Trial Outcomes & Findings for S0720: Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer (NCT NCT00792701)

NCT ID: NCT00792701

Last Updated: 2020-03-06

Results Overview

Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 85 participants
• Primary outcome timeframe: From time of registration to 84 days after surgical resection.
• Results posted on: 2020-03-06

Participant Flow

Participant milestones

Measure	Active Monitoring Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks. Active surveillance: Patients undergo active monitoring	Gemcitabine Hydrochloride and Cisplatin Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Overall Study STARTED	19	66
Overall Study Eligible	18	63
Overall Study Eligible and Analyzable	17	44
Overall Study COMPLETED	0	22
Overall Study NOT COMPLETED	19	44

Reasons for withdrawal

Measure	Active Monitoring Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks. Active surveillance: Patients undergo active monitoring	Gemcitabine Hydrochloride and Cisplatin Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Overall Study Adverse Event	0	22
Overall Study Ineligible	1	3
Overall Study Withdrawal by Subject	1	19
Overall Study Not protocol specified	17	0

Baseline Characteristics

S0720: Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Active Monitoring n=18 Participants Patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks. Active surveillance: Patients undergo active monitoring	Gemcitabine Hydrochloride and Cisplatin n=63 Participants Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Total n=81 Participants Total of all reporting groups
Age, Continuous	68.8 years n=5 Participants	63.3 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	37 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	26 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	58 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	52 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Histology Adenocarcinoma	8 Participants n=5 Participants	44 Participants n=7 Participants	52 Participants n=5 Participants
Histology Squamous	8 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants
Histology Large Cell	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Histology Bronchioloalveolar	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Histology Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Performance Status 0	13 Participants n=5 Participants	31 Participants n=7 Participants	44 Participants n=5 Participants
Performance Status 1	5 Participants n=5 Participants	32 Participants n=7 Participants	37 Participants n=5 Participants
Smoking History Current	7 Participants n=5 Participants	26 Participants n=7 Participants	33 Participants n=5 Participants
Smoking History Former	9 Participants n=5 Participants	30 Participants n=7 Participants	39 Participants n=5 Participants
Smoking History Never	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Stage IA	3 Participants n=5 Participants	22 Participants n=7 Participants	25 Participants n=5 Participants
Stage IB	15 Participants n=5 Participants	41 Participants n=7 Participants	56 Participants n=5 Participants
Weight Loss Last 6 Months <5%	15 Participants n=5 Participants	49 Participants n=7 Participants	64 Participants n=5 Participants
Weight Loss Last 6 Months 5-<10%	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Weight Loss Last 6 Months 10-20%	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Weight Loss Last 6 Months >20%	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Weight Loss Last 6 Months Unknown	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From time of registration to 84 days after surgical resection.

Population: Percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.

Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.

Outcome measures

Measure	All Eligible Patients n=81 Participants All patients who received a treatment assignment within the prespecified timeframe.	Gemcitabine Hydrochloride and Cisplatin Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting	71 Participants	—

SECONDARY outcome

Timeframe: From time of registration to maximum of 2 years

Outcome measures

Measure	All Eligible Patients n=17 Participants All patients who received a treatment assignment within the prespecified timeframe.	Gemcitabine Hydrochloride and Cisplatin n=44 Participants Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Two-year Disease-free Survival	71 percentage of participants Interval 43.0 to 87.0	83 percentage of participants Interval 68.0 to 91.0

SECONDARY outcome

Timeframe: From time of registration to maximum of 2 years

Population: Number of Subjects With Greater Than Grade 2 Toxicity Patients in the active monitoring arm were not followed for adverse events.

Patients in the active monitoring arm were not followed for adverse events.

Outcome measures

Measure	All Eligible Patients n=43 Participants All patients who received a treatment assignment within the prespecified timeframe.	Gemcitabine Hydrochloride and Cisplatin Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 ALT, SGPT (serum glutamic pyruvic transaminase)	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Anorexia	2 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Dehydration	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Fatigue (asthenia, lethargy, malaise)	2 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Febrile neutropenia	2 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Hearing: pts w/o audiogram not enroll monitor prgm	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Hemoglobin	2 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Mucositis/stomatitis (clinical exam) - Oral cavity	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Nausea	4 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Neutrophils/granulocytes (ANC/AGC)	17 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Platelets	8 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Pleural effusion (non-malignant)	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Potassium, serum-low (hypokalemia)	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Renal failure	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 SVT and nodal arrhythmia - Sinus bradycardia	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Sodium, serum-low (hyponatremia)	2 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Syncope (fainting)	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Thrombosis/embolism (vascular access-related)	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Thrombosis/thrombus/embolism	1 participants	—
Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0 Vomiting	4 participants	—

SECONDARY outcome

Timeframe: From time of registration to maximum of 2 years

Population: Protein expression relationships were analyzed in the overall patient population, and not by arm.

RRM1 and ERCC1 protein levels are expressed as a simple score with no units.

Outcome measures

Measure	All Eligible Patients n=85 Participants All patients who received a treatment assignment within the prespecified timeframe.	Gemcitabine Hydrochloride and Cisplatin Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens. RRM1 Protein Score	39.7 Scores Interval 2.4 to 234.3	—
Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens. ERCC1 Protein Score	41.9 Scores Interval 4.3 to 211.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From time of registration to maximum of 2 years

Population: Due to lack of funding, the assay was never performed. Thus, this outcome could not be analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From time of registration to maximum of 2 years

Population: Due to lack of funding, the protein expression data were never collected. Thus, this outcome could not be analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From time of registration to maximum of 2 years

Outcome measures

Measure	All Eligible Patients n=81 Participants All patients who received a treatment assignment within the prespecified timeframe.	Gemcitabine Hydrochloride and Cisplatin Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Relationship Between RNA and Protein Expression of RRM1 and ERCC1 RRM1 Protein Score	39.7 Scores Interval 2.4 to 234.3	—
Relationship Between RNA and Protein Expression of RRM1 and ERCC1 ERCC1 Protein Score	41.9 Scores Interval 4.3 to 211.2	—

Adverse Events

Gemcitabine Hydrochloride and Cisplatin

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gemcitabine Hydrochloride and Cisplatin n=43 participants at risk Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Injury, poisoning and procedural complications Thrombosis/embolism (vascular access-related)	2.3% 1/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	2.3% 1/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.

Other adverse events

Measure	Gemcitabine Hydrochloride and Cisplatin n=43 participants at risk Beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin	58.1% 25/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Ear and labyrinth disorders Tinnitus	27.9% 12/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Gastrointestinal disorders Constipation	37.2% 16/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Gastrointestinal disorders Diarrhea	23.3% 10/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Gastrointestinal disorders Heartburn/dyspepsia	14.0% 6/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Gastrointestinal disorders Nausea	79.1% 34/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Gastrointestinal disorders Vomiting	41.9% 18/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
General disorders Edema: limb	14.0% 6/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
General disorders Fatigue (asthenia, lethargy, malaise)	72.1% 31/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
General disorders Pain-Other	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	14.0% 6/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Investigations AST, SGOT	23.3% 10/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Investigations Alkaline phosphatase	20.9% 9/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Investigations Creatinine	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Investigations Leukocytes (total WBC)	27.9% 12/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Investigations Metabolic/Laboratory-Other	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Investigations Neutrophils/granulocytes (ANC/AGC)	65.1% 28/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Investigations Platelets	32.6% 14/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Anorexia	41.9% 18/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Dehydration	14.0% 6/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	34.9% 15/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	14.0% 6/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	18.6% 8/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - body/general	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Back	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Joint	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Musculoskeletal and connective tissue disorders Pain - Muscle	14.0% 6/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Nervous system disorders Dizziness	30.2% 13/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Nervous system disorders Neuropathy: sensory	16.3% 7/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Nervous system disorders Pain - Head/headache	27.9% 12/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Nervous system disorders Taste alteration (dysgeusia)	23.3% 10/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Psychiatric disorders Insomnia	23.3% 10/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Psychiatric disorders Mood alteration - anxiety	11.6% 5/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Respiratory, thoracic and mediastinal disorders Cough	18.6% 8/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	16.3% 7/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Skin and subcutaneous tissue disorders Dry skin	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	16.3% 7/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Skin and subcutaneous tissue disorders Pruritus/itching	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Skin and subcutaneous tissue disorders Rash/desquamation	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Vascular disorders Hypertension	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Vascular disorders Hypotension	9.3% 4/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.
Vascular disorders Thrombosis/thrombus/embolism	7.0% 3/43 • From time of registration to maximum of 2 years. Patients in the active monitoring arm were not followed for adverse events. All SAEs and AEs Patients in the active monitoring arm were not followed for adverse events.

Additional Information

Lung Committee Statistician

SWOG Statistical Center

Phone: 206-667-6197

Email: jmoon@fredhutch.org

Results disclosure agreements

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