Trial Outcomes & Findings for A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients (NCT NCT02879617)

NCT ID: NCT02879617

Last Updated: 2024-01-05

Results Overview

Median length of time from the start of treatment from start of treatment to death from any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: Up to 30 months
• Results posted on: 2024-01-05

Participant Flow

Registered for study.

Participant milestones

Measure	Durvalumab Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Study STARTED	47
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients

Baseline characteristics by cohort

Measure	Durvalumab n=47 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Age, Continuous	76.4 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	46 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
Smoking Status Former	36 Participants n=5 Participants
Smoking Status Current	10 Participants n=5 Participants
Smoking Status Never	1 Participants n=5 Participants
Histology ADENOCARCINOMA, METASTATIC, NOS	7 Participants n=5 Participants
Histology ADENOCARCINOMA, N/A	2 Participants n=5 Participants
Histology ADENOCARCINOMA, NOS	16 Participants n=5 Participants
Histology BASALOID SQUAMOUS CELL CARCINOMA	1 Participants n=5 Participants
Histology METASTATIC ADENOSQUAMOUS CARCINOMA	2 Participants n=5 Participants
Histology NEOPLASM, MALIGNANT	2 Participants n=5 Participants
Histology NON-SMALL CELL CA	5 Participants n=5 Participants
Histology PLEOMORPHIC CARCINOMA	1 Participants n=5 Participants
Histology SQUAMOUS CELL CA METASTATIC, NOS	3 Participants n=5 Participants
Histology SQUAMOUS CELL CA, LG CELL, NONKER, MET	1 Participants n=5 Participants
Histology SQUAMOUS CELL CARCINOMA, NOS	7 Participants n=5 Participants
ECOG Performance Status = 2	47 Participants n=5 Participants
Disease Stage STAGE IIIB	6 Participants n=5 Participants
Disease Stage STAGE IV	38 Participants n=5 Participants
Disease Stage STAGE IVB	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 months

Population: Patients evaluable for safety and efficacy that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.

Median length of time from the start of treatment from start of treatment to death from any cause.

Outcome measures

Measure	Durvalumab n=47 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Survival (OS)	6.00 months Interval 4.0 to 10.0

PRIMARY outcome

Timeframe: At 12 months

Population: Patients evaluable for safety and efficacy that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.

Number of patients alive at 12 months post start of treatment.

Outcome measures

Measure	Durvalumab n=47 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Survival (OS12)	15 participants

PRIMARY outcome

Timeframe: At 24 months

Population: Patients evaluable for safety and efficacy that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.

Number of patients alive at 24 months post start of treatment.

Outcome measures

Measure	Durvalumab n=47 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Survival (OS24)	8 participants

PRIMARY outcome

Timeframe: Up to 30 months

Population: Patients that received study at least one cycle of treatment.

Number of participants with ≥ Grade 3 adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 that are at least possibly related to study treatment.

Outcome measures

Measure	Durvalumab n=9 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Treatment-related Adverse Events ≥ Grade 3 EYE DISORDERS - Optic Nerve Leak	1 Participants
Treatment-related Adverse Events ≥ Grade 3 GASTROINTESTINAL DISORDERS - Colitis	1 Participants
Treatment-related Adverse Events ≥ Grade 3 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Fatigue	1 Participants
Treatment-related Adverse Events ≥ Grade 3 RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Pneumonitis	2 Participants
Treatment-related Adverse Events ≥ Grade 3 INVESTIGATIONS - Lymphocyte count decreased	1 Participants
Treatment-related Adverse Events ≥ Grade 3 CARDIAC DISORDERS - Cardiac arrest	1 Participants
Treatment-related Adverse Events ≥ Grade 3 INVESTIGATIONS - Lipase increased	1 Participants
Treatment-related Adverse Events ≥ Grade 3 METABOLISM AND NUTRITION DISORDERS - Hyponatremia	1 Participants

SECONDARY outcome

Timeframe: Up to 30 months

Population: Radiologically evaluable patients that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.

Median duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=46 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Progression-Free Survival (PFS)	3.00 months Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: At 12 months

Population: Radiologically evaluable patients that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.

Number of patients without progressive disease or death at 12 months from start of treatment. Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=46 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Progression-Free Survival (PFS) at 12 Months	7 participants

SECONDARY outcome

Timeframe: At 24 months

Population: Radiologically evaluable patients that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle.

Number of patients without progressive disease or death at 24 months from start of treatment Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=46 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Progression-Free Survival (PFS) at 24 Months	4 participants

SECONDARY outcome

Timeframe: At 12 months

Population: Radiologically evaluable patients that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle, and for whom PD-L1 status is known.

Number of patients of know PD-L1 status without progressive disease or death at 12 months from start of treatment. Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=7 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Progression-Free Survival (PFS) by PD-L1 Expression at 12 Months PD-L1=0	1 participants
Progression-Free Survival (PFS) by PD-L1 Expression at 12 Months 0%<PD-L1<50%	4 participants
Progression-Free Survival (PFS) by PD-L1 Expression at 12 Months PD-L1≥50%	2 participants

SECONDARY outcome

Timeframe: At 24 months

Population: Radiologically evaluable patients that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle, and for whom PD-L1 status is known.

Number of patients of know PD-L1 status without progressive disease or death at 24 months from start of treatment Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=4 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Progression-Free Survival (PFS) by PD-L1 Expression Status at 24 Months 0%<PD-L1<50%	3 participants
Progression-Free Survival (PFS) by PD-L1 Expression Status at 24 Months PD-L1≥50%	1 participants
Progression-Free Survival (PFS) by PD-L1 Expression Status at 24 Months PD-L1=0	0 participants

SECONDARY outcome

Timeframe: At 12 months

Population: Patients evaluable for safety and efficacy that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle, and for whom PD-L1 is known.

Number of patients with know PD-L1 status that are alive at 12 months post start of treatment.

Outcome measures

Measure	Durvalumab n=13 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Survival by PD-L1 Expression Status at 12 Months 0%<PD-L1<50%	5 participants
Overall Survival by PD-L1 Expression Status at 12 Months PD-L1≥50%	3 participants
Overall Survival by PD-L1 Expression Status at 12 Months PD-L1=0	5 participants

SECONDARY outcome

Timeframe: At 24 months

Population: Patients evaluable for safety and efficacy that received at least one dose of the treatment who did not withdraw for reasons other than disease progression or toxicity before second treatment cycle, and for whom PD-L1 is known.

Number of patients with know PD-L1 status that are alive at 24 months post start of treatment.

Outcome measures

Measure	Durvalumab n=8 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Survival by PD-L1 Expression Status at 24 Months PD-L1=0	3 participants
Overall Survival by PD-L1 Expression Status at 24 Months 0%<PD-L1<50%	3 participants
Overall Survival by PD-L1 Expression Status at 24 Months PD-L1≥50%	2 participants

SECONDARY outcome

Timeframe: Up to 30 months

Population: Treated patients that are evaluable for radiologic response.

Percentage of patients with a Best Response of Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.0, for target lesions: PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither PR nor PD (target lesions); persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits. PD: at least a 20% increase in sum of diameters (target lesions), taking as reference the smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of at least 5 mm. (includes appearance of one or more new lesions) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=38 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Response Rate (ORR) Partial Response (PD)	26 percentage of participants
Overall Response Rate (ORR) Stable Disease (SD)	47 percentage of participants
Overall Response Rate (ORR) Progressive Disease (PD)	26 percentage of participants

SECONDARY outcome

Timeframe: Up to 30 months

Population: Treated patients that are radiologically evaluable and for whom PD-LI status is known.

Percentage of patients with PD-L1 expression status = 0, with a Best Response of Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.0 (target lesions): PR: ≥30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither PR nor PD (target lesions); persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits. PD: ≥20% increase in sum of diameters (target lesions), taking as reference the smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of at least 5 mm. (includes appearance of one or more new lesions) ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=13 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status = 0 Partial Response	31 percentage of participants
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status = 0 Progressive Disease	31 percentage of participants
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status = 0 Stable Disease	38 percentage of participants

SECONDARY outcome

Timeframe: Up to 30 months

Population: Treated patients that are radiologically evaluable and for whom PD-LI status is known.

Percentage of patients with PD-L1 expression status=0%<PD-L1<50%, with a Best Response of Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.0 (target lesions): PR: ≥30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither PR nor PD (target lesions); persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits. PD: ≥20% increase in sum of diameters (target lesions), taking as reference the smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of at least 5 mm. (includes appearance of one or more new lesions) ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=10 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status = 0%<PD-L1<50%. Partial Response	30 percentage of participants
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status = 0%<PD-L1<50%. Stable Disease	60 percentage of participants
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status = 0%<PD-L1<50%. Progressive Disease	10 percentage of participants

SECONDARY outcome

Timeframe: Up to 30 months

Population: Treated patients that are radiologically evaluable and for whom PD-LI status is known.

Percentage of patients with PD-L1 expression status ≥50%, with a Best Response of Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.0 (target lesions): PR: ≥30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither PR nor PD (target lesions); persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits. PD: ≥20% increase in sum of diameters (target lesions), taking as reference the smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of at least 5 mm. (includes appearance of one or more new lesions) ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Measure	Durvalumab n=4 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status ≥50% Progressive Disease	50 percentage of participants
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status ≥50% Partial Response	25 percentage of participants
Overall Response Rate (ORR) in Patients With PD-L1 Expression Status ≥50% Stable Disease	25 percentage of participants

SECONDARY outcome

Timeframe: At baseline

Population: Treated patients that completed Health Related Quality of Life (HRQL) - FACT-G questionnaire.

Patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Outcome measures

Measure	Durvalumab n=36 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Health Related Quality of Life (HRQL) - FACT-G	78.2908 score on a scale Standard Deviation 16.1690

SECONDARY outcome

Timeframe: Within first two treatment cycles, up to 56 days

Population: Treated patients that completed Health Related Quality of Life (HRQL) - FACT-G questionnaire.

Patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Outcome measures

Measure	Durvalumab n=40 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Health Related Quality of Life (HRQL) - FACT-G	76.6788 score on a scale Standard Deviation 16.8937

SECONDARY outcome

Timeframe: At 6 months

Population: Treated patients that completed Health Related Quality of Life (HRQL) - FACT-G questionnaire.

Patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Outcome measures

Measure	Durvalumab n=13 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Health Related Quality of Life (HRQL) - FACT-G	80.5103 score on a scale Standard Deviation 17.8968

SECONDARY outcome

Timeframe: At 12 months

Population: Treated patients that completed Health Related Quality of Life (HRQL) - FACT-G questionnaire.

Patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Outcome measures

Measure	Durvalumab n=10 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
Health Related Quality of Life (HRQL) - FACT-G	80.0166 score on a scale Standard Deviation 13.3727

SECONDARY outcome

Timeframe: At baseline

Population: Treated patients that completed FACT-L Lung cancer subscale (LCS) questionnaire.

The FACT-LCS is the lung cancer subscale of the FACT-L. LCS includes the average symptom burden index (ASBI; based on 5 symptoms: anorexia, fatigue, cough, dyspnea, hemoptysis, and pain) and the 3-item global index (2-IGI; symptom distress, interference with activities, and health-related quality of life). Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-28. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Outcome measures

Measure	Durvalumab n=34 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
FACT Lung Cancer Subscale (LCS)	18.5 score on a scale Standard Deviation 5.52268

SECONDARY outcome

Timeframe: Within first two treatment cycles, up to 56 days

Population: Treated patients that completed FACT-L Lung cancer subscale (LCS) questionnaire.

The FACT-LCS is the lung cancer subscale of the FACT-L. LCS includes the average symptom burden index (ASBI; based on 5 symptoms: anorexia, fatigue, cough, dyspnea, hemoptysis, and pain) and the 3-item global index (2-IGI; symptom distress, interference with activities, and health-related quality of life). Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-28. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Outcome measures

Measure	Durvalumab n=39 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
FACT Lung Cancer Subscale (LCS)	17.4090 score on a scale Standard Deviation 5.69679

SECONDARY outcome

Timeframe: At 6 months

Population: Treated patients that completed FACT-L Lung cancer subscale (LCS) questionnaire.

The FACT-LCS is the lung cancer subscale of the FACT-L. LCS includes the average symptom burden index (ASBI; based on 5 symptoms: anorexia, fatigue, cough, dyspnea, hemoptysis, and pain) and the 3-item global index (2-IGI; symptom distress, interference with activities, and health-related quality of life). Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-28. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Outcome measures

Measure	Durvalumab n=13 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
FACT Lung Cancer Subscale (LCS)	19.6346 score on a scale Standard Deviation 3.32909

SECONDARY outcome

Timeframe: At 12 months

Population: Treated patients that completed FACT-L Lung cancer subscale (LCS) questionnaire

The FACT-LCS is the lung cancer subscale of the FACT-L. LCS includes the average symptom burden index (ASBI; based on 5 symptoms: anorexia, fatigue, cough, dyspnea, hemoptysis, and pain) and the 3-item global index (2-IGI; symptom distress, interference with activities, and health-related quality of life). Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-28. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Outcome measures

Measure	Durvalumab n=9 Participants Durvalumab: 1500 mg administered intravenously (IV) on day 1 of every 28 day cycle
FACT Lung Cancer Subscale (LCS)	17.9444 score on a scale Standard Deviation 2.92024

Adverse Events

Durvalumab

Serious events: 26 serious events

Other events: 45 other events

Deaths: 40 deaths

Serious adverse events

Measure	Durvalumab n=47 participants at risk Durvalumab: 1500 mg administered intravenously (IV) on Day 1 of every 28 day cycle
Blood and lymphatic system disorders Anemia	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Atrial fibrillation	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac arrest	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Pericardial effusion	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Colitis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Death NOS	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Fatigue	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Non-cardiac chest pain	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Pain	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Lung infection	21.3% 10/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Sepsis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Urinary tract infection	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Injury, poisoning and procedural complications Fall	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Injury, poisoning and procedural complications Fracture	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Injury, poisoning and procedural complications Spinal fracture	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Acidosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Dehydration	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypercalcemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypokalemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypomagnesemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyR hip, R groin, RLQ pain	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Myalgia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Pain in extremity	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Depressed level of consciousness	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Nervous system disorders - Other, specifyAphasia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Stroke	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Proteinuria	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Aspiration	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Cough	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Dyspnea	23.4% 11/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Hypoxia	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.6% 5/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Productive cough	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Pulmonary edema	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory failure	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Hypotension	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03

Other adverse events

Measure	Durvalumab n=47 participants at risk Durvalumab: 1500 mg administered intravenously (IV) on Day 1 of every 28 day cycle
Blood and lymphatic system disorders Anemia	63.8% 30/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyChronic Microangiopathy	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyDislipidemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyHyperlipidemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Blood and lymphatic system disorders Leukocytosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Atrial fibrillation	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac arrest	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specify3035 with rapid ventricular response	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyAbdominal Aortic Aneurysm	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyAortic Calcification	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyAortic Calcifications	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyAortic Valvue Stenosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyCOPD	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyCardiomegaly	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyCarotid Artery Calcifications	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyCarotid Artery Disease	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyCongestive 3043	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyCoronary Artery Calcification	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyCoronary Artery Calcifications	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyCoronary Artery Disease	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Cardiac disorders - Other, specifyMitral Valve Calcification	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Mitral valve disease	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Pericardial effusion	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Sinus bradycardia	12.8% 6/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Sinus tachycardia	27.7% 13/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Cardiac disorders Tricuspid valve disease	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Ear and labyrinth disorders Hearing impaired	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Endocrine disorders Endocrine disorders - Other, specifyDiabetes	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Endocrine disorders Endocrine disorders - Other, specifyTSH increased	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Endocrine disorders Hyperthyroidism	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Endocrine disorders Hypothyroidism	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Eye disorders Conjunctivitis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Eye disorders Dry eye	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Eye disorders Eye disorders - Other, specifyIschemic Optic Neuropathy	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Eye disorders Eye disorders - Other, specifyOptic Nerve Leak	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Eye disorders Glaucoma	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Abdominal pain	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Bloating	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Constipation	10.6% 5/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Diarrhea	12.8% 6/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Dyspepsia	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Dysphagia	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Flatulence	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastroesophageal reflux disease	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyColonic Diverticulosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyColonic Divertulosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyHaital Hernia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyHiatal Hernia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyPain Right Abdomen/Back	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastrointestinal disorders - Other, specifydivectticulitis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyparaesophageal hernia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Nausea	14.9% 7/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Rectal pain	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Stomach pain	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Gastrointestinal disorders Vomiting	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Chills	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Edema limbs	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Fatigue	42.6% 20/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Fever	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Flu like symptoms	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specify	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyBilateral Inguinal Hernias	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyClaustrophobia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyDecreased breath sounds	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyHiatal Hernia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifySarcoidosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifySchatzki Rings	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyVitamin D deficiency	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyambulatory dysfunction	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyhaloperidol allergy	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyquinine allergy	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifyseasonal allergies	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders General disorders and administration site conditions - Other, specifytramadol allergy	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Hypothermia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Localized edema	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Non-cardiac chest pain	10.6% 5/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
General disorders Pain	23.4% 11/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Hepatobiliary disorders Hepatobiliary disorders - Other, specifyCholelithiasis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Hepatobiliary disorders Hepatobiliary disorders - Other, specifyHepatic Steatosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Bronchial infection	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Hepatitis viral	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Infections and infestations - Other, specifyLip infection (cold sore)	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Infections and infestations - Other, specifyRecurrent 3311s	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Infections and infestations - Other, specifyRecurrent Urinary Tract Infection	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Infections and infestations - Other, specifycrusted rash Right abdomen/back	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Infections and infestations - Other, specifydiverticulitis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Lung infection	12.8% 6/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Mucosal infection	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Skin infection	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Upper respiratory infection	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Infections and infestations Urinary tract infection	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Injury, poisoning and procedural complications Fall	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Injury, poisoning and procedural complications Fracture	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specifyL. gluteal post operative seroma	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Injury, poisoning and procedural complications Spinal fracture	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Activated partial thromboplastin time prolonged	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Alanine aminotransferase increased	19.1% 9/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Alkaline phosphatase increased	29.8% 14/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Aspartate aminotransferase increased	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Blood bilirubin increased	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations CPK increased	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Creatinine increased	21.3% 10/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Electrocardiogram QT corrected interval prolonged	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations GGT increased	12.8% 6/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Hemoglobin increased	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations INR increased	14.9% 7/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specify	19.1% 9/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specify3710	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyChronic Obstructive Pulmonary Disorder	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyDecreased Chloride	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyDecreased Creatinine	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyDyslipidemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyElevated D-dimer	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyHypercholesterolemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyHyperlipidemia	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyLDH Increased	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyPTT increased	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifydecreased albumin	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifydecreased potassium	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifydecreased protein	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyfluid overload (3)	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Investigations - Other, specifyhyperlipidemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Lipase increased	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Lymphocyte count decreased	48.9% 23/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Lymphocyte count increased	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Platelet count decreased	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Serum amylase increased	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations Weight loss	19.1% 9/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Investigations White blood cell decreased	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Anorexia	27.7% 13/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Dehydration	12.8% 6/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypercalcemia	14.9% 7/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hyperglycemia	10.6% 5/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hyperkalemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypermagnesemia	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypernatremia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hyperuricemia	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypoalbuminemia	55.3% 26/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypocalcemia	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypoglycemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypokalemia	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypomagnesemia	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hyponatremia	36.2% 17/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Hypophosphatemia	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifySymptomatic paraneoplastic 3402	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifydecreased appetite	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifyhypercholesterolemia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Arthritis	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Back pain	10.6% 5/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Bone pain	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Chest wall pain	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Flank pain	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Generalized muscle weakness	14.9% 7/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyOsteopenia	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyR. ankle sprain	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifydegenerative joint disease	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifygout	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyjoint pain	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyleg cramps	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyosteo3593	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyright foot drop	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyspinal stenosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Myalgia	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Musculoskeletal and connective tissue disorders Pain in extremity	12.8% 6/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyAdrenal Adenoma	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms - Bilateral renal cysts	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms - Left Maxillary Sinus Mucuous retention Cyst	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyRight Renal Cyst	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyThyroid nodules	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms - benign prostatic hyperplasia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Dizziness	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Dysgeusia	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Facial muscle weakness	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Headache	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Lethargy	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Memory impairment	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Nervous system disorders - Other, specifyAphasia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Nervous system disorders - Other, specifystuttering	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Paresthesia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Peripheral sensory neuropathy	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Seizure	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Nervous system disorders Tremor	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Psychiatric disorders Anxiety	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Psychiatric disorders Confusion	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Psychiatric disorders Depression	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Psychiatric disorders Insomnia	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Psychiatric disorders Psychiatric disorders - Other, specifydementia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Hematuria	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Proteinuria	31.9% 15/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Renal and urinary disorders - Other, specifyDysuria	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Renal calculi	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Urinary frequency	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Urinary retention	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Urinary urgency	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Renal and urinary disorders Urine discoloration	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Reproductive system and breast disorders Gynecomastia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Reproductive system and breast disorders Prostatic obstruction	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specifyBenign Prostate Hyperplasia	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specifyBenign prostatic hyperplasia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specifyProstate Calcifications	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Aspiration	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Atelectasis	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Cough	21.3% 10/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Dyspnea	38.3% 18/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Epistaxis	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Hoarseness	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Hypoxia	19.1% 9/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	12.8% 6/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Pleural effusion	21.3% 10/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Postnasal drip	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Productive cough	10.6% 5/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Pulmonary edema	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify3352	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyAsbestosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyCOPD	6.4% 3/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - COPD	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyEmphaysema	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyNasal Dryness	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyPulmonary Embolism	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifychest tightness	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Sinus disorder	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Sore throat	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Respiratory, thoracic and mediastinal disorders Wheezing	17.0% 8/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Alopecia	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Bullous dermatitis	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Periorbital edema	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Pruritus	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Rash maculo-papular	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Scalp pain	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyFluid filled blister	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyeczema	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyshingles	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyskin lesion right ear	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Surgical and medical procedures Surgical and medical procedures - Other, specify	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Hematoma	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Hot flashes	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Hypertension	31.9% 15/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Hypotension	8.5% 4/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Thromboembolic event	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifyAneurysmal aortic dilatation	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifyAtheroscleratic vascular disease	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifyCoronary Vascular Disease	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifyEndoleak	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifyVascular Calcification	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifyatherosclerotic aortic calcifications	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifycerebral atherosclerosis	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifycoronary artery disease	4.3% 2/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03
Vascular disorders Vascular disorders - Other, specifyperioheral vascular disease	2.1% 1/47 • Adverse Events data were collected for up to 33 months per patient, and up to Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4.03

Additional Information

Barbara Stadterman, Regulatory Specialist Supervisor

UPMC Hillman Cancer Center

Phone: 412-647-5554

Email: stadtermanbm@upmc.edu

Results disclosure agreements

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