Trial Outcomes & Findings for CMP-001 in Combo With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease (NCT NCT03618641)

NCT ID: NCT03618641

Last Updated: 2025-05-14

Results Overview

Distribution of pathologic response in the 30 evaluable patients. Major pathologic response was defined on surgical specimens analyzed by blinded two independent dermatopathologists using immune related pathologic response criteria (irPRC). Residual viable tumor (RVT) (wherein RVT = viable tumor area/total tumor bed area) was calculated depending on the quantity of viable malignant cells on H\&E-stained slides and confirmatory SOX-10-stained representative sections in ambiguous cases; and thresholds defined as follows: complete response (pCR, 0% RVT), major response (pMR, 0%\< RVT ≤10%), partial response (pPR, 10%\< RVT ≤50%), and pNR (RVT \>50%).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: Every 6 weeks from start of study treatment, up to 52 weeks
• Results posted on: 2025-05-14

Participant Flow

Participant milestones

Measure	Nivolumab and CMP-001 Combination Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CMP-001 in Combo With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease

Baseline characteristics by cohort

Measure	Nivolumab and CMP-001 Combination n=34 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.
Age, Continuous	64.5 years n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	19 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	34 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Disease Stage Stage IIIB	15 Participants n=93 Participants
Disease Stage Stage IIIC	16 Participants n=93 Participants
Disease Stage Stage IIID	3 Participants n=93 Participants

PRIMARY outcome

Timeframe: Every 6 weeks from start of study treatment, up to 52 weeks

Population: Patients who completed pre-operative therapy and receive surgery were evaluable for MPR; patients who did not undergo surgery for reasons of disease progression precluding surgery (rapid disease progression) were not evaluable

Distribution of pathologic response in the 30 evaluable patients. Major pathologic response was defined on surgical specimens analyzed by blinded two independent dermatopathologists using immune related pathologic response criteria (irPRC). Residual viable tumor (RVT) (wherein RVT = viable tumor area/total tumor bed area) was calculated depending on the quantity of viable malignant cells on H&E-stained slides and confirmatory SOX-10-stained representative sections in ambiguous cases; and thresholds defined as follows: complete response (pCR, 0% RVT), major response (pMR, 0%< RVT ≤10%), partial response (pPR, 10%< RVT ≤50%), and pNR (RVT >50%).

Outcome measures

Measure	Nivolumab and CMP-001 Combination n=30 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.
Major Pathologic Response Rate (MPR) pCR (0% RVT)	14 Participants
Major Pathologic Response Rate (MPR) pMR (0%< RVT ≤10%)	3 Participants
Major Pathologic Response Rate (MPR) pPR (10%< RVT ≤50)	3 Participants
Major Pathologic Response Rate (MPR) pNR (RVT >50%)	10 Participants

SECONDARY outcome

Timeframe: Up to 31 months

Population: Treated participants evaluable for radiologic response.

Number of patients with Complete response [CR], partial response [PR], or stable disease [SD], per RECIST v1.1 criteria. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD], taking as reference the smallest sum diameters while on study. PD: ≥20% (relative) increase in sum of diameters of target lesions referencing smallest sum on study (includes baseline sum if is smallest on study) and, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of one or more new lesions.

Outcome measures

Measure	Nivolumab and CMP-001 Combination n=31 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.
Radiographic Response Rate Partial Response	14 Participants
Radiographic Response Rate Stable Disease	10 Participants
Radiographic Response Rate Progressive Disease	7 Participants

SECONDARY outcome

Timeframe: Up to 31 months

Population: Treated patients evaluable who were radiologically evaluable.

Length of time from the initiation of treatment that patients survive without recurrence of disease. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of 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 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

Outcome measures

Measure

Nivolumab and CMP-001 Combination n=31 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.

Relapse-Free Survival (RFS)

NA months Interval 22.0 to Median not reached due to low number of events.

SECONDARY outcome

Timeframe: Up to 6 months

Population: Treated patients evaluable who were radiologically evaluable.

Percentage of patients who did not experience disease relapse, 6-months post start of treatment.

Outcome measures

Measure

Nivolumab and CMP-001 Combination n=25 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.

6-month Relapse-free Survival

81 percentage of patients Interval 62.0 to 91.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Treated patients evaluable who were radiologically evaluable.

Percentage of patients who did not experience disease relapse, 12 months post treatment.

Outcome measures

Measure

Nivolumab and CMP-001 Combination n=22 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.

12-month Relapse-free Survival

74 percentage of patients Interval 55.0 to 86.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Treated patients evaluable who were radiologically evaluable.

Percentage of patients who did not experience disease relapse, 24-months post start of treatment.

Outcome measures

Measure

Nivolumab and CMP-001 Combination n=12 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.

24-month Relapse-free Survival

62 percentage of patients Interval 41.0 to 77.0

SECONDARY outcome

Timeframe: Up to 31 months

Population: Trial participants remaining alive.

The length of time from the start of treatment that patients remain alive.

Outcome measures

Measure

Nivolumab and CMP-001 Combination n=31 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.

Overall Survival (OS)

NA months Median not reached due to low number of events.

SECONDARY outcome

Timeframe: Up to 6 months

Population: Trial participants remaining alive.

Percentage of patients that remain alive.

Outcome measures

Measure

Nivolumab and CMP-001 Combination n=31 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.

6-month Overall Survival (OS)

100 percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Trial participants remaining alive.

Percentage of patients that remain alive.

Outcome measures

Measure

Nivolumab and CMP-001 Combination n=27 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.

12-month Overall Survival (OS)

87 percentage of participants Interval 69.0 to 95.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: Trial participants remaining alive.

Percentage of patients that remain alive.

Outcome measures

Measure

Nivolumab and CMP-001 Combination n=16 Participants Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.

24-month Overall Survival (OS)

83 percentage of participants Interval 63.0 to 93.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Circulating and intra-tumoral immune cells, including T-cells (CD8, CD4, Tregs) and antigen-presenting cells (monocytes, macrophages, MDSCs), will be compared pre and post nivolumab and CMP-001 combination treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

TCR clonality/diversity will be compared pre and post nivolumab and CMP-001 combination treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Genetic and transcriptomic signatures will be compared between patients who do and do not respond to study treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Tumor imaging characteristics will be compared between patients who do and do not respond to study treatment.

Outcome measures

Outcome data not reported

Adverse Events

Nivolumab and CMP-001 Combination

Serious events: 8 serious events

Other events: 34 other events

Deaths: 9 deaths

Serious adverse events

Measure	Nivolumab and CMP-001 Combination n=34 participants at risk Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyhypoxemia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Cardiac disorders Restrictive cardiomyopathy	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyBrain Mets	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyfailure to thrive	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Immune system disorders Cytokine release syndrome	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Immune system disorders Immune system disorders - Other, specifyMyasthenia Gravis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Wound infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Injury, poisoning and procedural complications Seroma	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Cardiac troponin I increased	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyinjection site reaction	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Back pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Myositis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyCellulitis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Surgical and medical procedures Surgical and medical procedures - Other, specifyCraniotomy	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0

Other adverse events

Measure	Nivolumab and CMP-001 Combination n=34 participants at risk Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7. Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.
Blood and lymphatic system disorders Anemia	44.1% 15/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyDecreased Lymphocyte Count	11.8% 4/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyDecreased White Blood Cell Count	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyPositive D-Dimer	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specifyprolonged PTT	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Blood and lymphatic system disorders Leukocytosis	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Cardiac disorders Cardiac disorders - Other, specifyTachycardia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Cardiac disorders Cardiac disorders - Other, specifyTachycardia - Intermittent	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Cardiac disorders Chest pain - cardiac	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Cardiac disorders Sinus bradycardia	17.6% 6/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Cardiac disorders Sinus tachycardia	26.5% 9/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Ear and labyrinth disorders Tinnitus	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Endocrine disorders Adrenal insufficiency	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Endocrine disorders Endocrine disorders - Other, specifyincreased Free T3	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Endocrine disorders Hyperthyroidism	20.6% 7/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Endocrine disorders Hypothyroidism	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Eye disorders Blurred vision	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Eye disorders Eye disorders - Other, specifySeeing black spots	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Eye disorders Flashing lights	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Eye disorders Floaters	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Abdominal pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Colitis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Colonic obstruction	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Constipation	11.8% 4/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Diarrhea	35.3% 12/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Dry mouth	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Enterocolitis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Gastritis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyDecreased Appetite	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Hemorrhoidal hemorrhage	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Hemorrhoids	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Mucositis oral	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Nausea	44.1% 15/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Oral pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Rectal hemorrhage	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Gastrointestinal disorders Vomiting	23.5% 8/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Chills	67.6% 23/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Edema face	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Edema limbs	17.6% 6/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Fatigue	52.9% 18/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Fever	55.9% 19/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Flu like symptoms	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyCOVID-19	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyChest Pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyDecreased appetite	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyInjection Site Pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyRigors	11.8% 4/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyedema of neck	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifysore throat	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyswelling at injection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders General disorders and administration site conditions - Other, specifyweakness	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Infusion related reaction	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Injection site reaction	32.4% 11/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Injection site reactionRigors	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Malaise	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Neck edema	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Non-cardiac chest pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
General disorders Pain	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Immune system disorders Cytokine release syndrome	17.6% 6/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Eye infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Infections and infestations - Other, specifyCellulitis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Infections and infestations - Other, specifyinjection site reaction	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Infections and infestations - Other, specifyscalp wound drainage	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Infections and infestations - Other, specifytibial infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Infections and infestations - Other, specifytumor site infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Infections and infestations - Other, specifywound complications	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Joint infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Lung infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Rash pustular	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Sinusitis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Tooth infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Upper respiratory infection	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Vaginal infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Infections and infestations Wound infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Injury, poisoning and procedural complications Fall	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specifySurgical Site Infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specifyinfusion related reaction	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Injury, poisoning and procedural complications Seroma	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Activated partial thromboplastin time prolonged	20.6% 7/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Alanine aminotransferase increased	11.8% 4/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Alkaline phosphatase increased	11.8% 4/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Aspartate aminotransferase increased	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Blood bilirubin increased	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Creatinine increased	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Hemoglobin increased	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations INR increased	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyBUN Increased	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyBlood Lactate Dehydrogenase Increased	29.4% 10/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyBlood bilirubin decrease	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyDecreased T4	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyDecreased protein	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyElevated LDH	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyElevated Platelets	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyFree T4 Increased	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyHypochloremia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyIncrease Temperature	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyIncreased Free T4	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyIncreased LDH	29.4% 10/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyIncreased Platelets	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyIncreased Prothrombin Time	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyIncreased Uric Acid	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyLDH Increased	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyRight Axilla Pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyThyroid Stimulating Hormone Increased	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifydecreased TSH	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased BUN	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased Creatinine	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased D dimer	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased INR	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased PT	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased PTT	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased T3	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased ldh	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased protein	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyincreased temp	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyinjection site swelling	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyplatelet increased	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifyrigors	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Investigations - Other, specifysoreness at injection site	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Lymphocyte count decreased	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Neutrophil count decreased	23.5% 8/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Platelet count decreased	20.6% 7/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Weight gain	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations Weight loss	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Investigations White blood cell decreased	17.6% 6/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Anorexia	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypercalcemia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hyperglycemia	17.6% 6/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hyperkalemia	11.8% 4/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypermagnesemia	20.6% 7/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypernatremia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hyperuricemia	20.6% 7/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypoalbuminemia	26.5% 9/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypocalcemia	17.6% 6/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypoglycemia	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypokalemia	23.5% 8/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypomagnesemia	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hyponatremia	70.6% 24/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Hypophosphatemia	47.1% 16/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifyIncrease in phosphorus	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifydecreased appetite	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifydecreased protein	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifyhypouricemia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifyloss of appetite	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Arthralgia	23.5% 8/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Arthritis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Back pain	29.4% 10/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyIntermittent Back Pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Joint Range of Motion Decreased - R Ankle	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyL Ankle Reconstruction	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyLeft hip pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyLeft shoulder pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifySpinal Stenosis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyToothache	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyankle injury	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyjoint pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifymuscle cramping in legs	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifymuscle pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyright arm swelling	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifysprained ankle	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Myalgia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Neck pain	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Musculoskeletal and connective tissue disorders Pain in extremity	20.6% 7/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Dizziness	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Dysgeusia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Headache	29.4% 10/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Movements involuntary	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Nervous system disorders - Other, specifyRight Facial Drop	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Nervous system disorders - Other, specifyfacial droop - Right Eye	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Nervous system disorders - Other, specifyright sided facial droop	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Paresthesia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Peripheral motor neuropathy	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Peripheral sensory neuropathy	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Syncope	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Nervous system disorders Tremor	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Psychiatric disorders Anxiety	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Psychiatric disorders Confusion	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Psychiatric disorders Depression	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Psychiatric disorders Insomnia	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Renal and urinary disorders Hematuria	23.5% 8/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Renal and urinary disorders Proteinuria	20.6% 7/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Renal and urinary disorders Renal and urinary disorders - Other, specifyFluid Overload	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Renal and urinary disorders Renal and urinary disorders - Other, specifyGlycosuria	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Renal and urinary disorders Urinary tract pain	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Renal and urinary disorders Urine discoloration	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Atelectasis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Cough	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Dyspnea	17.6% 6/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyCOPD	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyPneumonia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyhypoxemia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Respiratory, thoracic and mediastinal disorders Sore throat	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Alopecia	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Erythema multiforme	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Photosensitivity	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Pruritus	14.7% 5/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Rash acneiform	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Rash maculo-papular	11.8% 4/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyCellulitis	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyDry Skin (hands)	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyRash	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifySquamous Cell	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyhives	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifymouth/nasal sores	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyrash at injection site	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyredness to neck	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyskin infection	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Skin and subcutaneous tissue disorders Skin hypopigmentation	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Vascular disorders Flushing	5.9% 2/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Vascular disorders Hematoma	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Vascular disorders Hypertension	64.7% 22/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Vascular disorders Hypotension	8.8% 3/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Vascular disorders Lymphedema	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
Vascular disorders Thromboembolic event	2.9% 1/34 • Adverse Events monitored up to 31 months, All-Cause Mortality monitored up to 31 months Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0

Additional Information

Barbara Stadterman, MPH, MCCR; CRS Regulatory 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