Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Pati... | NCT01465802 | Trialant
NCT01465802
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 9, 2019Actual
Enrollment
236Actual
Phase
Phase 2
Conditions
Non Small Cell Lung Cancer (NSCLC)
Interventions
Dacomitinib
Dacomitinib
Doxycycline
Probiotic
Alclometasone cream
Countries
United States
South Korea
Protocol Section
Identification Module
NCT ID
NCT01465802
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A7471042
Secondary IDs
Not provided
Brief Title
Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO
Official Title
ARCHER 1042: A PHASE 2 STUDY OF DACOMITINIB IN ADVANCED NON-SMALL CELL LUNG CANCER (POST-CHEMOTHERAPY OR SELECT FIRST LINE PATIENTS) TO EVALUATE PROPHYLACTIC INTERVENTION ON DERMATOLOGIC AND GASTROINTESTINAL ADVERSE EVENTS AND PATIENT REPORTED OUTCOMES
Acronym
ARCHER 1042
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Dec 2018
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
Dec 26, 2011Actual
Primary Completion Date
May 18, 2015Actual
Completion Date
May 18, 2015Actual
First Submitted Date
Oct 20, 2011
First Submission Date that Met QC Criteria
Nov 2, 2011
First Posted Date
Nov 7, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 15, 2016
Results First Submitted that Met QC Criteria
Jul 7, 2016
Results First Posted Date
Aug 17, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 14, 2015
Certification/Extension First Submitted that Passed QC Review
Dec 14, 2015
Certification/Extension First Posted Date
Jan 14, 2016Estimated
Last Update Submitted Date
Dec 20, 2018
Last Update Posted Date
Jan 9, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
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
To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).
Detailed Description
Not provided
Conditions Module
Conditions
Non Small Cell Lung Cancer (NSCLC)
Keywords
non-small cell lung cancer
advanced
previously treated
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
236Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort I
Experimental
Arm A: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline placebo orally BID for 4 weeks Arm B: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline 100 mg orally BID for 4 weeks
Drug: Dacomitinib
Drug: Doxycycline
Cohort II
Experimental
Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)
Drug: Dacomitinib
Drug: Probiotic
Drug: Alclometasone cream
Cohort III
Experimental
Cohort III is an interrupted dosing schedule of dacomitinib in the first cycle only
Drug: Dacomitinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dacomitinib
Drug
Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent
Cohort I
Cohort II
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I
SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.
95% confidence interval (CI) calculated using exact method based on binomial distribution.
After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C.
First 8 Weeks of Treatment
Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I
SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).
95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C.
First 8 Weeks of Treatment
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I
Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) & disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.
Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III
Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Advanced Non-Small Cell Lung Cancer (NSCLC).
For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.
For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12 months prior to enrollment.
All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Estimated creatinine clearance ≥15 mL/min.
Exclusion Criteria:
Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).
Patients with known diffuse interstitial lung disease (all cohorts).
Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
City of Hope
Duarte
California
91010
United States
St. Jude Heritage Healthcare
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Puerto Rico
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Dacomitinib
Drug
Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent
Cohort III
Doxycycline
Drug
Doxycycline or Doxycycline placebo BID for 4 weeks
Cohort I
Probiotic
Drug
VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)
Cohort II
Alclometasone cream
Drug
Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks
Cohort II
First 8 Weeks of Treatment
Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II
Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.
95% CI calculated using exact method based on binomial distribution.
First 8 Weeks of Treatment
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II
Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.
Modified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).
M/T = mouth and throat.
Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up
Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II
SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.
95% CI calculated using exact method based on binomial distribution.
First 8 Weeks of Treatment
Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II
SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.
95% CI calculated using exact method based on binomial distribution.
First 8 Weeks of Treatment
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II
PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if > 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.
Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.
Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up
Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.
ng*hr/mL = nanogram hours per milliliter
Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter
Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.
Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)
Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.
Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
Cmax was obtained from direct inspection of the data.
Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.
Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I
CL/F was calculated as dose/AUCtau.
Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III
Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.
Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.
Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III
Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.
Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.
Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.
Fullerton
California
92835
United States
UCLA Hematology Oncology
Irvine
California
92604
United States
UC San Diego Medical Center - La Jolla
La Jolla
California
92037
United States
UC San Diego Moores Cancer Center - Investigational Drug Services
La Jolla
California
92037
United States
UC San Diego Moores Cancer Center
La Jolla
California
92093
United States
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles
California
90095-7349
United States
Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.
Los Angeles
California
90095
United States
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles
California
90095
United States
Drug Managment Only: UCLA West Medical Pharmacy
Los Angeles
California
90095
United States
Regulatory Management Only TRIO-US Central Administration
Los Angeles
California
90095
United States
Regulatory Management Only: TRIO-US Central Administration
Los Angeles
California
90095
United States
Ronald Reagan UCLA Medical Center
Los Angeles
California
90095
United States
UCLA Hematology Oncology
Los Angeles
California
90095
United States
Westwood Bowyer Clinic
Los Angeles
California
90095
United States
UCLA/Pasadena HealthCare
Pasadena
California
91105
United States
UC San Diego Medical Center - Hillcrest
San Diego
California
92103
United States
Coastal Integrative Cancer Care
San Luis Obispo
California
93401
United States
SANSUM Clinic
Santa Barbara
California
93105
United States
Cancer Center of Santa Barbara with SANSUM Clinic
Santa Barbara
California
93150
United States
Central Coast Medical Oncology Corporation
Santa Maria
California
93454
United States
UCLA Hematology Oncology
Santa Monica
California
90404
United States
UCLA Santa Monica Medical Center & Orthopaedic Hospital
Santa Monica
California
90404
United States
Cancer Center of Santa Barbara with SANSUM Clinic
Solvang
California
93463
United States
City of Hope South Pasadena Cancer Center
South Pasadena
California
91030
United States
UCLA/Santa Clarita Valley Cancer Center
Valencia
California
91355
United States
UCLA Cancer Center
Westlake Village
California
91361
United States
Kaiser Permanente Colorado - Franklin
Denver
Colorado
80205
United States
St. Mary's Hospital Regional Cancer Center
Grand Junction
Colorado
81501
United States
Kaiser Permanente Colorado - Rock Creek
Lafayette
Colorado
80026
United States
Kaiser Permanente Colorado - Lonetree
Lonetree
Colorado
80124
United States
Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
Fort Lauderdale
Florida
33308
United States
Memorial Cancer Institute
Hollywood
Florida
33021
United States
Cancer Care of North Florida, PA
Lake City
Florida
32024
United States
Memorial West Cancer Institute
Pembroke Pines
Florida
33028
United States
University Cancer & Blood Center, LLC
Athens
Georgia
30607
United States
Summit Cancer Care,PC
Savannah
Georgia
31404
United States
Summit Cancer Care, PC
Savannah
Georgia
31405
United States
Rush University Medical Center, Division of Hematology & Oncology
Chicago
Illinois
60612
United States
Ships Drugs to: Emmanuel Semmes, RPh (or Ami Patel, Pharm D) University of Chicago
Chicago
Illinois
60637
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
Illinois CancerCare, P.C.
Peoria
Illinois
61615
United States
Cancer Center of Kansas
Wichita
Kansas
67208
United States
Cancer Center of Kansas
Wichita
Kansas
67214
United States
Josephine Ford Cancer Center-Downriver
Brownstown
Michigan
48183
United States
Henry Ford Medical Center - Fairlane
Dearborn
Michigan
48126
United States
Henry Ford Hospital
Detroit
Michigan
48202
United States
Henry Ford Medical Center - Columbus
Novi
Michigan
48377
United States
Henry Ford Hospital and Medical Center - West Bloomfield
West Bloomfield
Michigan
48322
United States
The West Clinic, PC
Corinth
Mississippi
38834
United States
The West Clinic, PC
Southaven
Mississippi
38671
United States
Mercy Clinic Cancer & Hematology-Branson
Branson
Missouri
65616
United States
Mercy Hospital Springfield
Springfield
Missouri
65804
United States
Mercy Clinic Cancer and Hematology - Chub O-Reilly Cancer Center
Springfield
Missouri
65807
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89128
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89169
United States
Saint Barnabas Medical Center
Livingston
New Jersey
07039
United States
Beth Israel Medical Center
New York
New York
10003
United States
Beth Israel Comprehensive Cancer Center
New York
New York
10011
United States
Columbia University Medical Center - The New York Presbyterian Hospital
New York
New York
10032
United States
Stony Brook University Medical Center-Cancer Center
Stony Brook
New York
11794-9447
United States
Montefiore-Einstein Center for Cancer Care
The Bronx
New York
10461
United States
Montefiore Medical Center
The Bronx
New York
10467
United States
Carolina Oncology Specialists, PA
Hickory
North Carolina
28602
United States
Wake Forest University Health Sciences
Winston-Salem
North Carolina
27157
United States
Legacy Pharma Research
Bismarck
North Dakota
58501
United States
Mid Dakota Clinic, PC
Bismarck
North Dakota
58501
United States
St Alexius Medical Center
Bismarck
North Dakota
58501
United States
Charleston Hematology Oncology Associates, PA
Charleston
South Carolina
29414
United States
The West Clinic, PC
Memphis
Tennessee
38104
United States
The West Clinic, PC
Memphis
Tennessee
38120
United States
Investigational Product Center (IPC)
Fort Worth
Texas
76177
United States
Investigational Products Center (IPC)
Fort Worth
Texas
76177
United States
'Fletcher Allen Health Care, Inc
Burlington
Vermont
05401
United States
Office of Clinical Trials Research, Fletcher Allen Health Care, Inc.
Burlington
Vermont
05405
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
Swedish Cancer Institute - Issaquah
Issaquah
Washington
98029
United States
Swedish Cancer Institute
Seattle
Washington
98104
United States
Swedish Medical Center
Seattle
Washington
98122
United States
Seoul National University Hospital
Seoul
110-744
South Korea
Severance Hospital, Yonsei University Health System
Seoul
120-752
South Korea
FG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
FG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
FG003
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
FG004
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
FG00066 subjects
FG00166 subjects
FG0027 subjects
FG00367 subjectsAn additional 5 participants were enrolled in Cohort II but not treated.
FG00425 subjects
COMPLETED
FG00033 subjects
FG00142 subjects
FG0027 subjects
FG00338 subjects
FG00413 subjects
NOT COMPLETED
FG00033 subjects
FG00124 subjects
FG0020 subjects
FG00329 subjects
FG00412 subjects
Type
Comment
Reasons
Study terminated by sponsor
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0047 subjects
Withdrawal by Subject
FG0007 subjects
FG0017 subjects
FG0020 subjects
FG0038 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Reason not specified
FG0009 subjects
FG0014 subjects
FG0020 subjects
FG00310 subjects
FG004
Death
FG00015 subjects
FG00112 subjects
FG0020 subjects
FG00310 subjects
FG004
As Treated Population - included all participants who received at least 1 dose of study treatment assigned at enrollment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
BG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
BG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
BG003
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
BG004
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00066
BG00166
BG0027
BG00367
BG00425
BG005231
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00065.0± 10.38
BG00164.4± 10.55
BG00261.3± 7.67
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00038
BG00127
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I
SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.
95% confidence interval (CI) calculated using exact method based on binomial distribution.
After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C.
Evaluable Population - included all participants who received the study treatment assigned at enrollment, but did not discontinue dacomitinib treatment less than 6 weeks from first dosing due to either disease progression or death.
Posted
Number
95% Confidence Interval
Percentage of Participants
First 8 Weeks of Treatment
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
Units
Counts
Participants
OG00058
OG00156
Title
Denominators
Categories
Title
Measurements
OG00079.3(66.6 to 88.8)
OG00175.0(61.6 to 85.6)
Primary
Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I
SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).
95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C.
Evaluable Population
Posted
Number
95% Confidence Interval
Percentage of Participants
First 8 Weeks of Treatment
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Primary
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I
Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) & disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.
Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.
PRO Skindex Analysis Population: participants that met primary endpoint analysis & Skindex specific criteria: a) Skindex completion criteria (as above) for initial visit & end of Cycle 2 or EoT visit; b) Skindex completion criteria for at least 5 of 6 visits between initial visit & end of Cycle 2 visit. n = number of participants completing scale.
Posted
Mean
Standard Deviation
Score on a scale
First 8 Weeks of Treatment
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
Primary
Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II
Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.
95% CI calculated using exact method based on binomial distribution.
Evaluable Population
Posted
Number
95% Confidence Interval
Percentage of Participants
First 8 Weeks of Treatment
ID
Title
Description
OG000
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Units
Counts
Participants
OG000
Primary
Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II
Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.
Modified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).
M/T = mouth and throat.
PRO Modified OMDQ Analysis Population; participants meeting primary endpoint analysis & modified OMDQ specific criteria: a) Modified OMDQ completion criteria for initial visit & end of Cycle 2 or EoT visit; b) Completion criteria for at least 5 of 6 visits between initial & end of Cycle 2 visit. n = number of participants completing scale.
Posted
Mean
Standard Deviation
Score on a scale
Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up
ID
Title
Description
OG000
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Primary
Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II
SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.
95% CI calculated using exact method based on binomial distribution.
Evaluable Population
Posted
Number
95% Confidence Interval
Percentage of Participants
First 8 Weeks of Treatment
ID
Title
Description
OG000
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Units
Counts
Participants
Primary
Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II
SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.
95% CI calculated using exact method based on binomial distribution.
Evaluable Population
Posted
Number
95% Confidence Interval
Percentage of Participants
First 8 Weeks of Treatment
ID
Title
Description
OG000
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Units
Counts
Participants
Primary
Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II
PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses "bother". It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if > 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.
Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit.
PRO Skindex Analysis Population
Posted
Mean
Standard Deviation
Score on a scale
Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up
ID
Title
Description
OG000
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Secondary
Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III
Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).
As Treated Population
Posted
Number
Percentage of Participants
Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
Primary
Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.
ng*hr/mL = nanogram hours per milliliter
Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
ID
Title
Description
OG000
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Units
Counts
Participants
Primary
Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter
Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
ID
Title
Description
OG000
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Units
Counts
Participants
OG000
Primary
Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III
Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.
Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.
Posted
Median
Full Range
hours (hr)
Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).
ID
Title
Description
OG000
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Units
Counts
Participants
OG000
Secondary
Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.
Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.
Number of participants analyzed is the number of participants contributing to the summary statistics.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
Secondary
Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
Cmax was obtained from direct inspection of the data.
Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.
Number of participants analyzed is the number of participants contributing to the summary statistics.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Secondary
Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I
Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.
Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.
Number of participants analyzed is the number of participants contributing to the summary statistics.
Posted
Median
Full Range
hr
Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Secondary
Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I
CL/F was calculated as dose/AUCtau.
Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.
Number of participants analyzed is the number of participants contributing to the summary statistics.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour
Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Secondary
Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III
Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.
Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.
Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
Secondary
Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III
Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.
Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics.
Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.
ID
Title
Description
OG000
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
Time Frame
Reported AEs and serious AEs (SAEs) included events starting from the time participant had taken at least 1 dose of study drug through and including 28 calendar days after the last dose of study drug, with a median of 12 weeks.
Description
The same event may appear as both an AE & SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant & non-serious in another, or 1 participant may have experienced both a serious & non-serious event during the study. Summaries inclusive of events occurring after start of 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
Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
25
66
65
66
EG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
27
66
66
66
EG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
3
7
7
7
EG003
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
22
67
64
67
EG004
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
6
25
25
25
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG0031 affected67 at risk
EG0041 affected25 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Diplopia
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0012 affected66 at risk
EG0021 affected7 at risk
EG003
Duodenal ulcer perforation
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0013 affected66 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Chest pain
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Disease progression
General disorders
MedDRA version 18.0
Systematic Assessment
EG0007 affected66 at risk
EG0017 affected66 at risk
EG0020 affected7 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Pain
General disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Septic shock
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0013 affected66 at risk
EG0020 affected7 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Non-small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Aphasia
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0012 affected66 at risk
EG0021 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Perivascular dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Embolism
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG00010 affected66 at risk
EG0017 affected66 at risk
EG0023 affected7 at risk
EG0035 affected67 at risk
EG0043 affected25 at risk
Tachycardia
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Dry eye
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Eye pain
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0022 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0007 affected66 at risk
EG0017 affected66 at risk
EG0020 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0013 affected66 at risk
EG0020 affected7 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0009 affected66 at risk
EG00114 affected66 at risk
EG0022 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG00054 affected66 at risk
EG00152 affected66 at risk
EG0027 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0015 affected66 at risk
EG0021 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG00110 affected66 at risk
EG0020 affected7 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG00028 affected66 at risk
EG00131 affected66 at risk
EG0022 affected7 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Oral mucosal erythema
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG00010 affected66 at risk
EG00112 affected66 at risk
EG0023 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG00016 affected66 at risk
EG00123 affected66 at risk
EG0023 affected7 at risk
EG003
Asthenia
General disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0017 affected66 at risk
EG0022 affected7 at risk
EG003
Chest discomfort
General disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Chills
General disorders
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0010 affected66 at risk
EG0024 affected7 at risk
EG003
Fatigue
General disorders
MedDRA version 18.0
Systematic Assessment
EG00024 affected66 at risk
EG00127 affected66 at risk
EG0023 affected7 at risk
EG003
Influenza like illness
General disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Malaise
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0012 affected66 at risk
EG0021 affected7 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 18.0
Systematic Assessment
EG00019 affected66 at risk
EG00121 affected66 at risk
EG0022 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 18.0
Systematic Assessment
EG0006 affected66 at risk
EG0014 affected66 at risk
EG0021 affected7 at risk
EG003
Pain
General disorders
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0017 affected66 at risk
EG0021 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0014 affected66 at risk
EG0021 affected7 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Immunosuppression
Immune system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Cystitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Folliculitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0022 affected7 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Otitis externa
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Paronychia
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG00012 affected66 at risk
EG00110 affected66 at risk
EG0023 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0012 affected66 at risk
EG0021 affected7 at risk
EG003
Rash pustular
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0008 affected66 at risk
EG0017 affected66 at risk
EG0021 affected7 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0012 affected66 at risk
EG0021 affected7 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0010 affected66 at risk
EG0022 affected7 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0006 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0008 affected66 at risk
EG0015 affected66 at risk
EG0021 affected7 at risk
EG003
Transaminases increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA version 18.0
Systematic Assessment
EG00015 affected66 at risk
EG00115 affected66 at risk
EG0022 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG00024 affected66 at risk
EG00122 affected66 at risk
EG0023 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG00015 affected66 at risk
EG00115 affected66 at risk
EG0021 affected7 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0008 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0009 affected66 at risk
EG00110 affected66 at risk
EG0020 affected7 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0007 affected66 at risk
EG00114 affected66 at risk
EG0021 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0017 affected66 at risk
EG0022 affected7 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0017 affected66 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0015 affected66 at risk
EG0021 affected7 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0016 affected66 at risk
EG0021 affected7 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0006 affected66 at risk
EG0012 affected66 at risk
EG0021 affected7 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0017 affected66 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0015 affected66 at risk
EG0021 affected7 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0012 affected66 at risk
EG0020 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0013 affected66 at risk
EG0021 affected7 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0019 affected66 at risk
EG0021 affected7 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0008 affected66 at risk
EG0016 affected66 at risk
EG0023 affected7 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0008 affected66 at risk
EG0019 affected66 at risk
EG0022 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG00010 affected66 at risk
EG0014 affected66 at risk
EG0021 affected7 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0016 affected66 at risk
EG0020 affected7 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0020 affected7 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0012 affected66 at risk
EG0021 affected7 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0012 affected66 at risk
EG0021 affected7 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0013 affected66 at risk
EG0020 affected7 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0007 affected66 at risk
EG0012 affected66 at risk
EG0022 affected7 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG00016 affected66 at risk
EG00112 affected66 at risk
EG0022 affected7 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG00027 affected66 at risk
EG00119 affected66 at risk
EG0022 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG00012 affected66 at risk
EG00110 affected66 at risk
EG0021 affected7 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0022 affected7 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0007 affected66 at risk
EG0015 affected66 at risk
EG0020 affected7 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0007 affected66 at risk
EG00113 affected66 at risk
EG0023 affected7 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG00028 affected66 at risk
EG00129 affected66 at risk
EG0025 affected7 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 affected66 at risk
EG0011 affected66 at risk
EG0021 affected7 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0003 affected66 at risk
EG0018 affected66 at risk
EG0021 affected7 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0014 affected66 at risk
EG0020 affected7 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0005 affected66 at risk
EG0018 affected66 at risk
EG0020 affected7 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0002 affected66 at risk
EG0016 affected66 at risk
EG0021 affected7 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0004 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Trichorrhexis
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0022 affected7 at risk
EG003
Hyperaemia
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0021 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 affected66 at risk
EG0010 affected66 at risk
EG0020 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0009 affected66 at risk
EG0013 affected66 at risk
EG0021 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D002289
Carcinoma, Non-Small-Cell Lung
Ancestor Terms
ID
Term
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C525726
dacomitinib
D004318
Doxycycline
D019936
Probiotics
Ancestor Terms
ID
Term
D013754
Tetracyclines
D009279
Naphthacenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D011083
Polycyclic Compounds
D019587
Dietary Supplements
D005502
Food
D000066888
Diet, Food, and Nutrition
D010829
Physiological Phenomena
D019602
Food and Beverages
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
0 subjects
2 subjects
2 subjects
66.0
± 9.63
BG00464.2± 14.29
BG00564.9± 10.59
2
BG00324
BG00418
BG005109
Male
BG00028
BG00139
BG0025
BG00343
BG0047
BG005122
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
Units
Counts
Participants
OG00058
OG00156
Title
Denominators
Categories
Title
Measurements
OG00046.6(33.3 to 60.1)
OG00123.2(13.0 to 36.4)
OG001
Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
OG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Units
Counts
Participants
OG00042
OG00142
OG0024
Title
Denominators
Categories
Symptoms: Cycle 1 Day 8 (n=41, 42, 4)
Title
Measurements
OG0002.3± 10.12
OG001-1.1± 10.91
OG0029.4± 14.18
Symptoms: Cycle 1 Day 15 (n=41, 42, 3)
Title
Measurements
OG00021.4± 30.98
OG0015.0± 19.82
OG00230.6± 42.56
Symptoms: Cycle 1 Day 22 (n=42, 40, 4)
Title
Measurements
OG00018.0± 25.76
OG0016.8± 20.45
OG00232.3± 25.54
Symptoms: Cycle 2 Day 1 (n=41, 42, 4)
Title
Measurements
OG00014.7± 23.74
OG0016.3± 15.38
OG00214.6± 18.48
Symptoms: Cycle 2 Day 8 (n=42, 39, 4)
Title
Measurements
OG00017.8± 26.78
OG0019.8± 20.00
OG00213.5± 19.36
Symptoms: Cycle 2 Day 15 (n=37, 40, 4)
Title
Measurements
OG00016.6± 21.10
OG0019.2± 19.54
OG00219.8± 28.74
Symptoms: Cycle 2 Day 22 (n=35, 39, 4)
Title
Measurements
OG00015.4± 22.34
OG00112.9± 22.72
OG00214.6± 15.40
Symptoms: EoT (n=7, 3, 0)
Title
Measurements
OG00013.1± 32.85
OG00116.7± 19.09
OG002NA± NANA = not applicable. The number of participants completing the scale at this timepoint was 0.
Emotion: Cycle 1 Day 8 (n=41, 42, 4)
Title
Measurements
OG0003.7± 21.08
OG001-2.5± 12.11
OG0027.3± 14.68
Emotion: Cycle 1 Day 15 (n=41, 42, 3)
Title
Measurements
OG00020.7± 28.51
OG0012.9± 17.14
OG00229.8± 45.03
Emotion: Cycle 1 Day 22 (n=42, 40, 4)
Title
Measurements
OG00017.7± 27.67
OG0013.7± 16.07
OG00237.7± 32.44
Emotion: Cycle 2 Day 1 (n=41, 42, 4)
Title
Measurements
OG00015.6± 25.15
OG0016.5± 15.25
OG00223.4± 30.15
Emotion: Cycle 2 Day 8 (n=42, 39, 4)
Title
Measurements
OG00015.1± 25.55
OG0016.3± 17.28
OG00221.6± 35.76
Emotion: Cycle 2 Day 15 (n=37, 40, 4)
Title
Measurements
OG00013.0± 22.70
OG0018.4± 20.20
OG00221.0± 40.49
Emotion: Cycle 2 Day 22 (n=35, 39, 4)
Title
Measurements
OG00014.8± 25.91
OG00112.0± 23.73
OG00210.9± 17.39
Emotion: EoT (n=7, 3, 0)
Title
Measurements
OG0009.9± 21.27
OG00122.2± 21.34
OG002NA± NAThe number of participants completing the scale at this timepoint was 0.
Functioning: Cycle 1 Day 8 (n=41, 42, 4)
Title
Measurements
OG0003.1± 17.60
OG001-1.2± 5.50
OG002-0.8± 1.67
Functioning: Cycle 1 Day 15 (n=41, 42, 3)
Title
Measurements
OG00011.1± 21.41
OG0010.6± 7.47
OG00224.4± 42.34
Functioning: Cycle 1 Day 22 (n=42, 40, 4)
Title
Measurements
OG00011.7± 21.68
OG0011.9± 8.86
OG00233.3± 31.39
Functioning: Cycle 2 Day 1 (n=41, 42, 4)
Title
Measurements
OG0008.5± 21.53
OG0012.1± 7.72
OG00220.0± 21.26
Functioning: Cycle 2 Day 8 (n=42, 39, 4)
Title
Measurements
OG0007.0± 18.51
OG0012.4± 9.52
OG00212.5± 20.79
Functioning: Cycle 2 Day 15 (n=37, 40, 4)
Title
Measurements
OG0008.3± 22.20
OG0012.7± 10.58
OG00213.3± 22.44
Functioning: Cycle 2 Day 22 (n=35, 39, 4)
Title
Measurements
OG0007.8± 22.32
OG0015.4± 13.78
OG00214.2± 20.44
Functioning: EoT (n=7, 3, 0)
Title
Measurements
OG0008.6± 11.84
OG00114.4± 25.02
OG002NA± NAThe number of participants completing the scale at this timepoint was 0.
Total: Cycle 1 Day 8 (n=41, 42, 4)
Title
Measurements
OG0003.2± 15.91
OG001-1.7± 8.07
OG0025.3± 9.36
Total: Cycle 1 Day 15 (n=41, 42, 3)
Title
Measurements
OG00017.9± 25.09
OG0012.7± 13.08
OG00228.4± 43.52
Total: Cycle 1 Day 22 (n=42, 40, 4)
Title
Measurements
OG00015.9± 23.39
OG0014.0± 13.33
OG00235.0± 29.97
Total: Cycle 2 Day 1 (n=41, 42, 4)
Title
Measurements
OG00013.1± 20.74
OG0015.1± 11.65
OG00220.2± 21.75
Total: Cycle 2 Day 8 (n=42, 39, 4)
Title
Measurements
OG00013.2± 21.17
OG0016.0± 13.49
OG00216.8± 24.54
Total: Cycle 2 Day 15 (n=37, 40, 4)
Title
Measurements
OG00012.4± 20.39
OG0016.8± 14.84
OG00218.4± 31.50
Total: Cycle 2 Day 22 (n=35, 39, 4)
Title
Measurements
OG00012.7± 21.24
OG00110.1± 18.36
OG00212.9± 17.22
Total: EoT (n=7, 3, 0)
Title
Measurements
OG00010.3± 18.79
OG00118.4± 18.64
OG002NA± NAThe number of participants completing the scale at this timepoint was 0.
59
Title
Denominators
Categories
All Causality, All Grade
Title
Measurements
OG00083.1(71.0 to 91.6)
All Causality, Grade ≥2
Title
Measurements
OG00039.0(26.5 to 52.6)
Units
Counts
Participants
OG00037
Title
Denominators
Categories
M/T Soreness Categories: Cycle 1 Day 8 (n=37)
Title
Measurements
OG0000.8± 2.05
M/T Soreness Categories: Cycle 1 Day 15 (n=37)
Title
Measurements
OG0002.5± 3.12
M/T Soreness Categories: Cycle 1 Day 22 (n=37)
Title
Measurements
OG0002.6± 2.97
M/T Soreness Categories: Cycle 2 Day 1 (n=37)
Title
Measurements
OG0002.5± 2.43
M/T Soreness Categories: Cycle 2 Day 8 (n=35)
Title
Measurements
OG0001.9± 2.30
M/T Soreness Categories: Cycle 2 Day 15 (n=36)
Title
Measurements
OG0001.7± 1.97
M/T Soreness Categories: Cycle 2 Day 22 (n=27)
Title
Measurements
OG0001.6± 1.85
M/T Soreness Categories: Cycle 3 Day 1 (n=19)
Title
Measurements
OG0002.1± 2.09
M/T Soreness Categories: Cycle 4 Day 1 (n=13)
Title
Measurements
OG0001.7± 2.14
M/T Soreness Categories: Cycle 5 Day 1 (n=10)
Title
Measurements
OG0001.0± 1.29
M/T Soreness Categories: Cycle 6 Day 1 (n=8)
Title
Measurements
OG0000.3± 0.88
M/T Soreness Categories: EoT (n=30)
Title
Measurements
OG0001.4± 2.34
M/T Soreness Categories: Follow-up (n=22)
Title
Measurements
OG0000.3± 2.48
M/T Soreness Scale: Cycle 1 Day 8 (n=37)
Title
Measurements
OG0001.0± 2.00
M/T Soreness Scale: Cycle 1 Day 15 (n=37)
Title
Measurements
OG0002.5± 3.00
M/T Soreness Scale: Cycle 1 Day 22 (n=37)
Title
Measurements
OG0002.2± 2.51
M/T Soreness Scale: Cycle 2 Day 1 (n=37)
Title
Measurements
OG0002.2± 2.28
M/T Soreness Scale: Cycle 2 Day 8 (n=35)
Title
Measurements
OG0001.7± 1.97
M/T Soreness Scale: Cycle 2 Day 15 (n=36)
Title
Measurements
OG0001.6± 1.83
M/T Soreness Scale: Cycle 2 Day 22 (n=27)
Title
Measurements
OG0001.9± 2.45
M/T Soreness Scale: Cycle 3 Day 1 (n=19)
Title
Measurements
OG0002.2± 2.81
M/T Soreness Scale: Cycle 4 Day 1 (n=13)
Title
Measurements
OG0001.6± 2.81
M/T Soreness Scale: Cycle 5 Day 1 (n=10)
Title
Measurements
OG0001.0± 1.76
M/T Soreness Scale: Cycle 6 Day 1 (n=8)
Title
Measurements
OG0000.1± 0.35
M/T Soreness Scale: EoT (n=30)
Title
Measurements
OG0001.3± 1.78
M/T Soreness Scale: Follow-up (n=22)
Title
Measurements
OG0000.5± 1.68
Diarrhea Categories: Cycle 1 Day 8 (n=37)
Title
Measurements
OG0002.1± 2.67
Diarrhea Categories: Cycle 1 Day 15 (n=37)
Title
Measurements
OG0003.2± 2.94
Diarrhea Categories: Cycle 1 Day 22 (n=36)
Title
Measurements
OG0003.9± 3.19
Diarrhea Categories: Cycle 2 Day 1 (n=37)
Title
Measurements
OG0003.0± 2.83
Diarrhea Categories: Cycle 2 Day 8 (n=34)
Title
Measurements
OG0002.2± 3.00
Diarrhea Categories: Cycle 2 Day 15 (n=36)
Title
Measurements
OG0002.1± 3.13
Diarrhea Categories: Cycle 2 Day 22 (n=27)
Title
Measurements
OG0002.7± 3.10
Diarrhea Categories: Cycle 3 Day 1 (n=19)
Title
Measurements
OG0002.8± 2.75
Diarrhea Categories: Cycle 4 Day 1 (n=13)
Title
Measurements
OG0002.3± 3.14
Diarrhea Categories: Cycle 5 Day 1 (n=10)
Title
Measurements
OG0003.8± 3.39
Diarrhea Categories: Cycle 6 Day 1 (n=8)
Title
Measurements
OG0001.9± 2.22
Diarrhea Categories: EoT (n=30)
Title
Measurements
OG0001.9± 3.39
Diarrhea Categories: Follow-up (n=22)
Title
Measurements
OG000-0.1± 0.94
Diarrhea Scale: Cycle 1 Day 8 (n=37)
Title
Measurements
OG0001.2± 1.89
Diarrhea Scale: Cycle 1 Day 15 (n=37)
Title
Measurements
OG0002.4± 2.55
Diarrhea Scale: Cycle 1 Day 22 (n=36)
Title
Measurements
OG0003.0± 2.96
Diarrhea Scale: Cycle 2 Day 1 (n=37)
Title
Measurements
OG0002.5± 2.61
Diarrhea Scale: Cycle 2 Day 8 (n=34)
Title
Measurements
OG0002.0± 2.75
Diarrhea Scale: Cycle 2 Day 15 (n=35)
Title
Measurements
OG0001.7± 2.71
Diarrhea Scale: Cycle 2 Day 22 (n=27)
Title
Measurements
OG0002.0± 2.16
Diarrhea Scale: Cycle 3 Day 1 (n=19)
Title
Measurements
OG0002.4± 2.34
Diarrhea Scale: Cycle 4 Day 1 (n=13)
Title
Measurements
OG0001.8± 2.13
Diarrhea Scale: Cycle 5 Day 1 (n=10)
Title
Measurements
OG0002.7± 2.31
Diarrhea Scale: Cycle 6 Day 1 (n=8)
Title
Measurements
OG0001.5± 1.93
Diarrhea Scale: EoT (n=30)
Title
Measurements
OG0001.6± 2.87
Diarrhea Scale: Follow-up (n=22)
Title
Measurements
OG000-0.1± 0.71
OG00059
Title
Denominators
Categories
Title
Measurements
OG00079.7(67.2 to 89.0)
OG00059
Title
Denominators
Categories
Title
Measurements
OG00035.6(23.6 to 49.1)
Units
Counts
Participants
OG00040
Title
Denominators
Categories
Symptoms: Cycle 1 Day 8 (n=40)
Title
Measurements
OG0000.1± 8.31
Symptoms: Cycle 1 Day 15 (n=40)
Title
Measurements
OG00011.4± 21.25
Symptoms: Cycle 1 Day 22 (n=40)
Title
Measurements
OG00011.4± 18.17
Symptoms: Cycle 2 Day 1 (n=40)
Title
Measurements
OG00011.4± 19.84
Symptoms: Cycle 2 Day 8 (n=38)
Title
Measurements
OG00013.5± 20.88
Symptoms: Cycle 2 Day 15 (n=38)
Title
Measurements
OG00014.7± 17.83
Symptoms: Cycle 2 Day 22 (n=30)
Title
Measurements
OG00013.6± 16.30
Symptoms: Cycle 3 Day 1 (n=21)
Title
Measurements
OG00012.7± 19.56
Symptoms: Cycle 4 Day 1 (n=15)
Title
Measurements
OG00011.9± 18.69
Symptoms: Cycle 5 Day 1 (n=11)
Title
Measurements
OG0008.0± 22.24
Symptoms: Cycle 6 Day 1 (n=8)
Title
Measurements
OG00012.0± 32.15
Symptoms: EoT (n=33)
Title
Measurements
OG00010.4± 21.33
Symptoms: Follow-up (n=23)
Title
Measurements
OG0007.1± 23.15
Emotion: Cycle 1 Day 8 (n=40)
Title
Measurements
OG0001.0± 11.79
Emotion: Cycle 1 Day 15 (n=40)
Title
Measurements
OG0008.7± 23.57
Emotion: Cycle 1 Day 22 (n=40)
Title
Measurements
OG00012.3± 24.63
Emotion: Cycle 2 Day 1 (n=40)
Title
Measurements
OG00010.2± 21.36
Emotion: Cycle 2 Day 8 (n=38)
Title
Measurements
OG00010.3± 21.77
Emotion: Cycle 2 Day 15 (n=37)
Title
Measurements
OG00013.5± 17.10
Emotion: Cycle 2 Day 22 (n= 30)
Title
Measurements
OG00012.6± 19.86
Emotion: Cycle 3 Day 1 (n=21)
Title
Measurements
OG00011.0± 17.97
Emotion: Cycle 4 Day 1 (n=14)
Title
Measurements
OG00011.5± 14.65
Emotion: Cycle 5 Day 1 (n=11)
Title
Measurements
OG0007.8± 21.43
Emotion: Cycle 6 Day 1 (n=8)
Title
Measurements
OG0006.8± 22.67
Emotion: EoT (n=33)
Title
Measurements
OG0008.5± 23.38
Emotion: Follow-up (n=23)
Title
Measurements
OG0007.1± 22.74
Functioning: Cycle 1 Day 8 (n=40)
Title
Measurements
OG0000.5± 3.58
Functioning: Cycle 1 Day 15 (n=40)
Title
Measurements
OG0004.3± 13.34
Functioning: Cycle 1 Day 22 (n=40)
Title
Measurements
OG0008.8± 17.55
Functioning: Cycle 2 Day 1 (n=40)
Title
Measurements
OG0007.3± 15.25
Functioning: Cycle 2 Day 8 (n=38)
Title
Measurements
OG0006.2± 15.33
Functioning: Cycle 2 Day 15 (n=38)
Title
Measurements
OG0007.0± 11.75
Functioning: Cycle 2 Day 22 (n=30)
Title
Measurements
OG0007.2± 10.06
Functioning: Cycle 3 Day 1 (n=21)
Title
Measurements
OG0005.9± 8.09
Functioning: Cycle 4 Day 1 (n=15)
Title
Measurements
OG0006.9± 10.12
Functioning: Cycle 5 Day 1 (n=11)
Title
Measurements
OG0005.5± 12.93
Functioning: Cycle 6 Day 1 (n=8)
Title
Measurements
OG0007.1± 15.58
Functioning: EoT (n=33)
Title
Measurements
OG0007.7± 17.35
Functioning: Follow-up (n=23)
Title
Measurements
OG0005.4± 18.55
Total: Cycle 1 Day 8 (n=40)
Title
Measurements
OG0000.6± 6.83
Total: Cycle 1 Day 15 (n=40)
Title
Measurements
OG0008.0± 18.73
Total: Cycle 1 Day 22 (n=40)
Title
Measurements
OG00011.0± 19.59
Total: Cycle 2 Day 1 (n=40)
Title
Measurements
OG0009.6± 17.38
Total: Cycle 2 Day 8 (n=38)
Title
Measurements
OG0009.9± 17.79
Total: Cycle 2 Day 15 (n=38)
Title
Measurements
OG00011.8± 14.13
Total: Cycle 2 Day 22 (n=30)
Title
Measurements
OG00011.2± 14.14
Total: Cycle 3 Day 1 (n=21)
Title
Measurements
OG0009.8± 14.11
Total: Cycle 4 Day 1 (n=15)
Title
Measurements
OG00010.2± 12.49
Total: Cycle 5 Day 1 (n=11)
Title
Measurements
OG0007.1± 18.60
Total: Cycle 6 Day 1 (n=8)
Title
Measurements
OG0008.2± 22.43
Total: EoT (n=33)
Title
Measurements
OG0008.7± 19.74
Total: Follow-up (n=23)
Title
Measurements
OG0006.6± 20.52
OG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
OG003
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
OG004
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Units
Counts
Participants
OG00066
OG00166
OG0027
OG00367
OG00425
Title
Denominators
Categories
Any Concomitant Drug
Title
Measurements
OG00069.7
OG00160.6
OG00285.7
OG00382.1
OG00488.0
Any Non-Drug Treatment
Title
Measurements
OG00016.7
OG00116.7
OG00242.9
OG003
OG00023
Title
Denominators
Categories
Dacomitinib AUC0-24
Title
Measurements
OG0001712.88± 35
Dacomitinib AUC0-120
Title
Measurements
OG0005743.60± 32
PF-05199265 AUC0-24
Title
Measurements
OG000184.62± 139
PF-05199265 AUC0-120
Title
Measurements
OG000742.32± 129
23
Title
Denominators
Categories
Dacomitinib Cmax
Title
Measurements
OG00079.68± 36
PF-05199265 Cmax
Title
Measurements
OG0008.5176± 137
23
Title
Denominators
Categories
Dacomitinib Tmax
Title
Measurements
OG0005.850± 53(0 to 24.30)
PF-05199265 Tmax
Title
Measurements
OG0005.980± 126(0 to 24.30)
OG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Units
Counts
Participants
OG00027
OG00127
OG0022
Title
Denominators
Categories
Dacomitinib AUC0-tau
Title
Measurements
OG0001801.96± 59
OG0011869.23± 37
OG0021412.42± 63
PF-05199265 AUC0-tau
Title
Measurements
OG000164.520± 89
OG001112.306± 139
OG002366.933± 107
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Units
Counts
Participants
OG00031
OG00127
OG0023
Title
Denominators
Categories
Dacomitinib Cmax
Title
Measurements
OG00088.15± 57
OG00189.79± 36
OG00298.08± 89
PF-05199265 Cmax
Title
Measurements
OG0007.7426± 80
OG0015.2901± 141
OG0028.8545± 260
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Units
Counts
Participants
OG00031
OG00127
OG0023
Title
Denominators
Categories
Dacomitinib Tmax
Title
Measurements
OG0004.000± 67(0 to 24.00)
OG0016.000± 67(0 to 24.30)
OG0026.580± 108(4.02 to 22.20)
PF-05199265 Tmax
Title
Measurements
OG0004.050± 82(0 to 24.10)
OG0014.020± 125(0 to 24.30)
OG0026.580± 105(0 to 22.20)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Units
Counts
Participants
OG00031
OG00127
OG0023
Title
Denominators
Categories
Title
Measurements
OG00029.94± 85
OG00124.07± 37
OG00234.24± 45
OG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
OG003
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
OG004
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Units
Counts
Participants
OG00034
OG00132
OG0025
OG00315
OG00423
Title
Denominators
Categories
Cycle 3 Day 1 (n=13, 15, 3, 14, 15)
Title
Measurements
OG00065.477± 50
OG00165.063± 55
OG00256.212± 46
OG00366.338± 58
OG00455.780± 40
Cycle 4 Day 1 (n=8, 7, 2, 5, 13)
Title
Measurements
OG00061.592± 36
OG00167.109± 29
OG00265.466± 49
OG003
Cycle 5 Day 1 (n=3, 6, 2, 3, 12)
Title
Measurements
OG00089.970± 38
OG00168.012± 39
OG00269.649± 63
OG003
Cycle 6 Day 1 (n=2, 5, 1, 2, 10)
Title
Measurements
OG00015.578± 1208
OG00172.856± 47
OG00246.000± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
Cycle 7 Day 1 (n=2, 1, 1, 1, 8)
Title
Measurements
OG00059.086± 47
OG00140.900± NAGeometric mean coefficient of variation is not calculable as n=1.
OG00259.900± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
Cycle 8 Day 1 (n=2, 2, 1, 2, 8)
Title
Measurements
OG00061.430± 90
OG00158.988± 31
OG00247.00± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
Cycle 9 Day 1 (n=2, 2, 1, 2, 6)
Title
Measurements
OG00064.747± 72
OG00158.928± 31
OG00246.000± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
Cycle 10 Day 1 (n=1, 2, 1, 2, 4)
Title
Measurements
OG00051.400± NAGeometric mean coefficient of variation is not calculable as n=1.
OG00154.041± 48
OG00258.800± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
OG002
Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
OG003
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
OG004
Cohort III (Dacomitinib 45 mg)
Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
Units
Counts
Participants
OG00034
OG00132
OG0025
OG00315
OG00423
Title
Denominators
Categories
Cycle 3 Day 1 (n=13, 15, 3, 14, 15)
Title
Measurements
OG0006.988± 60
OG0014.653± 133
OG00210.220± 11
OG0037.814± 59
OG0049.967± 149
Cycle 4 Day 1 (n=8, 7, 2, 5, 13)
Title
Measurements
OG0005.555± 71
OG0015.271± 242
OG0028.522± 15
OG003
Cycle 5 Day 1 (n=3, 6, 2, 3, 12)
Title
Measurements
OG0004.356± 55
OG0014.989± 58
OG0028.522± 10
OG003
Cycle 6 Day 1 (n=2, 5, 1, 2, 10)
Title
Measurements
OG0005.020± 70
OG0016.523± 123
OG0028.150± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
Cycle 7 Day 1 (n=2, 1, 1, 1, 8)
Title
Measurements
OG0004.850± 49
OG00123.900± NAGeometric mean coefficient of variation is not calculable as n=1.
OG0028.560± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
Cycle 8 Day 1 (n=2, 2, 1, 2, 8)
Title
Measurements
OG0005.349± 54
OG0016.085± 476
OG00210.100± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
Cycle 9 Day 1 (n=2, 2, 1, 2, 6)
Title
Measurements
OG0004.271± 34
OG0016.448± 612
OG0029.720± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
Cycle 10 Day 1 (n=1, 2, 1, 2, 4)
Title
Measurements
OG0003.460± NAGeometric mean coefficient of variation is not calculable as n=1.
OG0016.892± 305
OG00210.700± NAGeometric mean coefficient of variation is not calculable as n=1.
OG003
0 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
2 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
8 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
5 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
3 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
2 affected
67 at risk
EG0043 affected25 at risk
0 affected
67 at risk
EG0042 affected25 at risk
1 affected
67 at risk
EG0042 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
2 affected
67 at risk
EG0042 affected25 at risk
3 affected
67 at risk
EG0043 affected25 at risk
2 affected
67 at risk
EG0042 affected25 at risk
3 affected
67 at risk
EG0041 affected25 at risk
8 affected
67 at risk
EG0043 affected25 at risk
54 affected
67 at risk
EG00423 affected25 at risk
4 affected
67 at risk
EG0046 affected25 at risk
2 affected
67 at risk
EG0043 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0042 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
20 affected
67 at risk
EG0044 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
7 affected
67 at risk
EG0042 affected25 at risk
14 affected
67 at risk
EG00416 affected25 at risk
14 affected
67 at risk
EG0045 affected25 at risk
3 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0042 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
20 affected
67 at risk
EG0045 affected25 at risk
0 affected
67 at risk
EG0044 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
12 affected
67 at risk
EG0045 affected25 at risk
4 affected
67 at risk
EG0043 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0044 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0042 affected25 at risk
0 affected
67 at risk
EG0042 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
4 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0042 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
9 affected
67 at risk
EG00416 affected25 at risk
2 affected
67 at risk
EG0042 affected25 at risk
7 affected
67 at risk
EG0042 affected25 at risk
3 affected
67 at risk
EG0047 affected25 at risk
2 affected
67 at risk
EG0043 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0042 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
2 affected
67 at risk
EG0043 affected25 at risk
3 affected
67 at risk
EG0043 affected25 at risk
4 affected
67 at risk
EG0041 affected25 at risk
3 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
8 affected
67 at risk
EG0047 affected25 at risk
25 affected
67 at risk
EG00414 affected25 at risk
9 affected
67 at risk
EG0041 affected25 at risk
2 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
2 affected
67 at risk
EG0042 affected25 at risk
10 affected
67 at risk
EG0042 affected25 at risk
8 affected
67 at risk
EG0041 affected25 at risk
2 affected
67 at risk
EG0042 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
4 affected
67 at risk
EG0040 affected25 at risk
6 affected
67 at risk
EG0043 affected25 at risk
0 affected
67 at risk
EG0042 affected25 at risk
1 affected
67 at risk
EG0042 affected25 at risk
5 affected
67 at risk
EG0041 affected25 at risk
6 affected
67 at risk
EG0046 affected25 at risk
0 affected
67 at risk
EG0045 affected25 at risk
1 affected
67 at risk
EG0042 affected25 at risk
2 affected
67 at risk
EG0044 affected25 at risk
7 affected
67 at risk
EG0042 affected25 at risk
1 affected
67 at risk
EG0045 affected25 at risk
0 affected
67 at risk
EG0044 affected25 at risk
3 affected
67 at risk
EG0041 affected25 at risk
2 affected
67 at risk
EG0042 affected25 at risk
3 affected
67 at risk
EG0044 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
5 affected
67 at risk
EG0043 affected25 at risk
3 affected
67 at risk
EG0041 affected25 at risk
0 affected
67 at risk
EG0041 affected25 at risk
1 affected
67 at risk
EG0043 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
7 affected
67 at risk
EG0048 affected25 at risk
3 affected
67 at risk
EG0042 affected25 at risk
8 affected
67 at risk
EG0044 affected25 at risk
6 affected
67 at risk
EG0047 affected25 at risk
3 affected
67 at risk
EG0042 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0045 affected25 at risk
2 affected
67 at risk
EG0042 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
2 affected
67 at risk
EG0047 affected25 at risk
2 affected
67 at risk
EG0047 affected25 at risk
3 affected
67 at risk
EG0044 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
3 affected
67 at risk
EG0044 affected25 at risk
20 affected
67 at risk
EG00418 affected25 at risk
15 affected
67 at risk
EG00414 affected25 at risk
7 affected
67 at risk
EG0043 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
1 affected
67 at risk
EG0040 affected25 at risk
4 affected
67 at risk
EG0046 affected25 at risk
2 affected
67 at risk
EG0041 affected25 at risk
13 affected
67 at risk
EG00417 affected25 at risk
2 affected
67 at risk
EG0040 affected25 at risk
25 affected
67 at risk
EG0045 affected25 at risk
1 affected
67 at risk
EG0041 affected25 at risk
8 affected
67 at risk
EG0047 affected25 at risk
0 affected
67 at risk
EG0042 affected25 at risk
5 affected
67 at risk
EG0040 affected25 at risk
9 affected
67 at risk
EG0045 affected25 at risk
2 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0040 affected25 at risk
0 affected
67 at risk
EG0042 affected25 at risk
4 affected
67 at risk
EG0040 affected25 at risk
20.9
OG00444.0
71.116
± 49
OG00455.644± 42
66.082
± 33
OG00453.116± 44
9.201
± 3760
OG00452.603± 52
42.600
± NA
Geometric mean coefficient of variation is not calculable as n=1.
OG00455.685± 21
64.296
± 35
OG00451.559± 24
64.115
± 30
OG00444.865± 50
71.695
± 26
OG00455.362± 32
6.848
± 82
OG00411.759± 113
5.850
± 115
OG00410.510± 124
1.261
± 937
OG0047.844± 125
6.680
± NA
Geometric mean coefficient of variation is not calculable as n=1.