Trial Outcomes & Findings for A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (NCT NCT01900652)
NCT ID: NCT01900652
Last Updated: 2019-09-18
Results Overview
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab 750mg
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
28
|
|
Overall Study
Post-Erlotinib Progression Tumor Sample
|
66
|
23
|
|
Overall Study
COMPLETED
|
75
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab 750mg
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
0
|
|
Overall Study
Consent withdrawn by subject
|
1
|
1
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
Baseline characteristics by cohort
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=83 Participants
750 milligram (mg) Emibetuzumab (LY2875358) flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=28 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 0
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 1
|
60 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 2
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Pathological Diagnosis
Lung Adenocarcinoma
|
77 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Pathological Diagnosis
Squamous Cell Carcinoma
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Pathological Diagnosis
Large Cell Carcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Pathological Diagnosis
Other Subtypes of Lung Cancer
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)Population: All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=66 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=23 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
n=53 Participants
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
n=21 Participants
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
|
3.0 percentage of participants
Interval 0.4 to 10.5
|
4.3 percentage of participants
Interval 0.1 to 21.9
|
3.8 percentage of participants
Interval 0.5 to 13.0
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
SECONDARY outcome
Timeframe: Baseline to Objective Disease Progression or Death (Up to 24 Months)Population: All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.
PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=66 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=23 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
3.3 Months
Interval 1.7 to 4.2
|
1.6 Months
Interval 1.2 to 3.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Objective Disease Progression (Up to 24 Months)Population: All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=66 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=23 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Time to Progressive Disease
|
3.8 months
Interval 2.7 to 4.7
|
1.6 months
Interval 1.4 to 3.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)Population: Zero participants analyzed.CTS data was not collected for analysis due to N=0 CR and N=3 PR.
Zero participants analyzed. CTS data was not collected for analysis due to N=0 CR and N=3 PR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)Population: All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.
Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal \[ULN\]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)\*100.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=66 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=23 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
n=53 Participants
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
n=21 Participants
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
|
50 percentage of participants
Interval 37.4 to 62.6
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
47.2 percentage of participants
Interval 33.3 to 61.4
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
SECONDARY outcome
Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)Population: Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.
Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Death Due to Any Cause (Up to 24 Months)Population: All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.
OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=66 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=23 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
9.2 Months
Interval 6.7 to 12.0
|
8.2 Months
Interval 3.7 to 12.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)Population: All randomized participants with EORTC QLQ-C30 values at baseline.
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=83 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=28 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
n=74 Participants
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
QoL
|
-4.0 units on a scale
Standard Deviation 18.3
|
-21.9 units on a scale
Standard Deviation 18.9
|
-10.2 units on a scale
Standard Deviation 22.3
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Physical
|
-11.4 units on a scale
Standard Deviation 25.8
|
-22.9 units on a scale
Standard Deviation 30.2
|
-19.0 units on a scale
Standard Deviation 27.4
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Emotional
|
1.7 units on a scale
Standard Deviation 29.9
|
-13.5 units on a scale
Standard Deviation 19.9
|
-6.1 units on a scale
Standard Deviation 29.7
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Cognitive
|
-3.3 units on a scale
Standard Deviation 31.2
|
-10.4 units on a scale
Standard Deviation 25.1
|
-9.8 units on a scale
Standard Deviation 29.4
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Constipation
|
3.8 units on a scale
Standard Deviation 31.7
|
33.3 units on a scale
Standard Deviation 50.4
|
17.4 units on a scale
Standard Deviation 38.8
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Diarrhea
|
-5.3 units on a scale
Standard Deviation 41.6
|
4.2 units on a scale
Standard Deviation 48.6
|
-1.5 units on a scale
Standard Deviation 43.0
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Role
|
-7.7 units on a scale
Standard Deviation 42.0
|
-35.4 units on a scale
Standard Deviation 35.0
|
-21.0 units on a scale
Standard Deviation 39.3
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Social
|
-12.5 units on a scale
Standard Deviation 29.6
|
-16.7 units on a scale
Standard Deviation 39.8
|
-19.8 units on a scale
Standard Deviation 29.2
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Fatigue
|
8.5 units on a scale
Standard Deviation 23.6
|
31.9 units on a scale
Standard Deviation 33.8
|
16.9 units on a scale
Standard Deviation 30.7
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Nausea/vomiting
|
-1.3 units on a scale
Standard Deviation 31.2
|
0 units on a scale
Standard Deviation 0
|
0.7 units on a scale
Standard Deviation 39.1
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Pain
|
1.9 units on a scale
Standard Deviation 26.0
|
14.6 units on a scale
Standard Deviation 24.3
|
2.2 units on a scale
Standard Deviation 28.6
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Dyspnea
|
9.0 units on a scale
Standard Deviation 32.1
|
29.2 units on a scale
Standard Deviation 37.5
|
14.5 units on a scale
Standard Deviation 38.7
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Insomnia
|
-14.1 units on a scale
Standard Deviation 39.1
|
-16.7 units on a scale
Standard Deviation 23.6
|
-15.9 units on a scale
Standard Deviation 43.7
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Appetite Loss
|
6.4 units on a scale
Standard Deviation 36.5
|
29.2 units on a scale
Standard Deviation 41.5
|
15.9 units on a scale
Standard Deviation 42.5
|
—
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Finance
|
-6.7 units on a scale
Standard Deviation 23.6
|
8.3 units on a scale
Standard Deviation 42.7
|
3.0 units on a scale
Standard Deviation 30.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)Population: All randomized participants with EORTC QLQ-LC13 values at baseline.
The EORTC lung module QLQ-LC13 comprises 13 items consisting of one multi-item scale to assess dyspnea and a series of single-item measures assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. The higher scores represent a greater degree of symptoms.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=83 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=28 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
n=74 Participants
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Alopecia
|
-5.3 units on a scale
Standard Deviation 34.3
|
0 units on a scale
Standard Deviation 0
|
4.8 units on a scale
Standard Deviation 19.1
|
—
|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Pain in Shoulder or Arm
|
-2.6 units on a scale
Standard Deviation 28.2
|
0 units on a scale
Standard Deviation 0
|
3.2 units on a scale
Standard Deviation 25.6
|
—
|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Coughing
|
14.1 units on a scale
Standard Deviation 35.5
|
16.7 units on a scale
Standard Deviation 35.0
|
17.5 units on a scale
Standard Deviation 35.9
|
—
|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Hemoptysis
|
2.6 units on a scale
Standard Deviation 9.1
|
0 units on a scale
Standard Deviation 0
|
3.2 units on a scale
Standard Deviation 10.0
|
—
|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Sore Mouth
|
7.7 units on a scale
Standard Deviation 25.5
|
5.6 units on a scale
Standard Deviation 13.6
|
12.7 units on a scale
Standard Deviation 22.3
|
—
|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Dysphagia
|
7.7 units on a scale
Standard Deviation 25.5
|
5.6 units on a scale
Standard Deviation 13.6
|
9.5 units on a scale
Standard Deviation 26.1
|
—
|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Peripheral Neuropathy
|
-5.1 units on a scale
Standard Deviation 22.5
|
5.6 units on a scale
Standard Deviation 13.6
|
-4.8 units on a scale
Standard Deviation 21.8
|
—
|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Pain in Chest
|
-1.3 units on a scale
Standard Deviation 11.7
|
5.6 units on a scale
Standard Deviation 13.6
|
1.7 units on a scale
Standard Deviation 13.1
|
—
|
|
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Pain in Other Parts
|
8.0 units on a scale
Standard Deviation 30.9
|
16.7 units on a scale
Standard Deviation 45.9
|
3.3 units on a scale
Standard Deviation 32.3
|
—
|
SECONDARY outcome
Timeframe: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)Population: All randomized participants with EQ-5D values at baseline.
The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status. Additionally, participants will indicate their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=78 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=22 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
n=64 Participants
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
Visual Analog Scale
|
-8.3 units on a scale
Standard Deviation 18.0
|
-12.5 units on a scale
Standard Deviation 21.7
|
-11.8 units on a scale
Standard Deviation 19.4
|
—
|
|
Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
Index Score
|
-0.1 units on a scale
Standard Deviation 0.3
|
-0.2 units on a scale
Standard Deviation 0.3
|
-0.1 units on a scale
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of InfusionPopulation: All participants who received Emibetuzumab on Cycle 1, Day 1, and contributed samples for analysis.
AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=19 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab
|
31400 Microgram*hour/milliliter (ug*hr/mL)
Geometric Coefficient of Variation 75
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 30-Day Follow-Up (Up to 24 Months)Population: All participants who received at least one dose of study drug and have sufficient Anti-Emibetuzumab Antibody sample for the analysis.
Outcome measures
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=44 Participants
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=17 Participants
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
MET-High Analysis Population (Emibetuzumab + Erlotinib)
Participants in the Emibetuzumab + Erlotinib treatment arm with MET-High expression status based on their post-erlotinib progression NSCLC tumor sample.
|
MET-High Analysis Population (Emibetuzumab)
Participants in the Emibetuzumab treatment arm with MET-High expression status based on their post- erlotinib progression NSCLC tumor sample.
|
|---|---|---|---|---|
|
Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response
|
0 participants
|
0 participants
|
—
|
—
|
Adverse Events
Arm A: Emibetuzumab Plus Erlotinib
Serious events: 36 serious events
Other events: 82 other events
Deaths: 0 deaths
Arm B: Emibetuzumab
Serious events: 11 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=83 participants at risk
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=28 participants at risk
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
|---|---|---|
|
Nervous system disorders
Cerebral ischaemia
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Nervous system disorders
Seizure
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
4/83 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.4%
2/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.0%
5/83 • Number of events 6 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.2%
6/83 • Number of events 6 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.2%
1/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Vascular disorders
Embolism
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
3/83 • Number of events 4 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Chest pain
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
General physical health deterioration
|
3.6%
3/83 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Oedema peripheral
|
2.4%
2/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Pain
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Pyrexia
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Bronchitis
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Gastroenteritis viral
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Rash pustular
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Sepsis
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Staphylococcal sepsis
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Tracheobronchitis
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
Other adverse events
| Measure |
Arm A: Emibetuzumab Plus Erlotinib
n=83 participants at risk
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
|
Arm B: Emibetuzumab
n=28 participants at risk
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
11/83 • Number of events 16 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
10.7%
3/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Eye disorders
Vision blurred
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
2/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
10.7%
3/28 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Constipation
|
21.7%
18/83 • Number of events 21 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
28.6%
8/28 • Number of events 8 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
25.3%
21/83 • Number of events 36 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
25.0%
7/28 • Number of events 9 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.8%
4/83 • Number of events 6 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Nausea
|
32.5%
27/83 • Number of events 32 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
25.0%
7/28 • Number of events 7 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Stomatitis
|
10.8%
9/83 • Number of events 11 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Gastrointestinal disorders
Vomiting
|
19.3%
16/83 • Number of events 24 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
21.4%
6/28 • Number of events 8 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Asthenia
|
10.8%
9/83 • Number of events 19 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
17.9%
5/28 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Axillary pain
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
10.7%
3/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Chills
|
2.4%
2/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Fatigue
|
48.2%
40/83 • Number of events 59 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
39.3%
11/28 • Number of events 15 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Non-cardiac chest pain
|
6.0%
5/83 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Oedema peripheral
|
36.1%
30/83 • Number of events 42 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
32.1%
9/28 • Number of events 15 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Pain
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
General disorders
Pyrexia
|
4.8%
4/83 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
14.3%
4/28 • Number of events 4 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Paronychia
|
13.3%
11/83 • Number of events 18 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Infections and infestations
Urinary tract infection
|
7.2%
6/83 • Number of events 10 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Injury, poisoning and procedural complications
Wound
|
2.4%
2/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.2%
1/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Investigations
Aspartate aminotransferase increased
|
7.2%
6/83 • Number of events 8 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
7.2%
6/83 • Number of events 7 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.1%
25/83 • Number of events 27 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
14.3%
4/28 • Number of events 4 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
15.7%
13/83 • Number of events 25 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.4%
7/83 • Number of events 7 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
8/83 • Number of events 13 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
8/83 • Number of events 8 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.2%
1/83 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.4%
7/83 • Number of events 7 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/83 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
10.7%
3/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.6%
3/83 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
10.7%
3/28 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.4%
7/83 • Number of events 9 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.4%
7/83 • Number of events 10 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
14.3%
4/28 • Number of events 4 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Nervous system disorders
Dizziness
|
6.0%
5/83 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
3.6%
1/28 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Nervous system disorders
Headache
|
6.0%
5/83 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
10.7%
3/28 • Number of events 4 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Psychiatric disorders
Insomnia
|
8.4%
7/83 • Number of events 7 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.5%
17/83 • Number of events 21 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
28.6%
8/28 • Number of events 8 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.5%
22/83 • Number of events 30 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
28.6%
8/28 • Number of events 11 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/83 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
4/83 • Number of events 8 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
10.7%
3/28 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.0%
5/83 • Number of events 5 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.0%
5/83 • Number of events 6 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
18.1%
15/83 • Number of events 23 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.6%
8/83 • Number of events 8 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
1/83 • Number of events 1 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
3/83 • Number of events 3 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
7.1%
2/28 • Number of events 2 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.8%
9/83 • Number of events 24 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.2%
6/83 • Number of events 8 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
0.00%
0/28 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
|
Vascular disorders
Deep vein thrombosis
|
8.4%
7/83 • Number of events 7 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
14.3%
4/28 • Number of events 4 • Through study completion and the 30-day post-discontinuation follow-up period (up to 24 months).
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60