Trial Outcomes & Findings for A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (NCT NCT05513703)
NCT ID: NCT05513703
Last Updated: 2025-10-24
Results Overview
ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 as assessed by ICR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to approximately 1.5 years
Results posted on
2025-10-24
Participant Flow
A total of 9 participants were enrolled and received at least 1 dose of study drug.
Participant milestones
| Measure |
Telisotuzumab Vedotin
Participants received telisotuzumab vedotin by intravenous (IV) infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Telisotuzumab Vedotin
Participants received telisotuzumab vedotin by intravenous (IV) infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Study terminated by sponsor
|
5
|
Baseline Characteristics
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Telisotuzumab Vedotin
n=9 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.
ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 as assessed by ICR.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=9 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR)
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall number of participants analyzed" represents participants evaluable for this outcome measure with CR or PR.
DoR was defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=3 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Duration of Response (DoR)
|
8.5 months
Interval 2.5 to
Not reached due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.
DCR was defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=9 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Disease Control Rate (DCR)
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.
PFS was defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=9 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Progression Free Survival (PFS) Per ICR
|
4.0 months
Interval 0.9 to
Not reached due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.
OS was defined as the time from participant's first dose of study drug to the event of death from any cause.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=9 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Overall Survival (OS)
|
17.5 months
Interval 0.9 to
Not reached due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
The cough item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=8 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 2 Day 1
|
-8.33 score on a scale
Standard Deviation 15.430
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 3 Day 1
|
-11.11 score on a scale
Standard Deviation 34.427
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 4 Day 1
|
-5.56 score on a scale
Standard Deviation 13.608
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 5 Day 1
|
-11.11 score on a scale
Standard Deviation 17.213
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 6 Day 1
|
-13.33 score on a scale
Standard Deviation 29.814
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 7 Day 1
|
-26.67 score on a scale
Standard Deviation 27.889
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 8 Day 1
|
-25.00 score on a scale
Standard Deviation 31.914
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 9 Day 1
|
-6.67 score on a scale
Standard Deviation 14.907
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 10 Day 1
|
-13.33 score on a scale
Standard Deviation 18.257
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 11 Day 1
|
-8.33 score on a scale
Standard Deviation 16.667
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 12 Day 1
|
-16.67 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 13 Day 1
|
-50.00 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 14 Day 1
|
-33.33 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 15 Day 1
|
-16.67 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 16 Day 1
|
-33.33 score on a scale
Standard Deviation 47.140
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 17 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 18 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 19 Day 1
|
-50.00 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 20 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 21 Day 1
|
-33.33 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 22 Day 1
|
-50.00 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 23 Day 1
|
-33.33 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 24 Day 1
|
-33.33 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 25 Day 1
|
-50.00 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 26 Day 1
|
-33.33 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 28 Day 1
|
-50.00 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 30 Day 1
|
-33.33 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
Cycle 32 Day 1
|
-33.33 score on a scale
Standard Deviation 47.140
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
The pain in chest item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=8 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 21 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 22 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 2 Day 1
|
4.17 score on a scale
Standard Deviation 27.817
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 3 Day 1
|
-5.56 score on a scale
Standard Deviation 13.608
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 4 Day 1
|
5.56 score on a scale
Standard Deviation 13.608
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 5 Day 1
|
16.67 score on a scale
Standard Deviation 40.825
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 6 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 7 Day 1
|
-6.67 score on a scale
Standard Deviation 14.907
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 8 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 9 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 10 Day 1
|
0.00 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 11 Day 1
|
8.33 score on a scale
Standard Deviation 16.667
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 12 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 13 Day 1
|
-16.67 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 14 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 15 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 16 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 17 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 18 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 19 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 20 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 23 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 24 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 25 Day 1
|
-16.67 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 26 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 28 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 30 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not evaluable with n=1
|
|
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
Cycle 32 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
The dyspnea item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=8 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 9 Day 1
|
4.44 score on a scale
Standard Deviation 6.086
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 10 Day 1
|
-2.22 score on a scale
Standard Deviation 12.172
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 26 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 2 Day 1
|
-5.56 score on a scale
Standard Deviation 16.798
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 3 Day 1
|
-7.41 score on a scale
Standard Deviation 11.476
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 4 Day 1
|
1.85 score on a scale
Standard Deviation 4.536
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 5 Day 1
|
7.41 score on a scale
Standard Deviation 9.072
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 6 Day 1
|
2.22 score on a scale
Standard Deviation 4.969
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 7 Day 1
|
-2.22 score on a scale
Standard Deviation 12.172
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 8 Day 1
|
-0.00 score on a scale
Standard Deviation 9.072
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 11 Day 1
|
-2.78 score on a scale
Standard Deviation 13.981
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 12 Day 1
|
5.56 score on a scale
Standard Deviation 7.857
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 13 Day 1
|
-5.56 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 14 Day 1
|
11.11 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 15 Day 1
|
0.00 score on a scale
Standard Deviation 0.000
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 16 Day 1
|
-11.11 score on a scale
Standard Deviation 15.713
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 17 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 18 Day 1
|
11.11 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 19 Day 1
|
-0.00 score on a scale
Standard Deviation 15.713
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 20 Day 1
|
11.11 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 21 Day 1
|
11.11 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 22 Day 1
|
-5.56 score on a scale
Standard Deviation 23.570
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 23 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 24 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 25 Day 1
|
5.56 score on a scale
Standard Deviation 7.857
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 28 Day 1
|
-0.00 score on a scale
Standard Deviation 15.713
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 30 Day 1
|
11.11 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
Cycle 32 Day 1
|
-0.00 score on a scale
Standard Deviation 15.713
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
The Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 was reported on a scale of 0 to 100, with higher scores indicating better global health status/functioning and a positive change from baseline indicating improvement.
Outcome measures
| Measure |
Telisotuzumab Vedotin
n=8 Participants
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 21 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 9 Day 1
|
-3.33 score on a scale
Standard Deviation 18.257
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 10 Day 1
|
3.33 score on a scale
Standard Deviation 7.454
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 11 Day 1
|
-4.17 score on a scale
Standard Deviation 8.333
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 12 Day 1
|
8.33 score on a scale
Standard Deviation 11.785
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 2 Day 1
|
3.13 score on a scale
Standard Deviation 14.042
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 3 Day 1
|
2.78 score on a scale
Standard Deviation 12.546
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 4 Day 1
|
-2.78 score on a scale
Standard Deviation 8.607
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 5 Day 1
|
-4.17 score on a scale
Standard Deviation 14.672
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 6 Day 1
|
1.67 score on a scale
Standard Deviation 12.360
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 7 Day 1
|
3.33 score on a scale
Standard Deviation 7.454
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 8 Day 1
|
4.17 score on a scale
Standard Deviation 8.333
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 13 Day 1
|
8.33 score on a scale
Standard Deviation 11.785
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 14 Day 1
|
16.67 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 15 Day 1
|
8.33 score on a scale
Standard Deviation 11.785
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 16 Day 1
|
4.17 score on a scale
Standard Deviation 5.893
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 17 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 18 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 19 Day 1
|
-8.33 score on a scale
Standard Deviation 11.785
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 20 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 22 Day 1
|
-4.17 score on a scale
Standard Deviation 5.893
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 23 Day 1
|
-16.67 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 24 Day 1
|
16.67 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 25 Day 1
|
8.33 score on a scale
Standard Deviation 11.785
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 26 Day 1
|
0.00 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 28 Day 1
|
-8.33 score on a scale
Standard Deviation 11.785
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 30 Day 1
|
16.67 score on a scale
Standard Deviation NA
SD not calculable with n=1
|
|
Change From Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Cycle 32 Day 1
|
-16.67 score on a scale
Standard Deviation 23.570
|
Adverse Events
Telisotuzumab Vedotin
Serious events: 3 serious events
Other events: 9 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Telisotuzumab Vedotin
n=9 participants at risk
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
DISEASE PROGRESSION
|
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
PNEUMONIA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
11.1%
1/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Telisotuzumab Vedotin
n=9 participants at risk
Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Eye disorders
KERATITIS
|
22.2%
2/9 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
3/9 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
ASTHENIA
|
33.3%
3/9 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
DISEASE PROGRESSION
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
FATIGUE
|
22.2%
2/9 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
MEDICAL DEVICE PAIN
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
General disorders
PYREXIA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
ORAL FUNGAL INFECTION
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
BLOOD TESTOSTERONE DECREASED
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
11.1%
1/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
WEIGHT DECREASED
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
11.1%
1/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
11.1%
1/9 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
PRESYNCOPE
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
TASTE DISORDER
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
22.2%
2/9 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER