Trial Outcomes & Findings for Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (NCT NCT03132532)

NCT ID: NCT03132532

Last Updated: 2025-11-25

Results Overview

A Cox proportional hazards model stratified by stratification factors will be used to model PFS as a function of dose to test for an overall dose effect (a one-sided p-value \< 0.10 will be considered as significant evidence of a dose effect). Subsequently, separate Cox models stratified by stratification factors will compare PFS between 72 Gy and 60 Gy (for each, a one-sided p-value \< 0.10 will be considered as significant evidence of superiority). Kaplan Meier estimates and curves by dose level will also be generated

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From randomization to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years

Results posted on

2025-11-25

Participant Flow

Participant milestones

Participant milestones
Measure
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.\> \> Carboplatin: Chemotherapy\> \> Cisplatin: Chemotherapy\> \> Etoposide: Chemotherapy\> \> Paclitaxel: Chemotherapy\> \> Pemetrexed: Chemotherapy\> \> Proton Beam Radiation Therapy: Undergo PBT\> \> Quality-of-Life Assessment: Ancillary studies\> \> Questionnaire Administration: Ancillary studies
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.\> \> Carboplatin: Chemotherapy\> \> Paclitaxel: Chemotherapy\> \> Proton Beam Radiation Therapy: Undergo PBT\> \> Quality-of-Life Assessment: Ancillary studies\> \> Questionnaire Administration: Ancillary studies
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
7
Overall Study
NOT COMPLETED
0
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One patient on Arm C is missing ECOG data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.\> \> Carboplatin: Chemotherapy\> \> Cisplatin: Chemotherapy\> \> Etoposide: Chemotherapy\> \> Paclitaxel: Chemotherapy\> \> Pemetrexed: Chemotherapy\> \> Proton Beam Radiation Therapy: Undergo PBT\> \> Quality-of-Life Assessment: Ancillary studies\> \> Questionnaire Administration: Ancillary studies
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.\> \> Carboplatin: Chemotherapy\> \> Paclitaxel: Chemotherapy\> \> Proton Beam Radiation Therapy: Undergo PBT\> \> Quality-of-Life Assessment: Ancillary studies\> \> Questionnaire Administration: Ancillary studies
Total
n=17 Participants
Total of all reporting groups
Age, Continuous
75.50 years
n=10 Participants
74.0 years
n=7 Participants
74.0 years
n=17 Participants
Sex: Female, Male
Female
6 Participants
n=10 Participants
3 Participants
n=7 Participants
9 Participants
n=17 Participants
Sex: Female, Male
Male
4 Participants
n=10 Participants
4 Participants
n=7 Participants
8 Participants
n=17 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
n=10 Participants
7 Participants
n=7 Participants
16 Participants
n=17 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=10 Participants
0 Participants
n=7 Participants
1 Participants
n=17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Race (NIH/OMB)
Asian
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Race (NIH/OMB)
White
10 Participants
n=10 Participants
7 Participants
n=7 Participants
17 Participants
n=17 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Method of Payment
MEDICARE
9 Participants
n=10 Participants
5 Participants
n=7 Participants
14 Participants
n=17 Participants
Method of Payment
MEDICARE AND PRIVATE INSURANCE
1 Participants
n=10 Participants
0 Participants
n=7 Participants
1 Participants
n=17 Participants
Method of Payment
PRIVATE INSURANCE
0 Participants
n=10 Participants
2 Participants
n=7 Participants
2 Participants
n=17 Participants
Height (Cm)
167.100 cm
STANDARD_DEVIATION 11.799 • n=10 Participants
171.714 cm
STANDARD_DEVIATION 10.965 • n=7 Participants
169.000 cm
STANDARD_DEVIATION 11.352 • n=17 Participants
Weight (Kg)
73.460 Kg
STANDARD_DEVIATION 13.422 • n=10 Participants
84.900 Kg
STANDARD_DEVIATION 18.190 • n=7 Participants
78.171 Kg
STANDARD_DEVIATION 16.096 • n=17 Participants
Smoking Cessation
Quit
8 Participants
n=10 Participants
5 Participants
n=7 Participants
13 Participants
n=17 Participants
Smoking Cessation
Kept smoking
2 Participants
n=10 Participants
1 Participants
n=7 Participants
3 Participants
n=17 Participants
Smoking Cessation
Non-smoker
0 Participants
n=10 Participants
1 Participants
n=7 Participants
1 Participants
n=17 Participants
Baseline QOL
60
0 Participants
n=10 Participants
1 Participants
n=7 Participants
1 Participants
n=17 Participants
Baseline QOL
70
0 Participants
n=10 Participants
2 Participants
n=7 Participants
2 Participants
n=17 Participants
Baseline QOL
80
2 Participants
n=10 Participants
0 Participants
n=7 Participants
2 Participants
n=17 Participants
Baseline QOL
90
5 Participants
n=10 Participants
3 Participants
n=7 Participants
8 Participants
n=17 Participants
Baseline QOL
100
3 Participants
n=10 Participants
1 Participants
n=7 Participants
4 Participants
n=17 Participants
ECOG Performance Status
0
3 Participants
n=10 Participants • One patient on Arm C is missing ECOG data
3 Participants
n=6 Participants • One patient on Arm C is missing ECOG data
6 Participants
n=16 Participants • One patient on Arm C is missing ECOG data
ECOG Performance Status
1
7 Participants
n=10 Participants • One patient on Arm C is missing ECOG data
3 Participants
n=6 Participants • One patient on Arm C is missing ECOG data
10 Participants
n=16 Participants • One patient on Arm C is missing ECOG data
Mayo prognostic score
32-37
0 Participants
n=10 Participants
1 Participants
n=7 Participants
1 Participants
n=17 Participants
Mayo prognostic score
38-43
4 Participants
n=10 Participants
3 Participants
n=7 Participants
7 Participants
n=17 Participants
Mayo prognostic score
44-47
4 Participants
n=10 Participants
2 Participants
n=7 Participants
6 Participants
n=17 Participants
Mayo prognostic score
48-52
2 Participants
n=10 Participants
1 Participants
n=7 Participants
3 Participants
n=17 Participants

PRIMARY outcome

Timeframe: From randomization to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years

A Cox proportional hazards model stratified by stratification factors will be used to model PFS as a function of dose to test for an overall dose effect (a one-sided p-value \< 0.10 will be considered as significant evidence of a dose effect). Subsequently, separate Cox models stratified by stratification factors will compare PFS between 72 Gy and 60 Gy (for each, a one-sided p-value \< 0.10 will be considered as significant evidence of superiority). Kaplan Meier estimates and curves by dose level will also be generated

Outcome measures

Outcome measures
Measure
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Cisplatin: Chemotherapy \> \> Etoposide: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Pemetrexed: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Proportion of Participants With Progression Free Survival (PFS)
0.429 proportion of participants
Interval 0.182 to 1.0
0.6 proportion of participants
Interval 0.362 to 0.995

SECONDARY outcome

Timeframe: From randomization to death due to any cause, assessed up to 5 years

Will be modeled using Cox models. Kaplan-Meier estimates and curves by dose level will also be generated. OS will again be analyzed as exploratory analysis after 50 deaths per primary pairwise comparison have occurred or after all patients have completed follow-up (whichever occurs first).

Outcome measures

Outcome measures
Measure
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Cisplatin: Chemotherapy \> \> Etoposide: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Pemetrexed: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Overall Survival (OS)
Alive
2 Participants
4 Participants
Overall Survival (OS)
Dead
5 Participants
6 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events are graded on a scale of 0-5 with 5 being worst. The number of participants with Grade 2 or higher adverse events will be reported.

Outcome measures

Outcome measures
Measure
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Cisplatin: Chemotherapy \> \> Etoposide: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Pemetrexed: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Number of Participants With Adverse Events
AE Grade 2+
6 Participants
9 Participants
Number of Participants With Adverse Events
AE Grade 3+
5 Participants
6 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Defined as the proportion of participants with documentation of local recurrence. The cumulative incidence of local failure will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk).

Outcome measures

Outcome measures
Measure
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=8 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Cisplatin: Chemotherapy \> \> Etoposide: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Pemetrexed: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Proportion of Participants With Local-regional Failure
0.14 proportion of participants
Interval 0.026 to 0.51
0.2 proportion of participants
Interval 0.057 to 0.51

SECONDARY outcome

Timeframe: Up to 5 years

Defined as the proportion of participants with documentation of distant metastasis. The cumulative incidence of distant metastasis will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk).

Outcome measures

Outcome measures
Measure
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=7 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 Participants
Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity. \> \> Carboplatin: Chemotherapy \> \> Cisplatin: Chemotherapy \> \> Etoposide: Chemotherapy \> \> Paclitaxel: Chemotherapy \> \> Pemetrexed: Chemotherapy \> \> Proton Beam Radiation Therapy: Undergo PBT \> \> Quality-of-Life Assessment: Ancillary studies \> \> Questionnaire Administration: Ancillary studies
Proportion of Participants With Distant Metastasis
0.29 proportion of participants
Interval 0.08 to 0.64
0.1 proportion of participants
Interval 0.018 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Measured using the single item Linear Analogue Self-Assessment scale. Descriptive statistics by dose level at each time point will include means, standard deviations, medians, and ranges for each scale. Descriptive graphical techniques will include mean plots by dose over time for each scale. Mixed models will be used to compare each scale across dose levels at each post-baseline time point while adjusting for the baseline value of scale. Will graphically explore patterns of missing data and will employ pattern mixture models for longitudinal analyses. The lowest number measuring worst and higher number measuring best outcome.

Outcome measures

Outcome data not reported

Adverse Events

Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)

Serious events: 5 serious events
Other events: 10 other events
Deaths: 6 deaths

Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)

Serious events: 5 serious events
Other events: 7 other events
Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 participants at risk
Questionnaire Administration: Ancillary studies
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=9 participants at risk
Questionnaire Administration: Ancillary studies
General disorders
Death NOS
50.0%
5/10 • Number of events 5 • Up to 5 years
55.6%
5/9 • Number of events 5 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
0.00%
0/10 • Up to 5 years
11.1%
1/9 • Number of events 1 • Up to 5 years

Other adverse events

Other adverse events
Measure
Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT)
n=10 participants at risk
Questionnaire Administration: Ancillary studies
Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT)
n=9 participants at risk
Questionnaire Administration: Ancillary studies
Gastrointestinal disorders
Esophageal pain
10.0%
1/10 • Number of events 1 • Up to 5 years
0.00%
0/9 • Up to 5 years
Gastrointestinal disorders
Esophagitis
70.0%
7/10 • Number of events 15 • Up to 5 years
77.8%
7/9 • Number of events 11 • Up to 5 years
Gastrointestinal disorders
Nausea
40.0%
4/10 • Number of events 5 • Up to 5 years
44.4%
4/9 • Number of events 4 • Up to 5 years
Gastrointestinal disorders
Vomiting
10.0%
1/10 • Number of events 1 • Up to 5 years
0.00%
0/9 • Up to 5 years
General disorders
Fatigue
80.0%
8/10 • Number of events 16 • Up to 5 years
66.7%
6/9 • Number of events 9 • Up to 5 years
General disorders
Pain
20.0%
2/10 • Number of events 2 • Up to 5 years
22.2%
2/9 • Number of events 3 • Up to 5 years
Injury, poisoning and procedural complications
Dermatitis radiation
60.0%
6/10 • Number of events 6 • Up to 5 years
77.8%
7/9 • Number of events 7 • Up to 5 years
Investigations
Weight loss
30.0%
3/10 • Number of events 3 • Up to 5 years
22.2%
2/9 • Number of events 2 • Up to 5 years
Metabolism and nutrition disorders
Anorexia
10.0%
1/10 • Number of events 1 • Up to 5 years
33.3%
3/9 • Number of events 3 • Up to 5 years
Metabolism and nutrition disorders
Dehydration
50.0%
5/10 • Number of events 7 • Up to 5 years
55.6%
5/9 • Number of events 5 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Cough
70.0%
7/10 • Number of events 16 • Up to 5 years
77.8%
7/9 • Number of events 10 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Dyspnea
80.0%
8/10 • Number of events 18 • Up to 5 years
55.6%
5/9 • Number of events 7 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Pneumonitis
40.0%
4/10 • Number of events 5 • Up to 5 years
22.2%
2/9 • Number of events 2 • Up to 5 years
Respiratory, thoracic and mediastinal disorders
Productive cough
10.0%
1/10 • Number of events 2 • Up to 5 years
0.00%
0/9 • Up to 5 years
Cardiac disorders
Myocardial infarction
0.00%
0/10 • Up to 5 years
11.1%
1/9 • Number of events 1 • Up to 5 years
Gastrointestinal disorders
Constipation
60.0%
6/10 • Number of events 8 • Up to 5 years
22.2%
2/9 • Number of events 3 • Up to 5 years
Gastrointestinal disorders
Diarrhea
10.0%
1/10 • Number of events 1 • Up to 5 years
11.1%
1/9 • Number of events 1 • Up to 5 years
Gastrointestinal disorders
Dysphagia
90.0%
9/10 • Number of events 18 • Up to 5 years
44.4%
4/9 • Number of events 4 • Up to 5 years

Additional Information

Dr. Steven E. Schild

Mayo Clinic

Phone: 480-342-4800

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place