Trial Outcomes & Findings for Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer (NCT NCT01880528)

Last Updated: 2020-01-02

Results Overview

Incidence of grade 3 or higher hypotension, acute kidney injury, allergic reaction, or anaphylaxis, as measured using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Descriptive statistics of frequency (percentage) will be used to summarize adverse event (AE) incidence and severity in the lisinopril and placebo arms separately.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 3 months post-radiation therapy

Results posted on

2020-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Lisinopril) Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Overall Study STARTED	12	11
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Lisinopril) Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Overall Study Other	1	1

Baseline Characteristics

Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Lisinopril) n=11 Participants Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) n=10 Participants Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.	Total n=21 Participants Total of all reporting groups
Age, Continuous	62.0 years n=93 Participants	62.0 years n=4 Participants	62.0 years n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 3 months post-radiation therapy

Outcome measures

Outcome measures
Measure	Arm I (Lisinopril) n=11 Participants Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) n=10 Participants Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Incidence of Grade 3 or Higher Hypotension, Acute Kidney Injury, Allergic Reaction, or Anaphylaxis, as Measured Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 3 months post-radiation therapy

Population: Patients who completed the LCSS Item #4 at any time during the study are included in this analysis.

Acute respiratory distress (dyspnea), measured using of the maximum score, at any time, of the shortness of breath question (Item #4 "How much shortness of breath do you have?") on the Lung Cancer Symptom Scale (LCSS) (Worst Dyspnea Score). The LCSS tool contains 6 major symptoms associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global quality of life (QOL). The item scale ranges from 0-10 (0 = None; 10 = As much as it could be) where the LCSS scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability. Patient scores range from 0 to 100, where 100 was best QOL (i.e. less pulmonary distress).

Outcome measures

Outcome measures
Measure	Arm I (Lisinopril) n=12 Participants Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) n=10 Participants Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Acute Respiratory Distress (Dyspnea), Measured Using of the Maximum Score, at Any Time, of the Shortness of Breath Question (Item #4) on the LCSS (Worst Dyspnea Score)	77.5 score on a scale Standard Deviation 23.8	42.0 score on a scale Standard Deviation 27.8

SECONDARY outcome

Timeframe: At Week 4

Population: Patients who completed Item #3 on the SEQ at week 4 are included in this analysis.

Experience shortness of breath during exercise as measured using Item #3 ("Over the past week, did you experience shortness of breath when you exercise or exert yourself?") on the Symptom Experience Questionnaire (SEQ) at Baseline. The item scale ranges from 0-10 (0 = Not at all; 10 = As bad as it can be) where the SEQ scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.

Outcome measures

Outcome measures
Measure	Arm I (Lisinopril) n=3 Participants Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) n=7 Participants Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Experience Shortness of Breath During Exercise as Measured Using Item #3 on the Symptom Experience Questionnaire (SEQ) at Week 4	100 score on a scale Standard Deviation 0	68.6 score on a scale Standard Deviation 27.9

SECONDARY outcome

Timeframe: At Week 4

Population: Patients who completed item #5 on the EORTC-QLQ-LC13 at week 4 are included in this analysis.

Dyspnea when climbing as measured using item #5 ("Were you short of breath when you climbed stairs?") of the EORTC-QLQ-LC13 at Week 4. The item scale ranges from 1-4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.

Outcome measures

Outcome measures
Measure	Arm I (Lisinopril) n=8 Participants Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) n=9 Participants Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Quality of Life (Dyspnea When Climbing Stairs) Assessed Using Item #5 of the European Organization for Research on the Treatment of Cancer Lung Cancer Module Survey (EORTC-QLQ-LC13) at Week 4	83.3 score on a scale Standard Deviation 17.8	51.9 score on a scale Standard Deviation 33.8

SECONDARY outcome

Timeframe: At Week 4

Population: Patients who completed the LCSS at week 4 are included in this analysis.

Total LCSS score as measured using the Lung Cancer Symptom Scale (LCSS) at Week 4. The item scale ranges from 0-10 (0 = None; 10 = As much as it could be) where the LCSS scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.

Outcome measures

Outcome measures
Measure	Arm I (Lisinopril) n=8 Participants Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) n=9 Participants Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Total LCSS Score as Measure by the Lung Cancer Symptom Scale (LCSS) at Week 4	83.8 score on a scale Standard Deviation 11.2	66.5 score on a scale Standard Deviation 17.0

Adverse Events

Arm I (Lisinopril)

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm II (Placebo)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Lisinopril) n=12 participants at risk Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) n=10 participants at risk Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Blood and lymphatic system disorders Anemia	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Blood and lymphatic system disorders Febrile neutropenia	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Neutrophil count decreased	16.7% 2/12 • Number of events 5 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Platelet count decreased	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations White blood cell decreased	16.7% 2/12 • Number of events 4 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Syncope	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/12 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	10.0% 1/10 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Vascular disorders Hematoma	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 3 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.

Other adverse events

Other adverse events
Measure	Arm I (Lisinopril) n=12 participants at risk Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.	Arm II (Placebo) n=10 participants at risk Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD.
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Esophagitis	25.0% 3/12 • Number of events 4 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Fatigue	8.3% 1/12 • Number of events 5 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations Platelet count decreased	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Investigations White blood cell decreased	8.3% 1/12 • Number of events 2 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	10.0% 1/10 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Presyncope	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Renal and urinary disorders Acute kidney injury	25.0% 3/12 • Number of events 5 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Cough	75.0% 9/12 • Number of events 26 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	90.0% 9/10 • Number of events 32 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.3% 1/12 • Number of events 1 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/10 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Vascular disorders Hypotension	41.7% 5/12 • Number of events 6 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	40.0% 4/10 • Number of events 5 • Up to 3 months post-radiation therapy Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.

Additional Information

Terence T Sio, MD, MS

Mayo Clinic

Phone: 480/301-7050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place