Trial Outcomes & Findings for A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (NCT NCT01473563)
NCT ID: NCT01473563
Last Updated: 2014-10-06
Results Overview
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.
COMPLETED
PHASE2
52 participants
Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)
2014-10-06
Participant Flow
Participants who completed study treatment and follow-up (FU) were considered to have completed the study. Participants received treatment until disease progression or discontinuation and were followed post treatment (post tx) discontinuation for up to 6 months.
Participant milestones
| Measure |
Pemetrexed
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.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
52
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pemetrexed
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.
|
|---|---|
|
Overall Study
Lost to FU post tx discontinuation
|
1
|
Baseline Characteristics
A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=52 Participants
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.
|
|---|---|
|
Age, Continuous
|
66.0 years
FULL_RANGE 12.05 • n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
48 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
43 participants
n=93 Participants
|
|
Region of Enrollment
Sweden
|
9 participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0: Fully Active
|
14 participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1: Restricted
|
38 participants
n=93 Participants
|
|
Most Recent Pathological Diagnosis
Adenocarcinoma, Lung
|
48 participants
n=93 Participants
|
|
Most Recent Pathological Diagnosis
Adenocarcinoma, Mucinous, No Other Symptoms (NOS)
|
1 participants
n=93 Participants
|
|
Most Recent Pathological Diagnosis
Adenocarcinoma, Moderately Differentiated, Lung
|
1 participants
n=93 Participants
|
|
Most Recent Pathological Diagnosis
Carcinoma, Non-Small Cell, Lung NOS
|
2 participants
n=93 Participants
|
|
Basis for Most Recent Pathological Diagnosis
Cytological
|
10 participants
n=93 Participants
|
|
Basis for Most Recent Pathological Diagnosis
Histopathological
|
42 participants
n=93 Participants
|
|
Stage of Disease
Stage IIIB
|
3 participants
n=93 Participants
|
|
Stage of Disease
Stage IV
|
48 participants
n=93 Participants
|
|
Stage of Disease
Stage IIIA
|
1 participants
n=93 Participants
|
|
Prior Systemic Therapy
Carboplatin + Gemcitabine
|
9 participants
n=93 Participants
|
|
Prior Systemic Therapy
Carboplatin + Pemetrexed
|
19 participants
n=93 Participants
|
|
Prior Systemic Therapy
Cisplatin + Pemetrexed
|
20 participants
n=93 Participants
|
|
Prior Systemic Therapy
Platinum-Based Therapy + Pemetrexed
|
4 participants
n=93 Participants
|
|
Best Response to Prior Systemic Therapy
Partial Response (PR)
|
25 participants
n=93 Participants
|
|
Best Response to Prior Systemic Therapy
Stable Disease (SD)
|
26 participants
n=93 Participants
|
|
Best Response to Prior Systemic Therapy
Progressive Disease (PD)
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)Population: Intention-to-Treat (ITT) population: Participants who received at least 1 dose of study drug. The number of participants censored was 6, 9, 7, 8, 7, 1, 0, 2, 2, 2, 2, 0, 3, 0, 0, 0, 0, 0, and 1 for Cycles 1 through 19, respectively.
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.
Outcome measures
| Measure |
Pemetrexed
n=52 Participants
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.
|
|---|---|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 1, Hospital Delivery
|
100 percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 2, Home Delivery
|
98.0 percentage of participants
Interval 86.4 to 99.7
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 3, Home Delivery
|
98.0 percentage of participants
Interval 86.4 to 99.7
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 4, Home Delivery
|
98.0 percentage of participants
Interval 86.4 to 99.7
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 5, Home Delivery
|
98.0 percentage of participants
Interval 86.4 to 99.7
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 6, Home Delivery
|
98.0 percentage of participants
Interval 86.4 to 99.7
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 7, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 8, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 9, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 10, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 11, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 12, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 13, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 14, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 15, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 16, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 17, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 18, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
|
Percentage of Participants Who Adhered to Treatment Administration at Home
Cycle 19, Home Delivery
|
90.7 percentage of participants
Interval 61.7 to 98.1
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuationPopulation: Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D VAS assessment.
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.
Outcome measures
| Measure |
Pemetrexed
n=34 Participants
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.
|
|---|---|
|
Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)
Cycle 2 (n=34)
|
3.0 units on a scale
Standard Deviation 18.6
|
|
Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)
Cycle 4 (n=20)
|
7.7 units on a scale
Standard Deviation 21.7
|
|
Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)
30 days post treatment discontinuation (n=22)
|
-0.9 units on a scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuationPopulation: Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D index assessment.
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.
Outcome measures
| Measure |
Pemetrexed
n=38 Participants
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.
|
|---|---|
|
Change From Baseline in the EQ-5D Index Score
Cycle 2 (n=38)
|
0.03 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in the EQ-5D Index Score
Cycle 4 (n=23)
|
0.08 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline in the EQ-5D Index Score
30 days post treatment discontinuation (n=26)
|
-0.9 units on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuationPopulation: Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline LCSS assessment.
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).
Outcome measures
| Measure |
Pemetrexed
n=43 Participants
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.
|
|---|---|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Interference With Activity Level (n=43)
|
15.3 mm
Standard Deviation 25.1
|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Loss of Appetite (n=43)
|
16.3 mm
Standard Deviation 22.0
|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Fatigue (n=43)
|
24.5 mm
Standard Deviation 27.2
|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Cough (n=41)
|
9.2 mm
Standard Deviation 19.7
|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Dyspnea (n=41)
|
17.2 mm
Standard Deviation 26.7
|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Hemoptysis (n=43)
|
0.4 mm
Standard Deviation 4.3
|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Pain (n=40)
|
11.8 mm
Standard Deviation 25.1
|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Overall Symptomatic Distress (n=43)
|
8.3 mm
Standard Deviation 22.3
|
|
Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores
Overall Quality of Life (n=41)
|
12.2 mm
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuationPopulation: Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.
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".
Outcome measures
| Measure |
Pemetrexed
n=39 Participants
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.
|
|---|---|
|
Participant Satisfaction: Chemotherapy at Hospital
Q1, Support from other patients
|
8 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q1, Access to other medical specialists
|
19 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q1, Access to more technical services
|
12 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q1, Safer in case something goes wrong
|
19 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q1, Other
|
3 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q2, Need to travel
|
36 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q2, Having to wait for treatment
|
27 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q2, Not having a personalized treatment
|
5 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q2, Lack of privacy on the ward
|
7 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q2, Other
|
1 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q3, Very dissatisfied
|
0 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q3, Somewhat dissatisfied
|
3 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q3, Neither satisfied nor dissatisfied
|
3 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q3, Somewhat satisfied
|
11 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q3, Very satisfied
|
21 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q4, Very dissatisfied
|
3 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q4, Somewhat dissatisfied
|
0 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q4, Neither satisfied nor dissatisfied
|
0 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q4, Somewhat satisfied
|
3 participants
|
|
Participant Satisfaction: Chemotherapy at Hospital
Q4, Very satisfied
|
32 participants
|
SECONDARY outcome
Timeframe: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuationPopulation: Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.
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".
Outcome measures
| Measure |
Pemetrexed
n=39 Participants
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.
|
|---|---|
|
Participant Satisfaction: Chemotherapy at Home
Q5, No need to travel
|
37 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q5, Not having to wait for treatment
|
27 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q5, Personalized service
|
28 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q5, More privacy
|
20 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q5, Other
|
2 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q6, Lack of other patients' support
|
5 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q6, Extra burden for family/friends
|
1 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q6, Safety concerns
|
4 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q6, Need to rely on 1 medical specialist
|
7 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q6, Other
|
19 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q7, Very dissatisfied
|
1 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q7, Somewhat dissatisfied
|
0 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q7, Neither satisfied nor dissatisfied
|
2 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q7, Somewhat satisfied
|
1 participants
|
|
Participant Satisfaction: Chemotherapy at Home
Q7, Very Satisfied
|
30 participants
|
SECONDARY outcome
Timeframe: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuationPopulation: Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.
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".
Outcome measures
| Measure |
Pemetrexed
n=38 Participants
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.
|
|---|---|
|
Participant Satisfaction: Regarding the Study Nurse
Q8, Yes
|
37 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q8, No
|
0 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q9, Yes
|
36 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q9, No
|
1 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q10, Yes
|
37 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q10, No
|
1 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q11, Yes
|
36 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q11, No
|
0 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q12, Yes
|
34 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q12, No
|
0 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q12, Uncertain
|
3 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q13, Hardly any reassurance and support
|
0 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q13, Some reassurance and support
|
2 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q13, A lot of reassurance and support
|
35 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q14, Very dissatisfied
|
3 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q14, Somewhat dissatisfied
|
0 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q14, Neither satisfied nor dissatisfied
|
1 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q14, Somewhat satisfied
|
1 participants
|
|
Participant Satisfaction: Regarding the Study Nurse
Q14, Very satisfied
|
33 participants
|
SECONDARY outcome
Timeframe: The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuationPopulation: Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.
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".
Outcome measures
| Measure |
Pemetrexed
n=38 Participants
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.
|
|---|---|
|
Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
Q15, Home
|
33 participants
|
|
Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
Q15, Hospital
|
0 participants
|
|
Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
Q15, Indifferent
|
5 participants
|
|
Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
Q16, Yes
|
37 participants
|
|
Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
Q16, No
|
0 participants
|
|
Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment
Q16, Not sure
|
0 participants
|
SECONDARY outcome
Timeframe: 30 days post treatment discontinuationPopulation: Participants who received at least 1 dose of study drug and for whom the investigator answered the specified question at 30 days post treatment discontinuation.
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".
Outcome measures
| Measure |
Pemetrexed
n=31 Participants
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.
|
|---|---|
|
Physician Satisfaction: Distant Management of Participant
Very Dissatisfied
|
2 investigators
|
|
Physician Satisfaction: Distant Management of Participant
Somewhat Dissatisfied
|
1 investigators
|
|
Physician Satisfaction: Distant Management of Participant
Neither Satisfied Nor Dissatisfied
|
0 investigators
|
|
Physician Satisfaction: Distant Management of Participant
Somewhat Satisfied
|
8 investigators
|
|
Physician Satisfaction: Distant Management of Participant
Very Satisfied
|
20 investigators
|
SECONDARY outcome
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)Population: ITT population: Participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Pemetrexed
n=52 Participants
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.
|
|---|---|
|
Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources
|
29 participants
|
SECONDARY outcome
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)Population: Participants who received at least 1 dose of study drug and had at least 1 unplanned use of health care resources.
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.
Outcome measures
| Measure |
Pemetrexed
n=29 Participants
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.
|
|---|---|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
1 Unplanned Visit, Any Resource
|
8 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
2 Unplanned Visits, Any Resource
|
6 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
3 Unplanned Visits, Any Resource
|
5 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
4 Unplanned Visits, Any Resource
|
2 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
5 Unplanned Visits, Any Resource
|
3 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
9 Unplanned Visits, Any Resource
|
1 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
10 Unplanned Visits, Any Resource
|
1 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
13 Unplanned Visits, Any Resource
|
1 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
1 Unplanned Visit, Accident and Emergency Dept.
|
7 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
2 Unplanned Visits, Accident and Emergency Dept.
|
2 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
3 Unplanned Visits, Accident and Emergency Dept.
|
2 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
1 Unplanned Visit, Specialist
|
9 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
2 Unplanned Visits, Specialist
|
3 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
5 Unplanned Visits, Specialist
|
1 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
1 Unplanned Visit, GP or Family Doctor
|
6 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
2 Unplanned Visits, GP or Family Doctor
|
3 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
3 Unplanned Visits, GP or Family Doctor
|
2 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
4 Unplanned Visits, GP or Family Doctor
|
3 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
1 Unplanned Visit, Diagnostic procedures
|
6 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
2 Unplanned Visits, Diagnostic procedures
|
2 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
3 Unplanned Visits, Diagnostic procedures
|
3 participants
|
|
Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services
4 Unplanned Visits, Diagnostic procedures
|
1 participants
|
SECONDARY outcome
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)Population: Participants who received at least 1 dose of study drug and had at least 1 health care visit in the home setting from Cycle 2 through Cycle 4.
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.
Outcome measures
| Measure |
Pemetrexed
n=42 Participants
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.
|
|---|---|
|
Resource Utilization: Duration of Health Care Visits
Cycle 2 (n=42)
|
1.67 hours
Standard Deviation 0.493
|
|
Resource Utilization: Duration of Health Care Visits
Cycle 3 (n=35)
|
1.66 hours
Standard Deviation 0.683
|
|
Resource Utilization: Duration of Health Care Visits
Cycle 4 (n=28)
|
1.57 hours
Standard Deviation 0.311
|
SECONDARY outcome
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)Population: Participants who received at least 1 dose of study drug and had data for distance traveled for at least 1 cycle from Cycle 1 through Cycle 4.
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.
Outcome measures
| Measure |
Pemetrexed
n=32 Participants
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.
|
|---|---|
|
Resource Utilization: Distances Traveled
Cycle 1, Home to Hospital, Great Britain (n=25)
|
19.7 kilometers (km)
Standard Deviation 23.39
|
|
Resource Utilization: Distances Traveled
Cycle 1, Home to Hospital, Sweden (n=7)
|
30.7 kilometers (km)
Standard Deviation 23.08
|
|
Resource Utilization: Distances Traveled
Cycle 2, Hospital to Home, Great Britain (n=24)
|
15.5 kilometers (km)
Standard Deviation 13.12
|
|
Resource Utilization: Distances Traveled
Cycle 2, Hospital to Home, Sweden (n=7)
|
23.9 kilometers (km)
Standard Deviation 23.93
|
|
Resource Utilization: Distances Traveled
Cycle 3, Hospital to Home, Great Britain (n=11)
|
23.8 kilometers (km)
Standard Deviation 16.72
|
|
Resource Utilization: Distances Traveled
Cycle 3, Hospital to Home, Sweden (n=4)
|
17.5 kilometers (km)
Standard Deviation 17.97
|
|
Resource Utilization: Distances Traveled
Cycle 4, Hospital to Home, Great Britain (n=7)
|
11.7 kilometers (km)
Standard Deviation 8.75
|
|
Resource Utilization: Distances Traveled
Cycle 4, Hospital to Home, Sweden (n=2)
|
24.5 kilometers (km)
Standard Deviation 27.58
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to the date of death from any cause (up to Month 6)Population: ITT population: Participants who received at least 1 dose of study drug. Twenty-four (24) participants were censored (alive) at the end of the study.
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).
Outcome measures
| Measure |
Pemetrexed
n=52 Participants
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.
|
|---|---|
|
Overall Survival (OS) at 6 Months
|
73 percentage of participants
Interval 58.1 to 82.8
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle)Population: ITT population: Participants who received at least 1 dose of study drug. Two (2) participants were censored.
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.
Outcome measures
| Measure |
Pemetrexed
n=52 Participants
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.
|
|---|---|
|
Time to Treatment Failure (TTF)
|
3.0 months
Interval 2.3 to 4.2
|
OTHER_PRE_SPECIFIED outcome
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]Population: Safety Population: Participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Pemetrexed
n=52 Participants
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.
|
|---|---|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died
At least 1 TEAE
|
51 participants
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died
At least 1 Serious TEAE
|
21 participants
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died
Death, AE (fell, multiple injuries)
|
1 participants
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died
Death, Study Drug Toxicity (atypical pneumonia)
|
1 participants
|
|
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died
Death, Study Disease
|
26 participants
|
Adverse Events
Pemetrexed
Serious adverse events
| Measure |
Pemetrexed
n=52 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/52 • Number of events 2 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Cardiac disorders
Atrial flutter
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Stomatitis
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Chest discomfort
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Chest pain
|
3.8%
2/52 • Number of events 2 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Device occlusion
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Atypical pneumonia
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Bronchitis
|
1.9%
1/52 • Number of events 2 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Influenza
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Lower respiratory tract infection
|
5.8%
3/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Pneumonia
|
3.8%
2/52 • Number of events 3 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
3/52 • Number of events 3 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Investigations
Blood creatinine increased
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Investigations
Neutrophil count decreased
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/52 • Number of events 2 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Dizziness
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Loss of consciousness
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Sensory loss
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Spinal cord compression
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Renal and urinary disorders
Renal impairment
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
4/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/52 • Number of events 1 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
Other adverse events
| Measure |
Pemetrexed
n=52 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
12/52 • Number of events 14 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Eye disorders
Lacrimation increased
|
11.5%
6/52 • Number of events 6 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
4/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Constipation
|
15.4%
8/52 • Number of events 10 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
3/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
3/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Nausea
|
32.7%
17/52 • Number of events 24 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
4/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
6/52 • Number of events 8 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Chest pain
|
7.7%
4/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Fatigue
|
38.5%
20/52 • Number of events 31 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Influenza like illness
|
7.7%
4/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Oedema peripheral
|
5.8%
3/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Pain
|
5.8%
3/52 • Number of events 3 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
General disorders
Pyrexia
|
9.6%
5/52 • Number of events 7 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Bronchitis
|
5.8%
3/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Lower respiratory tract infection
|
5.8%
3/52 • Number of events 3 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
3/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
4/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Investigations
Blood creatinine increased
|
9.6%
5/52 • Number of events 5 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.3%
9/52 • Number of events 10 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
5/52 • Number of events 8 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.3%
9/52 • Number of events 9 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.7%
4/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Dizziness
|
9.6%
5/52 • Number of events 5 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Dysgeusia
|
5.8%
3/52 • Number of events 3 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Headache
|
15.4%
8/52 • Number of events 11 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Lethargy
|
17.3%
9/52 • Number of events 12 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.8%
3/52 • Number of events 3 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
12/52 • Number of events 12 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.3%
9/52 • Number of events 10 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
3/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.5%
7/52 • Number of events 7 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
4/52 • Number of events 4 • Baseline through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60