Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in... | NCT00824408 | Trialant
NCT00824408
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Sep 20, 2016Estimated
Enrollment
143Actual
Phase
Phase 2
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
pemetrexed
pemetrexed
BI 6727
Countries
Canada
The Bahamas
Protocol Section
Identification Module
NCT ID
NCT00824408
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1230.5
Secondary IDs
Not provided
Brief Title
Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC
Official Title
A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Jul 2016
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
Mar 2009
Primary Completion Date
Sep 2012Actual
Completion Date
Aug 2015Actual
First Submitted Date
Jan 15, 2009
First Submission Date that Met QC Criteria
Jan 15, 2009
First Posted Date
Jan 16, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 28, 2016
Results First Submitted that Met QC Criteria
Jul 28, 2016
Results First Posted Date
Sep 20, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 30, 2014
Certification/Extension First Submitted that Passed QC Review
Apr 30, 2014
Certification/Extension First Posted Date
May 16, 2014Estimated
Last Update Submitted Date
Jul 28, 2016
Last Update Posted Date
Sep 20, 2016Estimated
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
The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.
The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.
Detailed Description
Not provided
Conditions Module
Conditions
Carcinoma, Non-Small-Cell Lung
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
143Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BI 6727 +pemetrexed
Experimental
BI 6727 plus 500 mg/^m2 pemetrexed i.v. on day 1 of 21 day cycle
Drug: pemetrexed
Drug: BI 6727
pemetrexed
Active Comparator
500 mg/m^2 i.v. on day 1 of a 21 day cycle
Drug: pemetrexed
Interventions
Name
Type
Description
Arm Group Labels
Other Names
pemetrexed
Drug
500 mg/m^2 i.v. on day 1 of 21 day cycle
BI 6727 +pemetrexed
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.
Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.
The number of participants analysed displays the number of patients with an event (progression).
From randomization until disease progression or death
Secondary Outcomes
Measure
Description
Time Frame
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Pathologic or cytologic confirmed diagnosis of NSCLC
Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
Patients who are eligible for pemetrexed as second line chemotherapy
Measurable disease by one or more techniques (CT, MRI) according to RECIST
Patients aged 18 years or older
Life expectancy of at least three (3) months
Eastern Cooperative Oncology Group (ECOG) performance Score 0-2
Written informed consent that is consistent with ICH-GCP guidelines and local legislation
Exclusion criteria:
Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of Cycle 1 of this trial
Any persisting toxicities which are deemed to be clinically significant from the previous therapy
Patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded.
Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
Patients unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily
Patients who have received prior therapy with pemetrexed
Absolute neutrophil count (ANC) less than 1,500/mm3
Platelet count less than 100,000/mm3
Hemoglobin <90g/L
Total bilirubin >26µmol/L
Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
Ellis PM, Leighl NB, Hirsh V, Reaume MN, Blais N, Wierzbicki R, Sadrolhefazi B, Gu Y, Liu D, Pilz K, Chu Q. A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 Nov;16(6):457-65. doi: 10.1016/j.cllc.2015.05.010. Epub 2015 Jun 2.
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Overall Survival (OS)
Overall survival (OS) was defined as the duration of time from randomization to time of death.
From randomization until time of death
Duration of Overall Response
The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.
From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
Occurrence and Intensity of AEs Graded According to CTCAE.
All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE).
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Occurence of DLT
Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:
treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).
treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.
CTCAE Grade 4 thrombocytopenia.
Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.
Frequency of Patients With Possible Clinically Significant Abnormalities
Frequency of patients with possible clinically significant abnormalities
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Cmax of Volasertib
Cmax - maximum measured concentration of volasertib in plasma.
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Total Clearance (CL) of Volasertib
CL - total clearance of volasertib in plasma after IV administration
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss of Volasertib
Vss - apparent volume of distribution at steady state following IV administration of volasertib
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax of Pemetrexed
Cmax - maximum measured concentration of pemetrexed in plasma
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL of Pemetrexed
CL - total clearance of pemetrexed in plasma after IV administration
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss of Pemetrexed
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Kelowna
British Columbia
Canada
1230.5.00109 Boehringer Ingelheim Investigational Site
Surrey
British Columbia
Canada
1230.5.00107 Boehringer Ingelheim Investigational Site
Vancouver
British Columbia
Canada
1230.5.00105 Boehringer Ingelheim Investigational Site
Hamilton
Ontario
Canada
1230.5.00119 Boehringer Ingelheim Investigational Site
Kitchener
Ontario
Canada
1230.5.00116 Boehringer Ingelheim Investigational Site
Oshawa
Ontario
Canada
1230.5.00108 Boehringer Ingelheim Investigational Site
Ottawa
Ontario
Canada
1230.5.00110 Boehringer Ingelheim Investigational Site
Toronto
Ontario
Canada
1230.5.00102 Boehringer Ingelheim Investigational Site
Montreal
Quebec
Canada
1230.5.00106 Boehringer Ingelheim Investigational Site
Montreal
Quebec
Canada
1230.5.00118 Boehringer Ingelheim Investigational Site
Nassau
The Bahamas
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
FG002
Randomized Phase: Volasertib 300 mg
Patients received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
BG004
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG00237
BG00347
BG00447
BG005143
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
BG00066.2± 8.30
BG00162.3± 6.83
BG00262.9± 8.60
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0014
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
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.
Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.
The number of participants analysed displays the number of patients with an event (progression).
Randomized phase II set, which included all patients who were randomized as part of phase II of the study (not the run in phase)
Posted
Median
95% Confidence Interval
months
From randomization until disease progression or death
ID
Title
Description
OG000
Randomization Phase: Volasertib 300 mg
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
OG002
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
Units
Counts
Participants
OG00034
OG00143
OG00239
Title
Denominators
Categories
Title
Measurements
OG0001.4(1.2 to 1.9)
OG0013.3(1.9 to 5.7)
OG0025.3(3.1 to 7.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard ratio and 95% confidence interval (CI) from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).
Log Rank
0.0030
Hazard Ratio (HR)
2.045
2-Sided
95
1.271
3.292
No
Superiority or Other
Secondary
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.
Randomized set
Posted
Number
percentage of participants
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
OG002
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
Units
Counts
Participants
Secondary
Duration of Overall Response
The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.
Randomized phase II set
Posted
Median
Inter-Quartile Range
weeks
From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
ID
Title
Description
OG000
Randomization Phase: Volasertib 300 mg
Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
OG002
Randomization Phase: Pemetrexed 500 mg/m2
Secondary
Occurrence and Intensity of AEs Graded According to CTCAE.
All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE).
Treated set, which included all patients who were dispensed and were documented to have taken at least one dose of investigational treatment.
Posted
Number
participants
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
Secondary
Cmax of Volasertib
Cmax - maximum measured concentration of volasertib in plasma.
Pharmacokinetic (PK) set, which included all patients in the treated set with volasertib monotherapy or combined with pemetrexed and provided at least 1 blood sample for measurement of volasertib (BI 6727) or pemetrexed. Including patients with evaluable data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
ID
Title
Description
OG000
Volasertib 250 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
OG001
Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
OG002
Volasertib 300 mg
Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
Secondary
Total Clearance (CL) of Volasertib
CL - total clearance of volasertib in plasma after IV administration
PK set including patients with evaluable data
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/min
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
ID
Title
Description
OG000
Volasertib 250 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
OG001
Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
OG002
Volasertib 300 mg
Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
Units
Counts
Secondary
Vss of Volasertib
Vss - apparent volume of distribution at steady state following IV administration of volasertib
PK set including patients with evaluable data
Posted
Geometric Mean
Geometric Coefficient of Variation
Litres
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
ID
Title
Description
OG000
Volasertib 250 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
OG001
Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
OG002
Volasertib 300 mg
Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
Units
Counts
Secondary
Cmax of Pemetrexed
Cmax - maximum measured concentration of pemetrexed in plasma
PK set including patients with evaluable data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
ID
Title
Description
OG000
Volasertib 250 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
OG001
Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
Units
Counts
Participants
OG000
Secondary
CL of Pemetrexed
CL - total clearance of pemetrexed in plasma after IV administration
PK set including patients with evaluable data
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/min
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
ID
Title
Description
OG000
Volasertib 250 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
OG001
Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
Units
Counts
Participants
OG000
Secondary
Vss of Pemetrexed
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed
PK set including patients with evaluable data
Posted
Geometric Mean
Geometric Coefficient of Variation
Litres
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
ID
Title
Description
OG000
Volasertib 250 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
OG001
Volasertib 300 mg + Pemetrexed 500 mg/m2
Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
Units
Counts
Participants
OG000
Time Frame
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
10
46
46
46
EG004
Randomization Phase: Pemetrexed 500 mg/m2
Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
12
46
44
46
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 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG0030 affected46 at risk
EG0041 affected46 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Arrhythmia
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Atrial fibrillation
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Atrial flutter
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Ascites
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Chest pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Death
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Fatigue
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Pyrexia
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Thrombosis in device
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Cellulitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Diverticulitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Lung infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Neutropenic infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Oral candidiasis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Pneumonia bacterial
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Septic shock
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Aphasia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Convulsion
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Headache
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Hemiparesis
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 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
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0024 affected36 at risk
EG00312 affected46 at risk
EG0044 affected46 at risk
Leukopenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0029 affected36 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected36 at risk
EG003
Palpitations
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Tachycardia
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0022 affected36 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Ear pain
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Vertigo
Ear and labyrinth disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected36 at risk
EG003
Dry eye
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected6 at risk
EG0020 affected36 at risk
EG003
Eye irritation
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Eye oedema
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Lacrimation increased
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0021 affected36 at risk
EG003
Vision blurred
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0026 affected36 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0024 affected36 at risk
EG003
Dry mouth
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0023 affected36 at risk
EG003
Flatulence
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected36 at risk
EG003
Lip blister
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Nausea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0004 affected6 at risk
EG0014 affected6 at risk
EG0025 affected36 at risk
EG003
Stomatitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0027 affected36 at risk
EG003
Asthenia
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0024 affected36 at risk
EG003
Catheter site pruritus
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Chest pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected6 at risk
EG0024 affected36 at risk
EG003
Chills
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected36 at risk
EG003
Fatigue
General disorders
MEDDRA 15.1
Systematic Assessment
EG0005 affected6 at risk
EG0016 affected6 at risk
EG00220 affected36 at risk
EG003
General physical health deterioration
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Influenza like illness
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Injection site discomfort
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Injection site pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Mucosal inflammation
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Non-cardiac chest pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Oedema peripheral
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0024 affected36 at risk
EG003
Pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected36 at risk
EG003
Puncture site haemorrhage
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Pyrexia
General disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0023 affected36 at risk
EG003
Candidiasis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Cystitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Herpes zoster
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Influenza
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Nasopharyngitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0024 affected36 at risk
EG003
Oral herpes
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Respiratory tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Tooth abscess
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0022 affected36 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Alanine aminotransferase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Aspartate aminotransferase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Blood albumin decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Blood creatinine increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Breath sounds abnormal
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Carbohydrate antigen 125 increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Creatinine renal clearance decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Glomerular filtration rate decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Heart rate increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Hepatic enzyme increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Neutrophil count decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Neutrophil count increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Platelet count decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0023 affected36 at risk
EG003
Weight decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Weight increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
White blood cell count decreased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
White blood cell count increased
Investigations
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0003 affected6 at risk
EG0014 affected6 at risk
EG0023 affected36 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0024 affected36 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG00212 affected36 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0023 affected36 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0024 affected36 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0024 affected36 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected6 at risk
EG0025 affected36 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Convulsion
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected6 at risk
EG0027 affected36 at risk
EG003
Dysgeusia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Headache
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0022 affected36 at risk
EG003
Hypoaesthesia
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected36 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected36 at risk
EG003
Somnolence
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Syncope
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Abnormal dreams
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Anxiety
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Confusional state
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Insomnia
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Dysuria
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0025 affected36 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0026 affected36 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected36 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0025 affected36 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0023 affected36 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected36 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0025 affected36 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0021 affected36 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected36 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0021 affected36 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0024 affected36 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Flushing
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected36 at risk
EG003
Hypertension
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected6 at risk
EG0020 affected36 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
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D002289
Carcinoma, Non-Small-Cell Lung
Ancestor Terms
ID
Term
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068437
Pemetrexed
C541363
BI 6727
Ancestor Terms
ID
Term
D006147
Guanine
D007042
Hypoxanthines
D011688
Purinones
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D005971
Glutamates
D024342
Amino Acids, Acidic
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
D000600
Amino Acids, Dicarboxylic
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
FG0041 subjectsOn-treatment at data cutoff (21Dec2012)
46 subjects
1 subjects
FG0041 subjects
Progressive disease
FG0000 subjects
FG0010 subjects
FG00225 subjects
FG00336 subjects
FG00434 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0035 subjects
FG0045 subjects
Refused to continue medication
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
Other reason not defined above
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0032 subjects
FG0044 subjects
63.5
± 10.26
BG00462.5± 8.89
BG00563.1± 9.12
16
BG00323
BG00425
BG00573
Male
BG0001
BG0012
BG00221
BG00324
BG00422
BG00570
OG001
OG002
Hazard ratio and 95% CI from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg/m2; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).