Trial Outcomes & Findings for LUME BioNIS: a Biomarker Study in Patients With NSCLC (NCT NCT02671422)
NCT ID: NCT02671422
Last Updated: 2020-09-24
Results Overview
Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS \[days\] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) \[days\] = date of last contact when the Patient was known to be alive - date of treatment start + 1.
Recruitment status
COMPLETED
Target enrollment
260 participants
Primary outcome timeframe
From start of entering the study until death or last contact date, up to 42 months.
Results posted on
2020-09-24
Participant Flow
Non-interventional study based on newly collected data in patients with Non-Small Cell Lung Cancer of adenocarcinoma tumour, who, for the first time, received Vargatef® as part of the routine treatment according to the approved label (new users design), to explore whether genetic or genomic markers could be used to predict Overall Survival.
Only subjects that met all the study inclusion criteria were to be entered in the study. All subjects were free to withdraw from the non-interventional study at any time for any reason given.
Participant milestones
| Measure |
200mg Vargatef®
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.
Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first.
|
|---|---|
|
Overall Study
STARTED
|
260
|
|
Overall Study
Not Treated With Vargatef®
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
260
|
Reasons for withdrawal
| Measure |
200mg Vargatef®
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.
Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Adverse Event
|
68
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Progressive Disease
|
156
|
|
Overall Study
Worsening of Disease
|
4
|
|
Overall Study
Sponsor decision
|
5
|
|
Overall Study
Adverse Event unrelated to Vargatef®
|
8
|
|
Overall Study
Not treated with Vargatef®
|
3
|
|
Overall Study
Other not defined above
|
3
|
Baseline Characteristics
LUME BioNIS: a Biomarker Study in Patients With NSCLC
Baseline characteristics by cohort
| Measure |
200mg Vargatef®
n=260 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.
Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first.
|
|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
256 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of entering the study until death or last contact date, up to 42 months.Population: Entered Set: All patients who entered the study, no matter if they actually had taken Vargatef®.
Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS \[days\] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) \[days\] = date of last contact when the Patient was known to be alive - date of treatment start + 1.
Outcome measures
| Measure |
200mg Vargatef®
n=260 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.
Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first.
|
|---|---|
|
Number of Participants With Overall Survival (OS) Event
|
206 Participants
|
Adverse Events
200mg Vargatef®
Serious events: 127 serious events
Other events: 93 other events
Deaths: 209 deaths
Serious adverse events
| Measure |
200mg Vargatef®
n=257 participants at risk
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.
Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first.
|
|---|---|
|
Nervous system disorders
Coma
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Nervous system disorders
Dizziness
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Nervous system disorders
Ischaemic stroke
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Nervous system disorders
Seizure
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Product Issues
Device occlusion
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Renal and urinary disorders
Urinary retention
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.9%
10/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Cardiac disorders
Cardiac arrest
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Cardiac disorders
Tachycardia
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Eye disorders
Vision blurred
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
9/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Enteritis
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Haematemesis
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Ileus
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
3/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
4/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Chest pain
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Death
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
General physical health deterioration
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Malaise
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Mucosal inflammation
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Pain
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Performance status decreased
|
1.2%
3/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Pyrexia
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Clostridial infection
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Device related infection
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Fournier's gangrene
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Infection
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Influenza
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Neutropenic sepsis
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Perirectal abscess
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Pneumonia
|
5.1%
13/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Pulmonary sepsis
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Respiratory tract infection
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Sepsis
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Infections and infestations
Septic shock
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Investigations
Alanine aminotransferase increased
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Investigations
Aspartate aminotransferase increased
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Investigations
C-reactive protein increased
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Investigations
White blood cell count decreased
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.78%
2/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
3/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.7%
66/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Nervous system disorders
Aphasia
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Nervous system disorders
Cerebral infarction
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
4/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
3/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
4/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
3/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Vascular disorders
Embolism
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Vascular disorders
Vena cava thrombosis
|
0.39%
1/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
Other adverse events
| Measure |
200mg Vargatef®
n=257 participants at risk
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.
Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
26.8%
69/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
24/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
15/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
General disorders
Fatigue
|
7.8%
20/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.8%
15/257 • From first administration of study medication (Vargatef®) until 30 days after the last administration of study medication (Vargatef®), up to 807 days.
For All-Cause Mortality the entered set (All patients who entered the study, no matter if they actually had taken Vargatef® ) was used. For serious and other adverse events, the Treated Set (All patients who were documented to have taken at least 1 Vargatef® dose) was used.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place