Trial Outcomes & Findings for An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed (NCT NCT00497770)
NCT ID: NCT00497770
Last Updated: 2012-05-02
Results Overview
Disease Control Rate \[DCR\] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.
Recruitment status
COMPLETED
Target enrollment
434 participants
Primary outcome timeframe
baseline to measured progressive disease (up to 20 cycles [14 months])
Results posted on
2012-05-02
Participant Flow
Target goals for recruitment were not met due to slow enrollment.
Participant milestones
| Measure |
Caucasian
Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
|
African American
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
304
|
65
|
37
|
28
|
|
Overall Study
COMPLETED
|
304
|
65
|
37
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed
Baseline characteristics by cohort
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
Total
n=434 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
65.64 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
62.74 years
STANDARD_DEVIATION 8.93 • n=7 Participants
|
65.05 years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
63.14 years
STANDARD_DEVIATION 13.29 • n=4 Participants
|
64.99 years
STANDARD_DEVIATION 10.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
235 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
304 participants
n=5 Participants
|
65 participants
n=7 Participants
|
37 participants
n=5 Participants
|
28 participants
n=4 Participants
|
434 participants
n=21 Participants
|
|
Disease Stage
IIIB
|
60 participants
n=5 Participants
|
14 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
90 participants
n=21 Participants
|
|
Disease Stage
IV
|
244 participants
n=5 Participants
|
51 participants
n=7 Participants
|
29 participants
n=5 Participants
|
20 participants
n=4 Participants
|
344 participants
n=21 Participants
|
|
Histology of tumor
Adenocarcinoma
|
191 participants
n=5 Participants
|
44 participants
n=7 Participants
|
33 participants
n=5 Participants
|
25 participants
n=4 Participants
|
293 participants
n=21 Participants
|
|
Histology of tumor
Squamous Cell
|
77 participants
n=5 Participants
|
13 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
Histology of tumor
Other [not adenocarcinoma or squamous cell]
|
36 participants
n=5 Participants
|
8 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
47 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0 - Fully Active
|
58 participants
n=5 Participants
|
15 participants
n=7 Participants
|
12 participants
n=5 Participants
|
8 participants
n=4 Participants
|
93 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1 - Ambulatory, Restricted Strenuous Activity
|
166 participants
n=5 Participants
|
39 participants
n=7 Participants
|
15 participants
n=5 Participants
|
14 participants
n=4 Participants
|
234 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
2 - Ambulatory, No Work Activities
|
53 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
3 - Partially Confined to Bed, Limited Self Care
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Not available
|
19 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
31 participants
n=21 Participants
|
|
Smoking Status
Current
|
83 participants
n=5 Participants
|
21 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
107 participants
n=21 Participants
|
|
Smoking Status
Former
|
196 participants
n=5 Participants
|
42 participants
n=7 Participants
|
13 participants
n=5 Participants
|
18 participants
n=4 Participants
|
269 participants
n=21 Participants
|
|
Smoking Status
Never
|
21 participants
n=5 Participants
|
2 participants
n=7 Participants
|
24 participants
n=5 Participants
|
7 participants
n=4 Participants
|
54 participants
n=21 Participants
|
|
Smoking Status
Not Collected
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Smoking Status
Unknown
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (up to 20 cycles [14 months])Population: Of the 434 participants enrolled, 50 participants had a response status at the end of pemetrexed treatment indicating "Not done/Missing" and were not included in this analysis.
Disease Control Rate \[DCR\] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.
Outcome measures
| Measure |
Caucasian
n=268 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=60 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=30 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=26 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)
|
43.7 percentage of participants
|
45.0 percentage of participants
|
53.33 percentage of participants
|
34.6 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to date of death from any cause (up to 20 cycles [14 months])Population: All participants enrolled in the study.
Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Overall Survival
|
6.77 months
95% Confidence Interval 0.38 • Interval 5.68 to 7.92
|
6.90 months
95% Confidence Interval 1.34 • Interval 4.53 to 8.94
|
16.0 months
95% Confidence Interval 1.06 • Interval 5.75 to 16.0
|
5.35 months
95% Confidence Interval 0.91 • Interval 2.04 to 12.0
|
SECONDARY outcome
Timeframe: baseline to measured progressive disease or death (up to 20 cycles [14 months])Population: All participants enrolled in the study.
Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Progression Free Survival
|
2.66 months
Interval 2.4 to 3.35
|
2.99 months
Interval 2.33 to 4.73
|
5.08 months
Interval 2.5 to 11.1
|
2.20 months
Interval 1.81 to 3.71
|
SECONDARY outcome
Timeframe: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])Population: All participants enrolled in the study.
The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Without Help-end of treatment
|
25.3 percentage of participants
|
26.2 percentage of participants
|
37.8 percentage of participants
|
14.3 percentage of participants
|
|
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Unable-end of treatment
|
4.3 percentage of participants
|
9.2 percentage of participants
|
0.0 percentage of participants
|
3.6 percentage of participants
|
|
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Not Done (missing)-end of treatment
|
60.9 percentage of participants
|
50.8 percentage of participants
|
54.1 percentage of participants
|
71.4 percentage of participants
|
|
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Without Help-baseline
|
63.2 percentage of participants
|
63.1 percentage of participants
|
70.3 percentage of participants
|
71.4 percentage of participants
|
|
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Some Help-baseline
|
24.3 percentage of participants
|
23.1 percentage of participants
|
13.5 percentage of participants
|
10.7 percentage of participants
|
|
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Unable-baseline
|
4.9 percentage of participants
|
9.2 percentage of participants
|
10.8 percentage of participants
|
17.9 percentage of participants
|
|
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Not Done (missing)-baseline
|
7.6 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Some Help-end of treatment
|
9.5 percentage of participants
|
13.8 percentage of participants
|
8.1 percentage of participants
|
10.7 percentage of participants
|
SECONDARY outcome
Timeframe: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])Population: All participants enrolled in the study.
The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Unable-end of treatment
|
1.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Not Done (missing)-end of treatment
|
60.9 percentage of participants
|
50.8 percentage of participants
|
54.1 percentage of participants
|
71.4 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Without Help-baseline
|
62.2 percentage of participants
|
63.1 percentage of participants
|
62.2 percentage of participants
|
50.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Some Help-baseline
|
29.6 percentage of participants
|
32.3 percentage of participants
|
29.7 percentage of participants
|
50.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Unable-baseline
|
0.7 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Not Done (missing)-baseline
|
7.6 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Without Help-end of treatment
|
23.4 percentage of participants
|
29.2 percentage of participants
|
45.9 percentage of participants
|
21.4 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Some Help-end of treatment
|
14.8 percentage of participants
|
20.0 percentage of participants
|
0.0 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])Population: All participants enrolled in the study.
The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Unable-end of treatment
|
1.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Without Help-baseline
|
78.6 percentage of participants
|
67.7 percentage of participants
|
83.8 percentage of participants
|
71.4 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Some Help-baseline
|
11.5 percentage of participants
|
26.2 percentage of participants
|
8.1 percentage of participants
|
17.9 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Unable-baseline
|
2.3 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
10.7 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Not Done (missing)-baseline
|
7.6 percentage of participants
|
6.2 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Without Help-end of treatment
|
31.9 percentage of participants
|
38.5 percentage of participants
|
45.9 percentage of participants
|
25.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Some Help-end of treatment
|
5.6 percentage of participants
|
10.8 percentage of participants
|
0.0 percentage of participants
|
3.6 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Not Done (missing)-end of treatment
|
61.2 percentage of participants
|
50.8 percentage of participants
|
54.1 percentage of participants
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])Population: All participants enrolled in the study.
The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Some Help-end of treatment
|
15.5 percentage of participants
|
18.5 percentage of participants
|
16.2 percentage of participants
|
14.3 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Without Help-baseline
|
44.1 percentage of participants
|
44.6 percentage of participants
|
54.1 percentage of participants
|
42.9 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Some Help-baseline
|
38.2 percentage of participants
|
33.8 percentage of participants
|
32.4 percentage of participants
|
32.1 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Unable-baseline
|
9.5 percentage of participants
|
16.9 percentage of participants
|
8.1 percentage of participants
|
25.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Not Done (missing)-baseline
|
8.2 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Without Help-end of treatment
|
15.8 percentage of participants
|
21.5 percentage of participants
|
27.0 percentage of participants
|
10.7 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Unable-end of treatment
|
7.2 percentage of participants
|
9.2 percentage of participants
|
2.7 percentage of participants
|
3.6 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Not Done (missing)-end of treatment
|
61.5 percentage of participants
|
50.8 percentage of participants
|
54.1 percentage of participants
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])Population: All participants enrolled in the study.
The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Unable-baseline
|
0.7 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
7.1 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Without Help-baseline
|
79.3 percentage of participants
|
73.8 percentage of participants
|
86.5 percentage of participants
|
85.7 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Some Help-baseline
|
12.8 percentage of participants
|
21.5 percentage of participants
|
5.4 percentage of participants
|
7.1 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Not Done (missing)-baseline
|
7.2 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Without Help-end of treatment
|
30.9 percentage of participants
|
36.9 percentage of participants
|
45.9 percentage of participants
|
25.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Some Help-end of treatment
|
7.6 percentage of participants
|
10.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Unable-end of treatment
|
0.7 percentage of participants
|
1.5 percentage of participants
|
0.0 percentage of participants
|
3.6 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Not Done (missing)-end of treatment
|
7.2 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])Population: All participants enrolled in the study.
The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Some Help-end of treatment
|
14.1 percentage of participants
|
21.5 percentage of participants
|
5.4 percentage of participants
|
14.3 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Unable-end of treatment
|
4.6 percentage of participants
|
3.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Without Help-baseline
|
57.2 percentage of participants
|
58.5 percentage of participants
|
59.5 percentage of participants
|
50.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Some Help-baseline
|
29.9 percentage of participants
|
32.3 percentage of participants
|
29.7 percentage of participants
|
35.7 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Unable-baseline
|
5.6 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
14.3 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Not Done (missing)-baseline
|
7.2 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Without Help-end of treatment
|
20.1 percentage of participants
|
24.6 percentage of participants
|
40.5 percentage of participants
|
14.3 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Not Done (missing)-end of treatment
|
61.2 percentage of participants
|
50.8 percentage of participants
|
54.1 percentage of participants
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])Population: All participants enrolled in the study.
The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Outcome measures
| Measure |
Caucasian
n=304 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Not Done (missing)-baseline
|
7.9 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
3.6 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Without Help-end of treatment
|
34.9 percentage of participants
|
41.5 percentage of participants
|
45.9 percentage of participants
|
25.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Some Help-end of treatment
|
3.0 percentage of participants
|
7.7 percentage of participants
|
0.0 percentage of participants
|
3.6 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Unable-end of treatment
|
1.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Without Help-baseline
|
86.5 percentage of participants
|
90.8 percentage of participants
|
86.5 percentage of participants
|
92.9 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Some Help-baseline
|
5.6 percentage of participants
|
4.6 percentage of participants
|
5.4 percentage of participants
|
3.6 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Unable-baseline
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
0.0 percentage of participants
|
|
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Not Done (missing)-end of treatment
|
60.9 percentage of participants
|
50.8 percentage of participants
|
54.1 percentage of participants
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (up to 20 cycles [14 months])Population: The number of participants who had measurements for the subscale at those time points.
The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment.
Outcome measures
| Measure |
Caucasian
n=282 Participants
Caucasian participants receiving pemetrexed for 2nd line NSCLC
|
African American
n=65 Participants
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=35 Participants
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 Participants
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Pain-baseline (n=281, 62, 35, 28)
|
3.37 participants
Standard Deviation 3.27
|
3.73 participants
Standard Deviation 3.63
|
3.89 participants
Standard Deviation 3.32
|
3.75 participants
Standard Deviation 3.95
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Sleep-baseline (n=280, 62, 34, 28)
|
3.24 participants
Standard Deviation 3.07
|
3.66 participants
Standard Deviation 3.59
|
3.21 participants
Standard Deviation 3.27
|
4.11 participants
Standard Deviation 2.97
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Shortness of Breath-EOT (n=118, 32, 17, 8)
|
3.76 participants
Standard Deviation 3.12
|
5.06 participants
Standard Deviation 3.32
|
1.82 participants
Standard Deviation 2.53
|
2.88 participants
Standard Deviation 3.44
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Dry Mouth-baseline (n=279, 62, 35, 28)
|
2.89 participants
Standard Deviation 2.98
|
2.73 participants
Standard Deviation 3.06
|
3.29 participants
Standard Deviation 3.19
|
3.36 participants
Standard Deviation 3.41
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Dry Mouth-EOT (n=119, 32, 17, 8)
|
2.91 participants
Standard Deviation 2.99
|
2.44 participants
Standard Deviation 3.04
|
2.71 participants
Standard Deviation 2.78
|
2.25 participants
Standard Deviation 2.96
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Sadness-baseline (n=278, 61, 35, 28)
|
2.40 participants
Standard Deviation 2.81
|
2.57 participants
Standard Deviation 3.23
|
2.74 participants
Standard Deviation 2.81
|
4.32 participants
Standard Deviation 3.51
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Vomiting-baseline (n=282, 62, 35, 28)
|
0.74 participants
Standard Deviation 1.85
|
0.97 participants
Standard Deviation 2.06
|
0.66 participants
Standard Deviation 1.35
|
1.25 participants
Standard Deviation 2.59
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Cough-EOT (n=119, 31, 16, 8)
|
2.50 participants
Standard Deviation 2.63
|
3.94 participants
Standard Deviation 3.21
|
1.63 participants
Standard Deviation 1.96
|
3.13 participants
Standard Deviation 3.60
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Constipation-baseline (n=281, 62 34, 28)
|
2.47 participants
Standard Deviation 3.11
|
2.37 participants
Standard Deviation 3.17
|
2.79 participants
Standard Deviation 3.22
|
3.54 participants
Standard Deviation 3.86
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Constipation-EOT (n=119, 32 17, 8)
|
2.55 participants
Standard Deviation 2.85
|
2.88 participants
Standard Deviation 3.50
|
2.47 participants
Standard Deviation 3.10
|
1.50 participants
Standard Deviation 1.77
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
General Activity-baseline (n=280, 62, 35, 28)
|
3.71 participants
Standard Deviation 3.13
|
3.56 participants
Standard Deviation 3.38
|
2.46 participants
Standard Deviation 2.69
|
4.46 participants
Standard Deviation 3.89
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
General Activity-EOT (n=119,32,16,8)
|
3.89 participants
Standard Deviation 3.04
|
4.53 participants
Standard Deviation 3.65
|
2.88 participants
Standard Deviation 2.70
|
3.63 participants
Standard Deviation 3.50
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Enjoyment-baseline (n=282, 61, 35, 28)
|
3.33 participants
Standard Deviation 3.26
|
3.51 participants
Standard Deviation 3.38
|
2.83 participants
Standard Deviation 2.81
|
4.39 participants
Standard Deviation 4.04
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Enjoyment-EOT (n=119, 32, 16, 8)
|
3.39 participants
Standard Deviation 3.16
|
4.00 participants
Standard Deviation 3.77
|
2.81 participants
Standard Deviation 2.54
|
4.00 participants
Standard Deviation 4.75
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Work-baseline (n=278, 62, 35, 28)
|
3.72 participants
Standard Deviation 3.32
|
4.23 participants
Standard Deviation 3.86
|
2.51 participants
Standard Deviation 2.45
|
4.86 participants
Standard Deviation 3.95
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Cough-baseline (n=281, 61, 35, 28)
|
2.89 participants
Standard Deviation 2.92
|
2.98 participants
Standard Deviation 2.91
|
2.63 participants
Standard Deviation 2.77
|
2.61 participants
Standard Deviation 3.44
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Pain-end of treatment (EOT) (n=118, 31, 17, 8)
|
3.52 participants
Standard Deviation 3.25
|
5.16 participants
Standard Deviation 3.69
|
1.82 participants
Standard Deviation 2.30
|
1.88 participants
Standard Deviation 2.17
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Fatigue-baseline (n=279, 62, 35, 28)
|
4.63 participants
Standard Deviation 2.83
|
4.58 participants
Standard Deviation 3.11
|
4.14 participants
Standard Deviation 2.37
|
5.04 participants
Standard Deviation 3.28
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Fatigue-EOT (n=119, 32, 17, 8)
|
4.98 participants
Standard Deviation 2.72
|
4.91 participants
Standard Deviation 3.30
|
3.71 participants
Standard Deviation 2.76
|
4.00 participants
Standard Deviation 3.74
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Nausea-baseline (n=280, 62, 35, 28)
|
1.39 participants
Standard Deviation 2.54
|
1.55 participants
Standard Deviation 2.60
|
1.34 participants
Standard Deviation 2.18
|
2.43 participants
Standard Deviation 3.49
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Nausea-EOT (n=118, 30, 17, 8)
|
1.76 participants
Standard Deviation 2.67
|
1.67 participants
Standard Deviation 2.66
|
1.18 participants
Standard Deviation 1.33
|
0.75 participants
Standard Deviation 1.39
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Sleep-EOT (n=118, 31, 17, 8)
|
3.58 participants
Standard Deviation 2.97
|
4.16 participants
Standard Deviation 3.40
|
2.94 participants
Standard Deviation 3.27
|
3.13 participants
Standard Deviation 3.80
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Distress (Upset)-baseline (n=277, 62, 34, 28)
|
2.89 participants
Standard Deviation 3.01
|
3.00 participants
Standard Deviation 3.23
|
2.76 participants
Standard Deviation 2.71
|
4.07 participants
Standard Deviation 3.57
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Distress (Upset)-EOT (n=119, 32, 17, 8)
|
3.05 participants
Standard Deviation 2.94
|
3.22 participants
Standard Deviation 3.58
|
2.41 participants
Standard Deviation 1.97
|
3.63 participants
Standard Deviation 4.10
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Shortness of Breath-baseline (n=282, 61, 35, 28)
|
3.58 participants
Standard Deviation 3.06
|
3.70 participants
Standard Deviation 3.12
|
2.69 participants
Standard Deviation 3.00
|
4.29 participants
Standard Deviation 3.40
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Memory-baseline (n=278, 62, 35, 28)
|
2.40 participants
Standard Deviation 2.56
|
2.71 participants
Standard Deviation 2.56
|
2.09 participants
Standard Deviation 2.31
|
2.50 participants
Standard Deviation 2.77
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Memory-EOT (n=119, 32, 17, 8)
|
2.47 participants
Standard Deviation 2.56
|
2.81 participants
Standard Deviation 3.06
|
1.82 participants
Standard Deviation 2.38
|
0.63 participants
Standard Deviation 1.19
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Appetite-baseline (n=281, 62, 35, 28)
|
2.84 participants
Standard Deviation 3.02
|
3.11 participants
Standard Deviation 3.38
|
3.37 participants
Standard Deviation 2.73
|
4.86 participants
Standard Deviation 3.30
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Appetite-EOT (n=119, 32, 16, 8)
|
2.87 participants
Standard Deviation 3.01
|
4.72 participants
Standard Deviation 4.03
|
2.38 participants
Standard Deviation 2.58
|
4.00 participants
Standard Deviation 3.74
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Drowsy-baseline (n=280, 65, 32, 28)
|
3.20 participants
Standard Deviation 2.79
|
3.32 participants
Standard Deviation 2.97
|
2.63 participants
Standard Deviation 2.38
|
4.36 participants
Standard Deviation 3.18
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Drowsy-EOT (n=119, 32, 17, 8)
|
3.30 participants
Standard Deviation 2.84
|
3.69 participants
Standard Deviation 3.56
|
1.59 participants
Standard Deviation 1.84
|
3.13 participants
Standard Deviation 3.18
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Mood-baseline (n=279, 61, 34, 28)
|
2.85 participants
Standard Deviation 2.96
|
3.11 participants
Standard Deviation 3.07
|
2.44 participants
Standard Deviation 2.78
|
3.86 participants
Standard Deviation 3.76
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Sadness-EOT (n=119, 32, 17, 8)
|
2.39 participants
Standard Deviation 2.83
|
2.81 participants
Standard Deviation 3.59
|
2.06 participants
Standard Deviation 2.08
|
3.88 participants
Standard Deviation 3.72
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Mood-EOT (n=119, 32, 16, 8)
|
2.07 participants
Standard Deviation 2.24
|
1.88 participants
Standard Deviation 2.23
|
1.89 participants
Standard Deviation 2.26
|
1.86 participants
Standard Deviation 2.97
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Work-EOT (n=118, 32, 16, 8)
|
4.05 participants
Standard Deviation 3.47
|
4.63 participants
Standard Deviation 3.72
|
2.81 participants
Standard Deviation 2.48
|
4.25 participants
Standard Deviation 3.77
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Relationships with Others-baseline(n=282,61,35,28)
|
1.83 participants
Standard Deviation 2.53
|
2.41 participants
Standard Deviation 3.07
|
2.00 participants
Standard Deviation 2.52
|
3.07 participants
Standard Deviation 3.57
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Relationships with Others-EOT (n=118, 31, 16, 8)
|
2.17 participants
Standard Deviation 2.76
|
2.71 participants
Standard Deviation 3.13
|
1.50 participants
Standard Deviation 2.31
|
2.75 participants
Standard Deviation 3.96
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Walking-baseline (n=280, 62, 35, 28)
|
3.84 participants
Standard Deviation 3.15
|
4.00 participants
Standard Deviation 3.39
|
2.80 participants
Standard Deviation 2.75
|
4.21 participants
Standard Deviation 3.35
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Walking-EOT (n=119, 32, 16, 8)
|
4.12 participants
Standard Deviation 3.32
|
4.44 participants
Standard Deviation 3.56
|
2.94 participants
Standard Deviation 2.54
|
4.00 participants
Standard Deviation 3.82
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Vomiting-EOT (n=119, 32, 17, 8)
|
0.97 participants
Standard Deviation 1.49
|
1.06 participants
Standard Deviation 2.03
|
0.88 participants
Standard Deviation 2.03
|
0.13 participants
Standard Deviation 0.35
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Numbness-baseline (n=280, 61, 33, 28)
|
2.42 participants
Standard Deviation 2.99
|
3.34 participants
Standard Deviation 3.26
|
2.76 participants
Standard Deviation 2.72
|
2.39 participants
Standard Deviation 3.40
|
|
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Numbness-EOT (n=119, 32, 17, 8)
|
2.34 participants
Standard Deviation 2.64
|
3.84 participants
Standard Deviation 3.47
|
2.47 participants
Standard Deviation 2.15
|
0.63 participants
Standard Deviation 1.77
|
Adverse Events
Caucasian
Serious events: 21 serious events
Other events: 256 other events
Deaths: 0 deaths
African American
Serious events: 4 serious events
Other events: 54 other events
Deaths: 0 deaths
Asian American
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Hispanic
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caucasian
n=304 participants at risk
Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
|
African American
n=65 participants at risk
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 participants at risk
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 participants at risk
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
8/304 • Number of events 10
|
1.5%
1/65 • Number of events 1
|
0.00%
0/37
|
3.6%
1/28 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
7/304 • Number of events 8
|
1.5%
1/65 • Number of events 1
|
0.00%
0/37
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diarrhea
|
0.33%
1/304 • Number of events 1
|
0.00%
0/65
|
0.00%
0/37
|
0.00%
0/28
|
|
General disorders
Fatigue
|
3.6%
11/304 • Number of events 12
|
4.6%
3/65 • Number of events 3
|
2.7%
1/37 • Number of events 1
|
0.00%
0/28
|
|
General disorders
Mucositis
|
0.00%
0/304
|
1.5%
1/65 • Number of events 1
|
0.00%
0/37
|
0.00%
0/28
|
Other adverse events
| Measure |
Caucasian
n=304 participants at risk
Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
|
African American
n=65 participants at risk
African American participants receiving pemetrexed for 2nd line NSCLC
|
Asian American
n=37 participants at risk
Asian American participants receiving pemetrexed for 2nd line NSCLC
|
Hispanic
n=28 participants at risk
Hispanic participants receiving pemetrexed for 2nd line NSCLC
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
18.1%
55/304 • Number of events 76
|
13.8%
9/65 • Number of events 13
|
5.4%
2/37 • Number of events 3
|
10.7%
3/28 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.1%
55/304 • Number of events 84
|
9.2%
6/65 • Number of events 10
|
5.4%
2/37 • Number of events 4
|
14.3%
4/28 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
14.8%
45/304 • Number of events 59
|
7.7%
5/65 • Number of events 6
|
5.4%
2/37 • Number of events 2
|
7.1%
2/28 • Number of events 4
|
|
General disorders
Fatigue
|
79.6%
242/304 • Number of events 516
|
80.0%
52/65 • Number of events 108
|
73.0%
27/37 • Number of events 57
|
75.0%
21/28 • Number of events 37
|
|
General disorders
Mucositis
|
7.2%
22/304 • Number of events 25
|
13.8%
9/65 • Number of events 12
|
5.4%
2/37 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.1%
55/304 • Number of events 79
|
7.7%
5/65 • Number of events 7
|
5.4%
2/37 • Number of events 3
|
10.7%
3/28 • Number of events 6
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60