Dose Escalation Study With MK-2206 in Patients With Local... | NCT00670488 | Trialant
NCT00670488
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Apr 1, 2019Actual
Enrollment
104Actual
Phase
Phase 1
Conditions
Locally Advanced Tumors
Metastatic Solid Tumors
Cancer
Neoplasms
Interventions
MK-2206
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00670488
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2206-002
Secondary IDs
ID
Type
Description
Link
2008_513
Other Identifier
Sponsor registry number
MK-2206-002
Other Identifier
Merck Protocol Number
Brief Title
Dose Escalation Study With MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors (MK-2206-002)
Official Title
A Phase I Dose Escalation Study of Oral MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jan 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
Apr 15, 2008Actual
Primary Completion Date
Jul 11, 2011Actual
Completion Date
Jul 11, 2011Actual
First Submitted Date
Apr 29, 2008
First Submission Date that Met QC Criteria
Apr 30, 2008
First Posted Date
May 1, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 11, 2018
Results First Submitted that Met QC Criteria
Jan 2, 2019
Results First Posted Date
Apr 1, 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
Jan 2, 2019
Last Update Posted Date
Apr 1, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
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
The primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs), pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be investigated.
Detailed Description
Not provided
Conditions Module
Conditions
Locally Advanced Tumors
Metastatic Solid Tumors
Cancer
Neoplasms
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
104Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-2206 30 mg QOD
Experimental
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
Participants receive 90 mg oral MK-2206 every week (QW) in repeating 4-week treatment cycles.
Drug: MK-2206
MK-2206 135 mg QW
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-2206
Drug
MK-2206 administered as an oral formulation in rising dose levels on a QOD schedule (30 mg, 60 mg, 75 mg, and 90 mg) or QW schedule (90 mg, 135 mg, 200 mg, 250 mg, and 300 mg) in repeating 4 week cycles, depending upon allocation.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was any drug-related AE, regardless of grade, leading to a dose modification of MK-2206. Dose-limiting hematologic and nonhematologic toxicities were defined differently and were based on events occurring during the first cycle of study drug administration. Hematologic DLT defined as any Grade (Gr) 4 or greater hematologic toxicity except neutropenia described as follows: Neutropenia that was Gr 4 lasting for ≥7 days, or Gr 3/Gr 4 with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment considered DLT. Gr 4 thrombocytopenia (≤25.0 x 10^9/L) was also considered DLT. Non-hematologic DLTs were defined as any Gr 3, 4, or 5 nonhematologic toxicity, with the specific exceptions of: Gr 3 nausea, vomiting, diarrhea, or dehydration occurring with inadequate supportive care and lasting <48 hours; alopecia; inadequately treated hypersensitivity reactions; and Gr 3 elevated transaminases of ≤1 week in duration. A participant could have more than one DLT.
Day 1 to Day 28 (Cycle 1)
Number of Participants With One or More Adverse Events (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the SPONSOR's product, was also an AE. The number of participants that experienced one or more AEs was reported for each dose level group.
Up to 269 days
Area Under the Concentration-time Curve of MK-2206 From Time 0 to 48 Hours (AUC0-48hr) in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. AUC 0-48hr was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
Secondary Outcomes
Measure
Description
Time Frame
Phosphorylated Protein Kinase B (pAkt) Level on Cycle 1 Day 15 (C1D15) After Treatment With MK-2206 at the Maximum Tolerated Dose (MTD)
To determine the inhibition of pAkt by MK-2206 in participants treated at the MTD, levels of Akt phosphorylated at the serine 473 residue (pAkt Ser473 Akt) were measured in snap-frozen tumors collected at baseline and Day 15 of Cycle 1 using a MesoScale enzyme-linked immunosorbent assay (ELISA). Per protocol, pAkt levels were determined only for the MK-2206 MTD (60 mg QOD) group.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy
Has normal organ function; is no greater than 2 on the ECOG Performance Scale
Has a negative blood or urine pregnancy test within 72 hours of receiving the first dose of study drug if participant is female
Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis
Exclusion Criteria:
Participant has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment
Is currently participating or has participated in a study with an investigational compound or device within 30 days
Has a primary central nervous system tumor
Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure
Is a known diabetic who is taking insulin or oral antidiabetic therapy
Is pregnant or breastfeeding or planning to become pregnant during the study
Is HIV-positive
Has known history of Hepatitis B or C or active Hepatitis A
Yap TA, Yan L, Patnaik A, Fearen I, Olmos D, Papadopoulos K, Baird RD, Delgado L, Taylor A, Lupinacci L, Riisnaes R, Pope LL, Heaton SP, Thomas G, Garrett MD, Sullivan DM, de Bono JS, Tolcher AW. First-in-man clinical trial of the oral pan-AKT inhibitor MK-2206 in patients with advanced solid tumors. J Clin Oncol. 2011 Dec 10;29(35):4688-95. doi: 10.1200/JCO.2011.35.5263. Epub 2011 Oct 24.
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was any drug-related AE, regardless of grade, leading to a dose modification of MK-2206. Dose-limiting hematologic and nonhematologic toxicities were defined differently and were based on events occurring during the first cycle of study drug administration. Hematologic DLT defined as any Grade (Gr) 4 or greater hematologic toxicity except neutropenia described as follows: Neutropenia that was Gr 4 lasting for ≥7 days, or Gr 3/Gr 4 with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment considered DLT. Gr 4 thrombocytopenia (≤25.0 x 10^9/L) was also considered DLT. Non-hematologic DLTs were defined as any Gr 3, 4, or 5 nonhematologic toxicity, with the specific exceptions of: Gr 3 nausea, vomiting, diarrhea, or dehydration occurring with inadequate supportive care and lasting <48 hours; alopecia; inadequately treated hypersensitivity reactions; and Gr 3 elevated transaminases of ≤1 week in duration. A participant could have more than one DLT.
The All Participants as Treated (APaT) population: All participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Day 1 to Day 28 (Cycle 1)
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 269 days
Description
APaT population: All participants who received at least one dose of study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing
Maximum Concentration (Cmax) of MK-2206 in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Cmax was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing
Concentration of MK-2206 After 48 Hours (C48hr) in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. C48hr was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
Days 1 and 27: predose and 48 hours after MK-2206 dosing.
Time to Maximum Concentration (Tmax) of MK-2206 in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Tmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing
Apparent Terminal Half-life (t½) of MK-2206 in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses on Day 27 of the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. t½ (Harmonic mean ± pseudo SD) was calculated and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
Day 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing.
AUC0-168hr in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. AUC 0-168 was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing
Cmax of MK-2206 in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Cmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing
C48hr of MK-2206 in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. C48hr was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
Days 1 and 22: predose and 48 hours after MK-2206 dosing
Tmax of MK-2206 in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Tmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing
t½ of MK-2206 in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. t½ (Harmonic mean ± pseudo SD) was calculated for the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
Day 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing
Baseline, Cycle 1 Day 15
Number of Participants With Confirmed Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)
Overall tumor response was assessed during the study by diagnostic anatomic imaging using RECIST. The number of participants with a confirmed Complete Response (CR: Disappearance of all target lesions) as per RECIST was reported for each dose level group.
From Cycle 1 Day 1 through the End of Study Visit (up to 6 months)
Derived
Yap TA, Yan L, Patnaik A, Tunariu N, Biondo A, Fearen I, Papadopoulos KP, Olmos D, Baird R, Delgado L, Tetteh E, Beckman RA, Lupinacci L, Riisnaes R, Decordova S, Heaton SP, Swales K, deSouza NM, Leach MO, Garrett MD, Sullivan DM, de Bono JS, Tolcher AW. Interrogating two schedules of the AKT inhibitor MK-2206 in patients with advanced solid tumors incorporating novel pharmacodynamic and functional imaging biomarkers. Clin Cancer Res. 2014 Nov 15;20(22):5672-85. doi: 10.1158/1078-0432.CCR-14-0868. Epub 2014 Sep 19.
Number of Participants With One or More Adverse Events (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the SPONSOR's product, was also an AE. The number of participants that experienced one or more AEs was reported for each dose level group.
APaT population: All participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Up to 269 days
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
Area Under the Concentration-time Curve of MK-2206 From Time 0 to 48 Hours (AUC0-48hr) in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. AUC 0-48hr was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
All participants who received MK-2206 orally QOD during Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.
Posted
Mean
Standard Deviation
nM•hr
Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
The Last Day (Day 27)/Day 1 AUC 0-48 hr Geometric Mean Ratio (GMR) was calculated as follows: Last Day (Day 27) AUC 0-48hr Geometric Mean (GM) ÷ Day 1 AUC 0-48hr GM.
AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation.
AUC0-48hr GMR
3.26
Other
OG003
Primary
Maximum Concentration (Cmax) of MK-2206 in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Cmax was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
All participants who received MK-2206 orally QOD during Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.
Posted
Mean
Standard Deviation
nM
Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.
Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation.
Cmax GMR
2.59
Other
OG003
The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.
Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation.
Primary
Concentration of MK-2206 After 48 Hours (C48hr) in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. C48hr was calculated for Day 1 and the last day of treatment in Cycle 1 (Day 27) and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
All participants who received MK-2206 orally QOD during Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.
Posted
Mean
Standard Deviation
nM
Days 1 and 27: predose and 48 hours after MK-2206 dosing.
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.
C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation.
C48hr GMR
4.33
Other
OG001
The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.
C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation.
Primary
Time to Maximum Concentration (Tmax) of MK-2206 in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Tmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
All participants who received MK-2206 orally QOD during Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.
Posted
Median
Full Range
hour
Days 1 and 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
Apparent Terminal Half-life (t½) of MK-2206 in Participants Receiving Multiple QOD Dosing
Blood samples were collected for PK analyses on Day 27 of the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. t½ (Harmonic mean ± pseudo SD) was calculated and reported for all dose levels receiving MK-2206 orally QOD (30, 60, 75, and 90 mg QOD).
All participants who received MK-2206 orally QOD on Day 27 of Cycle 1 (30, 60, 75, and 90 mg QOD) and had available PK data. Data for the MK-2206 QW dose groups (90, 135, 200, 300, 250, and 150 mg QW) are reported separately.
Posted
Mean
Standard Deviation
hour
Day 27: predose and 0.5, 1, 2, 3, 4, 6, 10, 24, and 48 hours after MK-2206 dosing.
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
AUC0-168hr in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. AUC 0-168 was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
All participants who received MK-2206 orally QW during Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.
Posted
Mean
Standard Deviation
nM•hr
Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.
AUC0-168hr GMR
1.91
Other
OG006
The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.
Primary
Cmax of MK-2206 in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Cmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
All participants who received MK-2206 orally QW during Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.
Posted
Mean
Standard Deviation
nM
Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.
Cmax GMR
1.95
Other
OG006
The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.
Primary
C48hr of MK-2206 in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. C48hr was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
All participants who received MK-2206 orally QW during Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.
Posted
Mean
Standard Deviation
nM
Days 1 and 22: predose and 48 hours after MK-2206 dosing
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.
C48hr GMR
1.61
Other
OG005
The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.
Primary
Tmax of MK-2206 in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. Tmax was calculated for Day 1 and the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
All participants who received MK-2206 orally QW during Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.
Posted
Median
Full Range
hour
Days 1 and 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
t½ of MK-2206 in Participants Receiving Multiple QW Dosing
Blood samples were collected for PK analyses during the first cycle of therapy. Samples were centrifuged, plasma was withdrawn and plasma concentrations were analyzed by high performance liquid chromatography with tandem mass spectroscopy. t½ (Harmonic mean ± pseudo SD) was calculated for the last day of treatment in Cycle 1 and reported for all dose levels receiving MK-2206 orally QW (90, 135, 200, 300, 250, and 150 mg QW).
All participants who received MK-2206 orally QW on Day 22 of Cycle 1 (90, 135, 200, 300, 250, and 150 mg QW) and had available PK data. Data for the MK-2206 QOD dose groups (30, 60, 75, and 90 mg QOD) are reported separately.
Posted
Mean
Standard Deviation
hour
Day 22: predose and 2, 4, 6, 10, 24, 48, 96 hours, and 168 hours after MK-2206 dosing
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
Phosphorylated Protein Kinase B (pAkt) Level on Cycle 1 Day 15 (C1D15) After Treatment With MK-2206 at the Maximum Tolerated Dose (MTD)
To determine the inhibition of pAkt by MK-2206 in participants treated at the MTD, levels of Akt phosphorylated at the serine 473 residue (pAkt Ser473 Akt) were measured in snap-frozen tumors collected at baseline and Day 15 of Cycle 1 using a MesoScale enzyme-linked immunosorbent assay (ELISA). Per protocol, pAkt levels were determined only for the MK-2206 MTD (60 mg QOD) group.
Participants treated at the MTD (60 mg QOD) dose level with measurable disease at baseline per RECIST and paired tumor samples at baseline and C1D15. Per protocol, no other dose level groups were analyzed.
Posted
Geometric Mean
95% Confidence Interval
pAkt lysate units/mg protein
Baseline, Cycle 1 Day 15
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
Number of Participants With Confirmed Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)
Overall tumor response was assessed during the study by diagnostic anatomic imaging using RECIST. The number of participants with a confirmed Complete Response (CR: Disappearance of all target lesions) as per RECIST was reported for each dose level group.
All participants with measurable disease at baseline per RECIST.
Posted
Count of Participants
Participants
From Cycle 1 Day 1 through the End of Study Visit (up to 6 months)
ID
Title
Description
OG000
MK-2206 30 mg QOD
Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events7 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected5 at risk
EG0062 events2 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Convulsion
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Renal failure acute
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events5 affected58 at risk
EG0020 events0 affected3 at risk
EG0034 events3 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0063 events3 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events1 affected2 at risk
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Vascular compression
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
EG0000 events0 affected3 at risk
EG0013 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected58 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Monocytopenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Atrioventricular block first degree
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Myocardial ischaemia
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Tachycardia
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Ear congestion
Ear and labyrinth disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Hypothyroidism
Endocrine disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Cataract
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Conjunctivitis
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0032 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Corneal disorder
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Dry eye
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Eye disorder
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events5 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Eye swelling
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Lens disorder
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Maculopathy
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Myopia
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Optic disc disorder
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Vision blurred
Eye disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events5 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0064 events2 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected2 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0093 events1 affected2 at risk
Ascites
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Constipation
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG00115 events10 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0064 events4 affected17 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG00111 events8 affected58 at risk
EG0021 events1 affected3 at risk
EG0036 events4 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0065 events5 affected17 at risk
EG0070 events0 affected3 at risk
EG0082 events2 affected3 at risk
EG0091 events1 affected2 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events5 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Enterocutaneous fistula
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Haematochezia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Lip pain
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Nausea
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0003 events2 affected3 at risk
EG00131 events22 affected58 at risk
EG0021 events1 affected3 at risk
EG0033 events3 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0069 events7 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0094 events1 affected2 at risk
Odynophagia
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Oral mucosal exfoliation
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected2 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0038 events5 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0063 events3 affected17 at risk
EG0071 events1 affected3 at risk
EG0082 events1 affected3 at risk
EG0090 events0 affected2 at risk
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Systematic Assessment
EG0003 events1 affected3 at risk
EG00128 events16 affected58 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0064 events4 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0094 events2 affected2 at risk
Chest discomfort
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Chest pain
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Fatigue
General disorders
MedDRA 14.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG00134 events26 affected58 at risk
EG0021 events1 affected3 at risk
EG0032 events2 affected7 at risk
EG0043 events2 affected3 at risk
EG0050 events0 affected5 at risk
EG00610 events8 affected17 at risk
EG0071 events1 affected3 at risk
EG0082 events2 affected3 at risk
EG0092 events2 affected2 at risk
Influenza like illness
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Mucosal inflammation
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Oedema peripheral
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected58 at risk
EG0022 events2 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected2 at risk
Pain
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0064 events2 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Performance status decreased
General disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Pyrexia
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0016 events4 affected58 at risk
EG0020 events0 affected3 at risk
EG0034 events3 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0062 events2 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Thirst
General disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Paronychia
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Skin infection
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Vulvovaginal candidiasis
Infections and infestations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events5 affected58 at risk
EG0022 events1 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Skin injury
Injury, poisoning and procedural complications
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Alanine aminotransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events4 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected2 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events4 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG00110 events5 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected2 at risk
Blood creatinine increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Blood lactate dehydrogenase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Transaminases increased
Investigations
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Weight decreased
Investigations
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected58 at risk
EG0022 events2 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG00122 events16 affected58 at risk
EG0022 events2 affected3 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0064 events4 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0094 events2 affected2 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG00117 events8 affected58 at risk
EG0022 events2 affected3 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0054 events1 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0016 events6 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected2 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG00110 events9 affected58 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected58 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events7 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0018 events7 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events5 affected58 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected17 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected2 at risk
Dizziness
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Dysgeusia
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Headache
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG00110 events9 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0062 events2 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected2 at risk
Sensory loss
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Somnolence
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
VIIth nerve paralysis
Nervous system disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Anxiety
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Depressed mood
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Insomnia
Psychiatric disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Renal tubular necrosis
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Gynaecomastia
Reproductive system and breast disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0019 events8 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0065 events4 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0016 events4 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0062 events2 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0062 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Hydropneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Throat tightness
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0017 events7 affected58 at risk
EG0021 events1 affected3 at risk
EG0033 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0062 events2 affected17 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected2 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG00111 events8 affected58 at risk
EG0022 events2 affected3 at risk
EG0032 events2 affected7 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected5 at risk
EG0063 events2 affected17 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected2 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG00141 events26 affected58 at risk
EG0025 events3 affected3 at risk
EG0034 events4 affected7 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected5 at risk
EG00613 events5 affected17 at risk
EG0078 events3 affected3 at risk
EG0085 events2 affected3 at risk
EG0093 events2 affected2 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected2 at risk
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
Aneurysm
Vascular disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected17 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected2 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
3
BG0051
BG00610
BG0071
BG0082
BG0091
BG01055
3
OG0040
OG0050
OG0063
OG0072
OG0082
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
1
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
1
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
0
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
4
OG0040
OG0050
OG0064
OG0073
OG0082
OG0091
7
OG0043
OG0055
OG00617
OG0073
OG0083
OG0092
7
OG0043
OG0055
OG00617
OG0073
OG0083
OG0092
7
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
7
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000916± 395
OG0011950± 832
OG0022110± 782
OG0033950± 1920
Last Day (Day 27)
ParticipantsOG0001
ParticipantsOG00144
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000NA± NAAUC0-48 hr could not be determined due to insufficient data.
OG0016160± 2690
OG002NA± NAAUC0-48 hr could not be determined due to insufficient data.
OG003
The Last Day (Day 27)/Day 1 AUC 0-48 hr GMR was calculated as follows: Last Day (Day 27) AUC 0-48hr GM ÷ Day 1 AUC 0-48hr GM.
AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation.
AUC 0-48hr GMR
3.18
Other
7
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
7
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00033.7± 15.8
OG00171.6± 36.3
OG002102± 79.9
OG003132± 76.5
Last Day (Day 27)
ParticipantsOG0001
ParticipantsOG00144
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000NA± NACmax could not be determined due to insufficient data.
OG001176± 77.9
OG002NA± NACmax could not be determined due to insufficient data.
OG003
Cmax GMR
2.67
Other
7
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
7
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00014.1± 5.38
OG00130.9± 14.4
OG00230.6± 12.0
OG00364.1± 28.0
Last Day (Day 27)
ParticipantsOG0001
ParticipantsOG00144
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00067.9± NAStandard Deviation could not be calculated since the N=1.
OG001100± 45.6
OG002110± NAStandard Deviation could not be calculated since the N=1.
OG003
C48hr GMR
3.58
Other
7
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
7
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0006.0(4.0 to 6.0)
OG0014.0(2.0 to 24.0)
OG0026.0(4.0 to 6.0)
OG0036.0(4.0 to 10.0)
Last Day (Day 27)
ParticipantsOG0001
ParticipantsOG00144
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0004.0(4.0 to 4.0)
OG0016.0(3.0 to 24.0)
OG00210.0(10.0 to 10.0)
OG003
2
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
65.6
± 0
0
OG0043
OG0055
OG00617
OG0073
OG0083
OG0092
0
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG00617
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
Title
Measurements
OG0046510± 3810
OG00512000± 4610
OG00616400± 5470
OG00727700± 3320
OG00814000± 2950
OG00920700± 0
Last Day (Day 22)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG00613
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
Title
Measurements
OG00410600± 7520
OG00520700± 8780
OG00623500± 14700
OG008
AUC 0-168hr GMR
1.54
Other
0
OG0043
OG0055
OG00617
OG0073
OG0083
OG0092
0
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG00617
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
Title
Measurements
OG00481.7± 42.4
OG005199± 98.9
OG006264± 75.8
OG007466± 123
OG008231± 39.1
OG009337± 0
Last Day (Day 22)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG00613
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
Title
Measurements
OG004153± 98.0
OG005352± 210
OG006345± 199
OG008
Cmax GMR
1.33
Other
0
OG0043
OG0055
OG00617
OG0073
OG0083
OG0092
0
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG00617
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
Title
Measurements
OG00450.9± 38.2
OG00590.3± 25.1
OG006121± 47.4
OG007253± 0
OG008103± 19.6
OG009155± 0
Last Day (Day 22)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG00613
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
Title
Measurements
OG00479.3± 33.7
OG005158± 59.2
OG006187± 113
OG008
C48hr GMR
1.86
Other
OG006
The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.
C48hr GMR
1.49
Other
0
OG0043
OG0055
OG00617
OG0073
OG0083
OG0092
0
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG00617
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
Title
Measurements
OG0046.0(4.0 to 10.0)
OG0054.0(4.0 to 10.0)
OG0066.0(4.0 to 10.0)
OG0074.0(4.0 to 6.0)
OG0086.0(4.0 to 6.0)
OG0097.0(4.0 to 10.0)
Last Day (Day 22)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG00613
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
Title
Measurements
OG0044.0(4.0 to 4.0)
OG0055.0(4.0 to 24.0)
OG0066.0(4.0 to 24.0)
OG008
0
OG0043
OG0054
OG00613
OG0070
OG0081
OG0091
53.7
± 0
OG00964.4± 0
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
7
OG0043
OG0055
OG00617
OG0073
OG0083
OG0092
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
7970
± 5990
232
± 148
134
± 112
5.0
(4.0 to 6.0)
10700
± NA
Standard Deviation could not be calculated since the N=1.
OG00922600± 0
169
± NA
Standard Deviation could not be calculated since the N=1.
OG009346± NAStandard Deviation could not be calculated since the N=1.