Clinical Trial Results:
Home Delivery of Pemetrexed as Maintenance Treatment in Patients Who Have Not Progressed after Induction Therapy for Advanced Nonsquamous Nonsmall Cell Lung Cancer: A Feasibility Study
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Summary
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EudraCT number |
2011-000841-19 |
Trial protocol |
SE GB |
Global end of trial date |
23 Sep 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Jul 2016
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First version publication date |
16 Jul 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
H3E-EW-S133
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01473563 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Trial ID: 14079, Trail Alias: H3E-EW-S133 | ||
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Sponsors
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Sponsor organisation name |
Eli Lilly and Company
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Sponsor organisation address |
Lilly Corporate Center, Indianapolis, IN, United States, 46285
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Public contact |
Available Mon - Fri 9 AM - 5PM EST, Eli Lilly and Company, 1 877-CTLilly,
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Scientific contact |
Available Mon - Fri 9 AM - 5PM EST, Eli Lilly and Company, 1 877-285-4559,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Sep 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Sep 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the adherence rate to pemetrexed administered in a domiciliary setting.
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Protection of trial subjects |
This study was conducted in accordance with International Code of Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Dec 2011
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 43
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Country: Number of subjects enrolled |
Sweden: 9
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Worldwide total number of subjects |
52
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EEA total number of subjects |
52
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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From 65 to 84 years |
28
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
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Pre-assignment
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Screening details |
During screening, 5 patients failed to meet study eligibility criteria and 1 patient was not enrolled due to an Adverse Event (AE). | ||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Study Treatment | ||||||||||||
Arm description |
Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (IV) infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Pemetrexed
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Investigational medicinal product code |
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Other name |
LY231514, Alimta, Pemetrexed disodium, Pemetrexed sodium hydrate
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
500 milligrams per square meter (mg/m^2) pemetrexed administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Maintenance therapy administered until disease progression or the participant is discontinued for any other reason. The first dose of maintenance therapy will be administered at the hospital; thereafter, therapy will be administered in the home setting by qualified oncology homecare nurses.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Study Treatment
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Reporting group description |
Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (IV) infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses. | ||
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End point title |
Percentage of Participants Who Adhered to Treatment Administration at Home [1] | ||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Participants were considered adherent from the time of the first dose in Cycle 1 (hospital administration) until either the last day of the cycle when the participant reverted to pemetrexed hospital administration or the last day of the cycle when the participant discontinued study treatment or the study for reasons related to the home setting. The percentage of participants who adhered to treatment administration at home was estimated by a Kaplan-Meier survival analyses approach. Participants who died or discontinued the study and treatment without reverting to hospital administration were censored at the time of discontinuation.
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End point type |
Primary
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End point timeframe |
Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics are used to represent rates of adherence to home delivery for each cycle based on the Kaplan-Meier approach and are expressed as proportions (percentage of participants) and reported with the corresponding 95% confidence intervals. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS) | ||||||||||||||
End point description |
The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline in EQ-5D VAS is reported.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Change From Baseline in the EQ-5D Index Score | ||||||||||||||
End point description |
The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline EQ-5D Index score is reported and the EQ-5D Index score was calculated by converting health state scores into a weighted health state index according to a United Kingdom population-based algorithm. The possible values for the EQ-5D Index score range from −0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), on a scale where 1 represents the best possible health state.
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End point type |
Secondary
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End point timeframe |
Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores | ||||||||||||||||||||||||||
End point description |
LCSS is a 9-item questionnaire; 6 items are symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe overall symptomatic distress, interference with activity level, and overall quality of life during the past 24 hours. Participant responses were measured using a VAS with 100-millimeter (mm) lines. Scores ranged from 0 mm (no symptoms and no impact on activities, quality of life) to 100 mm (symptoms as bad as they could be, impacting activities and quality of life).
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End point type |
Secondary
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End point timeframe |
Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Participant Satisfaction: Chemotherapy at Hospital | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Participants were asked to evaluate their hospital experiences in this study by answering 4 questions (Q). Q1: "What do you consider advantages of having chemotherapy at the hospital? Choose all that apply." Choices included: "Support from other patients", "Access to other medical specialists", "Access to more technical services", "Safer in case something goes wrong", and "Other". Q2: "What do you consider disadvantages of having chemotherapy at the hospital? Choose all that apply." Choices included: "Need to travel", "Having to wait for treatment", "Not having a personalized treatment", "Lack of privacy on the ward", and "Other". Q3: "How would you rate your overall satisfaction with chemotherapy at the hospital?" and Q4: "How would you rate your overall satisfaction with the nursing staff during chemotherapy at the hospital?" Choices for Q3 and Q4 included: "Very dissatisfied", "Somewhat dissatisfied", "Neither satisfied nor dissatisfied", "Somewhat satisfied", or "Very satisfied".
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End point type |
Secondary
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End point timeframe |
The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Participant Satisfaction: Chemotherapy at Home | ||||||||||||||||||||||||||||||||||||||
End point description |
Participants were asked to evaluate their home treatment experiences in this study by answering 4 questions (Q). Q5: "What do you do consider advantages of having chemotherapy at home? Choose all that apply." Choices included: "No need to travel", "Not having to wait for treatment", "Personalized service", "More privacy", and "Other". Q6:"What do you consider disadvantages of having chemotherapy at home? Choose all that apply." Choices included: "Lack of other patients’ support", "Extra burden for family/friends", "Safety concerns", "Need to rely on 1 medical specialist", and "Other". Q7: "How would you rate your overall satisfaction with chemotherapy at home?" Choices included: "Very dissatisfied", "Somewhat dissatisfied", "Neither satisfied nor dissatisfied", "Somewhat satisfied", or "Very satisfied".
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End point type |
Secondary
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End point timeframe |
The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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End point title |
Participant Satisfaction: Regarding the Study Nurse | ||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Participants were asked 7 questions (Q) about their study nurse for home treatment. Q8: "Was the nurse an easy person to talk to?", Q9: "When the nurse came, did you feel he/she had enough time to do the required things?", Q10: "Do you think the nurse had time to discuss things with you?", Q11: "Did you feel that the nurse knew enough about you and your illness?" Choices for Q8 through Q11 included: "Yes" or "No". Q12: "Were you able to get all the information you wanted about your illness or treatment?" Choices included: "Yes", "No", or "Uncertain". Q13: "Would you say that the nurse gave…" Choices included: "a lot of reassurance and support", "some reassurance and support", or "hardly any reassurance and support". Q14: "How would you rate your overall satisfaction with the nursing staff during chemotherapy at home?" Choices included: "Very dissatisfied", "Somewhat dissatisfied", "Neither satisfied nor dissatisfied", "Somewhat satisfied", or "Very satisfied".
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End point type |
Secondary
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End point timeframe |
The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment | ||||||||||||||||||||
End point description |
Participants were asked to evaluate their preferences regarding home and/or hospital treatment delivery in this study by answering 2 questions (Q). Q15: "Do you prefer having your chemotherapy at home or at the hospital, or are you indifferent?" Choices included: "Home", "Hospital", or "Indifferent". Q16: "Would you recommend having chemotherapy at home to someone else in your same situation?" Choices included: "Yes", "No", or "Not sure".
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End point type |
Secondary
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End point timeframe |
The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Physician Satisfaction: Distant Management of Participant | ||||||||||||||||||
End point description |
The physician was asked, "How would you rate your overall satisfaction with the distant management of the participant during chemotherapy at home?" Choices included: "Very dissatisfied", "Somewhat dissatisfied", "Neither satisfied nor dissatisfied", "Somewhat satisfied", or "Very satisfied".
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End point type |
Secondary
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End point timeframe |
30 days post treatment discontinuation
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources | ||||||||||
End point description |
The number of participants who had at least 1 unplanned use of health care resources [accident and emergency department (dept.), specialists [oncologist, pulmonologist, etcetera (etc.)], general practitioner (GP) or family doctor, or diagnostic procedures] during the study is reported
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End point type |
Secondary
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End point timeframe |
Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)
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| No statistical analyses for this end point | |||||||||||
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End point title |
Resource Utilization: Duration of Health Care Visits | ||||||||||||||
End point description |
The duration of the health care visit in the home setting is reported. The visit started when the nurse arrived and included the entire treatment process. The visit ended when the nurse left the home setting. Due to the limited number of participants with evaluable data, results are reported for Cycles 2 through 4.
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End point type |
Secondary
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End point timeframe |
Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Resource Utilization: Distances Traveled | ||||||||||||||||||||||||
End point description |
The distance traveled is reported by region (Great Britain and Sweden) and includes the distance traveled by the participant from his/her home to the hospital (Cycle 1) and other cycles where the homecare nurse traveled from the hospital to the participant's home. Due to the limited number of participants with evaluable data, results are reported for Cycles 1 through 4.
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End point type |
Secondary
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End point timeframe |
Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Overall Survival (OS) at 6 Months | ||||||||||
End point description |
The percentage of participants who were alive at Month 6 was calculated as a cumulative percentage by Kaplan-Meier survival analyses approach. For participants not known to have died as of the cut-off date, OS was censored as the last contact date (known alive).
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End point type |
Secondary
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End point timeframe |
Cycle 1, Day 1 to the date of death from any cause (up to Month 6)
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| No statistical analyses for this end point | |||||||||||
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End point title |
Time to Treatment Failure (TTF) | ||||||||||
End point description |
The time from the date of the first dose of study treatment (Cycle 1, Day 1) to the date of death from any cause, PD (clinical and objective), or discontinuation of pemetrexed due to toxicity. Response was defined using RECIST, v1.1 criteria. PD was defined as having at least a 20% increase in the sum of the longest diameter of target lesions and at a minimum 5 mm increase above nadir. TTF was censored at the date of the last visit for participants who did not discontinue pemetrexed, who were still alive, and who had not progressed.
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End point type |
Secondary
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End point timeframe |
Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle)
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| No statistical analyses for this end point | |||||||||||
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End point title |
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services | ||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The unplanned use of any 1 of the following 4 resources is reported, as well as the unplanned use of each resource: accident and emergency dept., specialists (oncologist, pulmonologist etc.), GP or family doctor, and diagnostic procedures. Results are reported as the number of participants with an unplanned resource use (visit) for a specified number of times.
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End point type |
Secondary
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End point timeframe |
Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died | ||||||||||||||||||
End point description |
The number of participants who had at least 1 TEAE or serious TEAE (regardless of causality) is reported along with the number of participants who died (due to any cause) while on therapy or during treatment discontinuation follow-up (up to 6 months). TEAEs started on or after the date and time of first dose of study drug, or started prior to study drug but worsened after study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
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End point type |
Other pre-specified
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End point timeframe |
First dose of study drug (Cycle 1, Day 1) through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
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| No statistical analyses for this end point | |||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Entire Study
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Adverse event reporting additional description |
H3E-EW-S133
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Pemetrexed 500 mg/m2
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
