 39.61
OG0055.93± 66.03
OG0065.17± 19.51
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0045
OG0054
OG0063
Title
Denominators
Categories
Title
Measurements
OG000164.9± 69.8
OG001100.5± 30.9
OG002143.7± 34.8
OG003138.9± 22.6
OG004149.1± 26.1
OG005144.0± 68.4
OG006130.4± 37.7
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0045
OG0054
OG0063
Title
Denominators
Categories
Title
Measurements
OG000131.7± 15.6
OG00190.5± 16.0
OG00291.89± 13.31
OG003103.8± 48.5
OG004108.2± 15.8
OG00597.4± 30.7
OG006126.4± 8.8
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0045
OG0054
OG0063
Title
Denominators
Categories
Title
Measurements
OG0000.585± 39.810
OG0010.647± 18.988
OG0020.453± 14.583
OG0030.523± 32.679
OG0040.509± 17.711
OG0050.504± 42.437
OG0060.694± 34.625
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG00120
OG00222
OG00329
OG00414
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG00060.0± 21.0
OG001109.8± 34.4
OG002291.7± 24.9
OG003395.7± 27.4
OG004488.9± 23.9
OG005463.1± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG00121
OG00223
OG00329
OG00416
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG0002.07(1.00 to 3.92)
OG0011.07(0.50 to 23.67)
OG0021.00(0.00 to 25.80)
OG0031.08(0.00 to 26.17)
OG0041.57(0.48 to 24.08)
OG0050.00(0.00 to 0.00)
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG00121
OG00223
OG00329
OG00416
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG0002.76± 21.10
OG0015.49± 28.88
OG00214.07± 25.36
OG00318.91± 26.57
OG00424.57± 21.00
OG00527.90± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG00122
OG00224
OG00325
OG00421
OG00516
OG0063
Title
Denominators
Categories
Title
Measurements
OG0000.10± 0.03
OG0010.00± 0.00
OG0020.04± 0.19
OG0030.00± 0.00
OG0040.00± 0.00
OG0050.00± 0.00
OG0061.89± 0.55
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
Units
Counts
Participants
OG0003
OG00120
OG00222
OG00329
OG00414
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG0000.507± 0.111
OG0010.580± 0.245
OG0020.530± 0.149
OG0030.628± 0.179
OG0040.755± 0.176
OG0051.037± NAStandard deviation could not be estimated as only 1 participant was analyzed.
OG003
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG004
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG005
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
OG006
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.