Afatinib and Vinorelbine in Tumours Known to Overexpress... | NCT00906698 | Trialant
NCT00906698
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jun 9, 2014Estimated
Enrollment
55Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
BIBW 2992 low (20mg) dosage
BIBW 2992 medium (40mg) dosage
BIBW 2992 high (50mg) dosage
Vinorelbine per os 60 mg/m²
Vinorelbine per os 80 mg/m²
Vinorelbine i.v. 25 mg/m²
Countries
France
Protocol Section
Identification Module
NCT ID
NCT00906698
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1200.69
Secondary IDs
ID
Type
Description
Link
2008-006290-32
EudraCT Number
EudraCT
Brief Title
Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2
Official Title
Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Mar 2014
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
Jun 2009
Primary Completion Date
Jan 2013Actual
Completion Date
Jan 2013Actual
First Submitted Date
May 14, 2009
First Submission Date that Met QC Criteria
May 20, 2009
First Posted Date
May 21, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 10, 2014
Results First Submitted that Met QC Criteria
Mar 21, 2014
Results First Posted Date
Apr 17, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 3, 2014
Last Update Posted Date
Jun 9, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
55Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BIBW 2992 and vinorelbine i.v
Experimental
Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine i.v.
Drug: BIBW 2992 low (20mg) dosage
Drug: BIBW 2992 medium (40mg) dosage
Drug: BIBW 2992 high (50mg) dosage
Drug: Vinorelbine i.v. 25 mg/m²
BIBW 2992 and vinorelbine per os
Experimental
Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine per os.
Drug: BIBW 2992 low (20mg) dosage
Drug: BIBW 2992 medium (40mg) dosage
Drug: BIBW 2992 high (50mg) dosage
Drug: Vinorelbine per os 60 mg/m²
Drug: Vinorelbine per os 80 mg/m²
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BIBW 2992 low (20mg) dosage
Drug
Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.
BIBW 2992 and vinorelbine i.v
BIBW 2992 and vinorelbine per os
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-limiting Toxicities (DLT)
Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD). 3+3 dose escalation design. MTD based on DLTs during first treatment course. After MTD was determined, additional patients were included at the MTD in an expansion cohort.
28 days
Secondary Outcomes
Measure
Description
Time Frame
Number of Patients With Best Overall Response
Overall response is defined as complete response, partial response and stable disease and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). Complete response (CR) and partial response (PR) had to be confirmed by a subsequent tumour assessment at least 28 days after the criteria for CR or PR were first met. To confirm a status of stable disease, the duration of stable disease was to be at least 42 days.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Histologically or cytologically confirmed diagnosis of malignancy that is now advanced, non resectable and/or metastatic
Tumours historically known to overexpress EGFR and/or HER2
Exclusion criteria:
Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start of therapy or concomitantly with this trial.
Prior treatment with EGFR inhibiting drugs within the past two weeks before the start of therapy or concomitantly with this trial.
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
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1200.69.3301 Boehringer Ingelheim Investigational Site
Toulouse
France
1200.69.3302 Boehringer Ingelheim Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
BIBW 2992 medium (40mg) dosage
Drug
Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.
BIBW 2992 and vinorelbine i.v
BIBW 2992 and vinorelbine per os
BIBW 2992 high (50mg) dosage
Drug
Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.
BIBW 2992 and vinorelbine i.v
BIBW 2992 and vinorelbine per os
Vinorelbine per os 60 mg/m²
Drug
Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15
BIBW 2992 and vinorelbine per os
Vinorelbine per os 80 mg/m²
Drug
Patients will receive 80 mg/m² Vinorelbine per os at J22
BIBW 2992 and vinorelbine per os
Vinorelbine i.v. 25 mg/m²
Drug
Patients will receive 25 mg/m² of Vinorelbine i.v.
BIBW 2992 and vinorelbine i.v
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Number of Patients With Objective Response (OR)
OR is defined as confirmed complete response and confirmed partial response (PR) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Number of Patients With Disease Control (DC)
DC is defined as confirmed complete response (CR), partial response (PR) and stable disease (SD) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Time to Objective Response
The time to OR was the duration from the first treatment to the time when the measurement criteria for first documented confirmed CR and/or PR were met according to RECIST 1.0 criteria.
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of Objective Response
The duration of objective response was measured from the time of first documented confirmed CR or PR to the time of progressive disease or death, whichever occured earlier.
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of Disease Control
Duration of disease control was measured from the start of study treatment to the time of progression or death, whichever occured first.
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Best Percentage Change in Tumour Size
Best percentage change in tumour size was the best percentage change in the sum of diameters of target lesions and was calculated as (minimum sum of diameters post baseline - sum of diameters at baseline)/sum of diameters at baseline. Negative values indicate a decrease, positive values an increase.
Screening and every 8 weeks after starting of treatment, up to 44 weeks.
Progression-free Survival (PFS)
PFS was defined as the time from the first dose of study medication to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0. Median time results from unstratified Kaplan-Meier estimates.
From first dose of study medication to the occurrence of progression or death whichever came first, up to 44 months.
Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h,, 7h and 24h after dosing
Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing
Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing
Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing
Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing
Villejuif
France
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
FG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
FG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
FG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
FG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
FG0003 subjects
FG00119 subjects
FG0026 subjects
FG0034 subjects
FG00418 subjects
FG0055 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0003 subjects
FG00119 subjects
FG0026 subjects
FG0034 subjects
FG00418 subjects
FG0055 subjects
Type
Comment
Reasons
Dose-limiting toxicity (DLT)
FG0000 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Disease progression
FG0003 subjects
FG00112 subjects
FG0024 subjects
FG0034 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
incl. non compliance, lost to follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
BG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
BG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
BG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
BG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
BG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG00119
BG0026
BG0034
BG00418
BG0055
BG00655
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
BG00059.7± 15.3
BG00155.3± 8.0
BG00261.7± 5.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG00111
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-limiting Toxicities (DLT)
Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD). 3+3 dose escalation design. MTD based on DLTs during first treatment course. After MTD was determined, additional patients were included at the MTD in an expansion cohort.
Treated Set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.
Posted
Number
participants
28 days
ID
Title
Description
OG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Units
Counts
Participants
OG0003
OG00119
OG0026
OG003
Title
Denominators
Categories
First cycle (N=3;6;6;4;6;5)
Title
Measurements
OG0000
OG0011
OG0024
OG003
Secondary
Number of Patients With Best Overall Response
Overall response is defined as complete response, partial response and stable disease and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). Complete response (CR) and partial response (PR) had to be confirmed by a subsequent tumour assessment at least 28 days after the criteria for CR or PR were first met. To confirm a status of stable disease, the duration of stable disease was to be at least 42 days.
All patients from the Treated Set (TS).
Posted
Number
participants
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
ID
Title
Description
OG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Secondary
Number of Patients With Objective Response (OR)
OR is defined as confirmed complete response and confirmed partial response (PR) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).
All patients from the Treated Set (TS).
Posted
Number
participants
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
ID
Title
Description
OG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Secondary
Number of Patients With Disease Control (DC)
DC is defined as confirmed complete response (CR), partial response (PR) and stable disease (SD) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).
All patients from the Treated Set (TS).
Posted
Number
participants
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
ID
Title
Description
OG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Secondary
Time to Objective Response
The time to OR was the duration from the first treatment to the time when the measurement criteria for first documented confirmed CR and/or PR were met according to RECIST 1.0 criteria.
Patients from the Treated Set (TS) with objective response.
Posted
Median
Full Range
days
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
ID
Title
Description
OG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Secondary
Duration of Objective Response
The duration of objective response was measured from the time of first documented confirmed CR or PR to the time of progressive disease or death, whichever occured earlier.
Patients from Treated Set (TS) with Objective Response.
Posted
Median
Full Range
days
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
ID
Title
Description
OG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Secondary
Duration of Disease Control
Duration of disease control was measured from the start of study treatment to the time of progression or death, whichever occured first.
Patients from Treated Set (TS) with disease control.
Posted
Median
Full Range
days
From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
ID
Title
Description
OG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Secondary
Best Percentage Change in Tumour Size
Best percentage change in tumour size was the best percentage change in the sum of diameters of target lesions and was calculated as (minimum sum of diameters post baseline - sum of diameters at baseline)/sum of diameters at baseline. Negative values indicate a decrease, positive values an increase.
Patients from Treated Set (TS).
Posted
Mean
Standard Error
percentage change in tumour size
Screening and every 8 weeks after starting of treatment, up to 44 weeks.
ID
Title
Description
OG000
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Secondary
Progression-free Survival (PFS)
PFS was defined as the time from the first dose of study medication to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0. Median time results from unstratified Kaplan-Meier estimates.
All patients treated in the MTD cohorts.
Posted
Median
Inter-Quartile Range
weeks
From first dose of study medication to the occurrence of progression or death whichever came first, up to 44 months.
ID
Title
Description
OG000
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG001
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Units
Counts
Secondary
Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Vinorelbine i.v.
Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
OG001
in Absence of Vinorelbine i.v.
Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
Units
Counts
Participants
OG000
Secondary
Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
All patients treated in the TS, for which evaluable PK parameters were available for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Afatinib
25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
OG001
in Absence of Afatinib
25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
Units
Counts
Participants
OG000
Secondary
Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Vinorelbine i.v.
Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
OG001
in Absence of Vinorelbine i.v.
Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
Units
Counts
Participants
OG000
Secondary
Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
All patients treated in the TS, for which evaluable PK parameters were available for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Afatinib
25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50mg Afatinib
OG001
in Absence of Afatinib
25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 and 50mg Afatinib
Units
Counts
Participants
OG000
Secondary
Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.
Posted
Median
Full Range
hours
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Vinorelbine i.v.
Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
OG001
in Absence of Vinorelbine i.v.
Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
Units
Counts
Participants
OG000
Secondary
Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
All patients treated in the TS, for which evaluable PK parameters were available for the analysis.
Posted
Median
Full Range
hours
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Afatinib
25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
OG001
in Absence of Afatinib
25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
Units
Counts
Participants
OG000
Secondary
Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State
All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h,, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Vinorelbine Per os
Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os.
OG001
in Absence of Vinorelbine Per os
Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os.
Units
Counts
Participants
OG000
Secondary
Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
All patients treated in the TS, for which evaluable PK parameters were available for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Afatinib
60 mg/m^2 vinorelbine per os in presence of Afatinib
OG001
in Absence of Afatinib
60 mg/m^2 vinorelbine per os in absence of Afatinib
Units
Counts
Participants
OG000
Secondary
Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State
All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Vinorelbine Per os
Afatinib 40 mg in presence of 25mg/m^2 vinorelbine per os
OG001
in Absence of Vinorelbine Per os
Afatinib 40 mg in absence of 25mg/m^2 vinorelbine per os
Units
Counts
Participants
OG000
Secondary
Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State
All patients treated in the TS, for which evaluable PK parameters were available for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Afatinib
60mg/m^2 vinorelbine per os in presence of afatinib
OG001
in Absence of Afatinib
60mg/m^2 vinorelbine per os in absence of afatinib
Units
Counts
Participants
OG000
Secondary
Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State
All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.
Posted
Median
Full Range
hours
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Vinorelbine Per os
Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os
OG001
in Absence of Vinorelbine Per os
Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os
Units
Counts
Participants
OG000
Secondary
Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State
All patients treated in the TS, for which evaluable PK parameters were available for the analysis.
Posted
Median
Full Range
hours
0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing
ID
Title
Description
OG000
in Presence of Afatinib
60mg/m^2 vinorelbine per os in presence of afatinib
OG001
in Absence of Afatinib
60mg/m^2 vinorelbine per os in absence of afatinib
Units
Counts
Participants
OG000
Time Frame
First administration of trial medication until 28 days after last administration of trial medication.
Description
Not provided
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
Afatinib 20mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
1
3
3
3
EG001
Afatinib 40mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
11
19
19
19
EG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
4
6
6
6
EG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
2
4
4
4
EG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
13
18
18
18
EG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
1
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG0030 affected4 at risk
EG0041 affected18 at risk
EG0050 affected5 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected19 at risk
EG0021 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Asthenia
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
General physical health deterioration
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Mucosal inflammation
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Biliary tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Lung infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Lipase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0021 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Aphasia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Convulsion
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Hemianopia homonymous
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Depression
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected19 at risk
EG0020 affected6 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0019 affected19 at risk
EG0023 affected6 at risk
EG0032 affected4 at risk
EG0048 affected18 at risk
EG0055 affected5 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0021 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected3 at risk
EG00112 affected19 at risk
EG0023 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Atrioventricular block
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Blepharitis
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Conjunctivitis
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Dry eye
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Exophthalmos
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Eyelid ptosis
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Ocular icterus
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Photopsia
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Visual acuity reduced
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected19 at risk
EG0022 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0015 affected19 at risk
EG0021 affected6 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected19 at risk
EG0021 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Chapped lips
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Cheilitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0022 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0017 affected19 at risk
EG0022 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0003 affected3 at risk
EG00119 affected19 at risk
EG0026 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected19 at risk
EG0020 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal toxicity
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Gingival pain
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Glossodynia
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected19 at risk
EG0021 affected6 at risk
EG003
Melaena
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG00112 affected19 at risk
EG0025 affected6 at risk
EG003
Odynophagia
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Oral disorder
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Portal hypertensive gastropathy
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected3 at risk
EG0017 affected19 at risk
EG0022 affected6 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0018 affected19 at risk
EG0024 affected6 at risk
EG003
Asthenia
General disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected3 at risk
EG00119 affected19 at risk
EG0026 affected6 at risk
EG003
Catheter site pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Facial pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Feeling cold
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
General physical health deterioration
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Hyperthermia
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Inflammation
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Mucosal discolouration
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Mucosal inflammation
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0018 affected19 at risk
EG0024 affected6 at risk
EG003
Oedema peripheral
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected19 at risk
EG0022 affected6 at risk
EG003
Pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Puncture site pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG00110 affected19 at risk
EG0022 affected6 at risk
EG003
Ulcer
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Xerosis
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0021 affected6 at risk
EG003
Cholestasis
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected19 at risk
EG0020 affected6 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0016 affected19 at risk
EG0021 affected6 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Cystitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Device related infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Ear infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Escherichia infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Folliculitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0017 affected19 at risk
EG0022 affected6 at risk
EG003
Fungal infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Fungal oesophagitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Fungal paronychia
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Furuncle
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Genital infection fungal
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Gingivitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Herpes virus infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Hordeolum
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Lymphangitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected19 at risk
EG0022 affected6 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Oral fungal infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Oral herpes
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Otitis externa
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Paronychia
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected19 at risk
EG0022 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Proteus infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Pulpitis dental
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Puncture site abscess
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Rash pustular
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Rhinitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0016 affected19 at risk
EG0023 affected6 at risk
EG003
Sinusitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Staphylococcal infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Tinea pedis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Tooth abscess
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Upper respiratory fungal infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0014 affected19 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Burn oesophageal
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Amylase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Blood phosphorus decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Eastern Cooperative Oncology Group performance status worsened
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected19 at risk
EG0023 affected6 at risk
EG003
White blood cell count increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Cell death
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG00113 affected19 at risk
EG0024 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected19 at risk
EG0021 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Hyperproteinaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0015 affected19 at risk
EG0023 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected19 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Hypercreatinaemia
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected19 at risk
EG0023 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected19 at risk
EG0021 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0021 affected6 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Sarcopenia
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Haemangioma of bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Aphonia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Balance disorder
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Burning sensation
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Cerebral microhaemorrhage
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Cervical root pain
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Dysaesthesia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0014 affected19 at risk
EG0022 affected6 at risk
EG003
Epilepsy
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Headache
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0021 affected6 at risk
EG003
Hydrocephalus
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Hyperaesthesia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Neuralgia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected19 at risk
EG0022 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected19 at risk
EG0025 affected6 at risk
EG003
Sciatica
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Sensory loss
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Somnolence
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0021 affected6 at risk
EG003
Toxic neuropathy
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Tremor
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0022 affected6 at risk
EG003
Depression
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Hallucination, visual
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Bladder discomfort
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0021 affected6 at risk
EG003
Micturition disorder
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Breast mass
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Breast pain
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Genital lesion
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Genital tract inflammation
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal burning sensation
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0019 affected19 at risk
EG0022 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0015 affected19 at risk
EG0021 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0019 affected19 at risk
EG0022 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0016 affected19 at risk
EG0024 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0022 affected6 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0014 affected19 at risk
EG0022 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected19 at risk
EG0021 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected19 at risk
EG0021 affected6 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Hair texture abnormal
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Nail pigmentation
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Nail pitting
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Nail toxicity
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected19 at risk
EG0020 affected6 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Pemphigoid
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected19 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0017 affected19 at risk
EG0021 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected19 at risk
EG0022 affected6 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0021 affected6 at risk
EG003
Subcutaneous nodule
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0021 affected6 at risk
EG003
Intermittent claudication
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Lymphoedema
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Pallor
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected19 at risk
EG0020 affected6 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected19 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
FG0051 subjects
12 subjects
FG0054 subjects
1 subjects
FG0050 subjects
0 subjects
FG0050 subjects
55.3
± 6.2
BG00450.9± 9.5
BG00551.0± 8.3
BG00654.4± 9.0
4
BG0030
BG00411
BG0054
BG00631
Male
BG0002
BG0018
BG0022
BG0034
BG0047
BG0051
BG00624
4
OG00418
OG0055
0
OG0041
OG0053
Expansion cohort (N=0;13;0;0;12;0)
Title
Measurements
OG000NAno expansion cohort for this arm
OG0017
OG002NAno expansion cohort for this arm
OG003NAno expansion cohort for this arm
OG0042
OG005NAno expansion cohort for this arm
OG002
Afatinib 50mg With Vinorelbine i.v.
Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Units
Counts
Participants
OG0003
OG00119
OG0026
OG0034
OG00418
OG0055
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Partial response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Stable disease
Title
Measurements
OG0001
OG00110
OG0025
OG003
Progressive disease
Title
Measurements
OG0002
OG0016
OG0020
OG003
Missing
Title
Measurements
OG0000
OG0013
OG0021
OG003
OG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Units
Counts
Participants
OG0003
OG00119
OG0026
OG0034
OG00418
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0043
OG0050
OG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Units
Counts
Participants
OG0003
OG00119
OG0026
OG0034
OG00418
OG0055
Title
Denominators
Categories
Title
Measurements
OG0001
OG00110
OG0025
OG0030
OG0049
OG0055
OG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0043
OG0050
Title
Denominators
Categories
Title
Measurements
OG00455(55 to 343)
OG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0043
OG0050
Title
Denominators
Categories
Title
Measurements
OG004114(113 to 151)
OG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
Units
Counts
Participants
OG0001
OG00110
OG0025
OG0030
OG0049
OG0055
Title
Denominators
Categories
Title
Measurements
OG000110(110 to 110)
OG001167(94 to 351)
OG002168(81 to 202)
OG004162(50 to 493)
OG005120(54 to 230)
OG003
Afatinib 20mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG004
Afatinib 40mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
OG005
Afatinib 50mg With Vinorelbine Per os
Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.