Trial Outcomes & Findings for Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer (NCT NCT02226276)

NCT ID: NCT02226276

Last Updated: 2025-02-18

Results Overview

Relationship between patient best response to T-DM1 and measured tumor uptake of 64Cu-DOTA-trastuzumab employed a t-test with a 0.05 two-sided significance level comparing average uptake in responsive vs non-responsive patients. Tumor uptake measured as SUV defined as SUV = AC(tsc) Wb /\[Dinj exp(-λ(tsc - tinj)\] , where AC(tsc) is the activity concentration in the volume of interest (VOI, e. g., a tumor), Wb is the patient's body weight, Dinj is the activity injected at time tinj, and λ is the decay constant for the injected radioisotope. AC(tsc) is determined from the spatial density of counts acquired from the VOI. Tumor uptake was measured in terms of maximum voxel standardized uptake value, SUVmax. Response assessment adhered to Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST 1.0).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-02-18

Participant Flow

Participant milestones

Measure	Diagnostic (Copper Cu 64-DOTA-trastuzumab PET) Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV (45 mg) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV (\<15 mCi; protein dose 5 mg) and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV (3.6 mg/kg) every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT trastuzumab: Given IV copper Cu 64-DOTA-trastuzumab: Given IV positron emission tomography: Undergo copper Cu-DOTA-trastuzumab PET ado-trastuzumab emtansine: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

Baseline characteristics by cohort

Measure	Diagnostic (Copper Cu 64-DOTA-trastuzumab PET) n=10 Participants Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV (45 mg) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV (\<15 mCi; protein dose 5 mg) and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV (3.6 mg/kg) every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT trastuzumab: Given IV copper Cu 64-DOTA-trastuzumab: Given IV positron emission tomography: Undergo copper Cu-DOTA-trastuzumab PET ado-trastuzumab emtansine: Given IV laboratory biomarker analysis: Correlative studies
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Relationship between patient best response to T-DM1 and measured tumor uptake of 64Cu-DOTA-trastuzumab employed a t-test with a 0.05 two-sided significance level comparing average uptake in responsive vs non-responsive patients. Tumor uptake measured as SUV defined as SUV = AC(tsc) Wb /[Dinj exp(-λ(tsc - tinj)] , where AC(tsc) is the activity concentration in the volume of interest (VOI, e. g., a tumor), Wb is the patient's body weight, Dinj is the activity injected at time tinj, and λ is the decay constant for the injected radioisotope. AC(tsc) is determined from the spatial density of counts acquired from the VOI. Tumor uptake was measured in terms of maximum voxel standardized uptake value, SUVmax. Response assessment adhered to Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST 1.0).

Outcome measures

Measure

Diagnostic (Copper Cu 64-DOTA-trastuzumab PET) n=10 Participants Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV (45 mg) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV (\<15 mCi; protein dose 5 mg) and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV (3.6 mg/kg) every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT trastuzumab: Given IV copper Cu 64-DOTA-trastuzumab: Given IV positron emission tomography: Undergo copper Cu-DOTA-trastuzumab PET ado-trastuzumab emtansine: Given IV laboratory biomarker analysis: Correlative studies

Relationship Between Average Tumor Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response

3.1 SUVmax (g/mL) Interval 0.5 to 7.0

PRIMARY outcome

Timeframe: Up to 1 year

Relationship between patient best response to T-DM1 and measured tumor uptake of 64Cu-DOTA-trastuzumab employed a t-test with a 0.05 two-sided significance level comparing minimum uptake in responsive vs non-responsive patients. Tumor uptake measured as SUV defined as SUV = AC(tsc) Wb /[Dinj exp(-λ(tsc - tinj)] , where AC(tsc) is the activity concentration in the volume of interest (VOI, e. g., a tumor), Wb is the patient's body weight, Dinj is the activity injected at time tinj, and λ is the decay constant for the injected radioisotope. AC(tsc) is determined from the spatial density of counts acquired from the VOI. Tumor uptake was measured in terms of minimum voxel standardized uptake value, SUVmin. Response assessment adhered to Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST 1.0).

Outcome measures

Measure

Diagnostic (Copper Cu 64-DOTA-trastuzumab PET) n=10 Participants Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV (45 mg) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV (\<15 mCi; protein dose 5 mg) and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV (3.6 mg/kg) every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT trastuzumab: Given IV copper Cu 64-DOTA-trastuzumab: Given IV positron emission tomography: Undergo copper Cu-DOTA-trastuzumab PET ado-trastuzumab emtansine: Given IV laboratory biomarker analysis: Correlative studies

Relationship Between Tumor Minimum Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response

5.1 SUVmin (g/mL) Interval 3.0 to 7.0

Adverse Events

Diagnostic (Copper Cu 64-DOTA-trastuzumab PET)

Serious events: 5 serious events

Other events: 10 other events

Deaths: 2 deaths

Serious adverse events

Measure	Diagnostic (Copper Cu 64-DOTA-trastuzumab PET) n=10 participants at risk Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV (45 mg) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV (\<15 mCi; protein dose 5 mg) and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV (3.6 mg/kg) every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT trastuzumab: Given IV copper Cu 64-DOTA-trastuzumab: Given IV positron emission tomography: Undergo copper Cu-DOTA-trastuzumab PET ado-trastuzumab emtansine: Given IV laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Abdominal infection	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Lung infection	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Hallucinations	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Diagnostic (Copper Cu 64-DOTA-trastuzumab PET) n=10 participants at risk Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV (45 mg) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV (\<15 mCi; protein dose 5 mg) and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV (3.6 mg/kg) every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression. fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT computed tomography: Undergo fludeoxyglucose F 18 PET/CT trastuzumab: Given IV copper Cu 64-DOTA-trastuzumab: Given IV positron emission tomography: Undergo copper Cu-DOTA-trastuzumab PET ado-trastuzumab emtansine: Given IV laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Anemia	90.0% 9/10 • Number of events 64 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders bleeding from gums	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders bleeding from hard palate	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders bleeding from the hard palate	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders intermittent epistaxis - R nostril	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders intermittent nosebleed	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders lump in the R axilla	10.0% 1/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders petechie	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders thrombocytopenia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Aortic valve disease	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	50.0% 5/10 • Number of events 34 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Ventricular tachycardia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders intermittent PVCs to auscultation	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders intermittent tachycardia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Vertigo	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Cushingoid	20.0% 2/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Hypothyroidism	10.0% 1/10 • Number of events 42 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders low cortisol level	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders low cortisol level (under investigation with endocrinology)	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blurred vision	10.0% 1/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Decreased Peripheral Vision	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Decreased Peripheral dcreased	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Decreased Peripherla Vision	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Decreased Peropheral Vision	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Decreased peripherla vision	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eyelid function disorder	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Photophobia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Visual Symptoms	10.0% 1/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Visual symptoms - only when she is tired	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders decreased peripheral vision	10.0% 1/10 • Number of events 10 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders decreased peripheral vision after sugery	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders decreased peripheral vision after surgery	10.0% 1/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders decreased peripheral vision after the 2/8 surgery	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders decreased peripheral vision after the surger	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders decreased peripheral vision after the surgery	10.0% 1/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders dicreased peripheral vision	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders hyperropia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders intermittent blurry eye	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders intermittent blurry eye (when reading for a long time)	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders intermittent blurry eye when reads for long time	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders photosensitivity	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders shaking of eyes during C4 infusion	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders shaking of eyes during trastuzumab emtansine infusion	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders shaking of eyes during trastuzumab emtansive	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders stye	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders tired eyes - when reads for a long time	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders tired eyes when reads for a long time	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders visual symptoms	10.0% 1/10 • Number of events 16 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders visual symptoms (only when tired)	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders visual symptoms - only when tired	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders visual symptoms only when tired	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders whipple in the left eye	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	20.0% 2/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Bloating	20.0% 2/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	70.0% 7/10 • Number of events 32 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	40.0% 4/10 • Number of events 23 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	30.0% 3/10 • Number of events 19 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	40.0% 4/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Heartburn	10.0% 1/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	70.0% 7/10 • Number of events 75 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Tongue feels raw, Hurting	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Tongue feels raw, hurting	10.0% 1/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Tounge feels raw, Hurting	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	70.0% 7/10 • Number of events 17 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders decreased appetite	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders epigastric discomfort	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders flactuating appetite after Keppra increased	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders glossitis	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders heartburn	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders increased appetite	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders increased thirst	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders indigestion	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders intermittent constipation	30.0% 3/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders intermittent diarrhea	20.0% 2/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders intermittent nausea	20.0% 2/10 • Number of events 15 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders intermittent nausea - after Keppra increased	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders intermittent nausea after Keppra increased	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders intermittent rectal bleeding	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders intermittent vomiting	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders intermittent vomitting	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders low appetite	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders occasional blood in stool	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders occasional blood in stool while having hard stool	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders occasional constipation	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders plaque small white side of tongue	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders rectal bleeding	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders red, raw tongue	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders small white plaque L side of tongue	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders tenderness in mid-left abdomen w touch	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders tenderness in mid-left abdomen w/ touch	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders tongue feels raw, hurting	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders unable to eruct	10.0% 1/10 • Number of events 9 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	30.0% 3/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	100.0% 10/10 • Number of events 117 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	20.0% 2/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu like symptoms	30.0% 3/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Malaise	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Neck edema	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Non-cardiac chest pain	20.0% 2/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders abscess	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders low-grade temperature	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Rhinitis infective	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sinusitis	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	20.0% 2/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	50.0% 5/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations low grade temperature	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations oral thrush	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations shingles	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations suspected bacteremia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations yeast infection	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	20.0% 2/10 • Number of events 9 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Dermatitis radiation	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Fracture	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	50.0% 5/10 • Number of events 24 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	70.0% 7/10 • Number of events 67 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	80.0% 8/10 • Number of events 71 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Electrocardiogram QT corrected interval	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hemoglobin increased	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	50.0% 5/10 • Number of events 19 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	30.0% 3/10 • Number of events 13 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	80.0% 8/10 • Number of events 95 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	20.0% 2/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations White blood cell decreased	40.0% 4/10 • Number of events 34 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	70.0% 7/10 • Number of events 18 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	20.0% 2/10 • Number of events 38 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	40.0% 4/10 • Number of events 19 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	20.0% 2/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypermagnesemia	20.0% 2/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	60.0% 6/10 • Number of events 19 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	30.0% 3/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	60.0% 6/10 • Number of events 23 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	80.0% 8/10 • Number of events 35 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Obesity	10.0% 1/10 • Number of events 20 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders occasional night sweats	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Avascular necrosis	10.0% 1/10 • Number of events 28 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	40.0% 4/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	20.0% 2/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Flank pain	20.0% 2/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	20.0% 2/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint range of motion decreased cervical	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L ankle swelling and pain	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L big toe bends in toward other toes	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L big toe bends in towards other toes	10.0% 1/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L big toe bends toward other toes	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L big toe bends towards other toes	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L hand is curled inward	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L shoulder and L middle finger joint pain	10.0% 1/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L shoulder pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders L sided limp	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 2/10 • Number of events 10 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Neck pain	30.0% 3/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Osteopenia	10.0% 1/10 • Number of events 9 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 5/10 • Number of events 13 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders R elbow pain	10.0% 1/10 • Number of events 13 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders R shoulder and arm pain	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders R shoulder pain	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders R shoulder, arm pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders R shoulder/arm pain	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders arthritis R shoulder	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders avascular necrosis L humerus	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders bilateral elbow pain	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders bilateral shoulder and neck pain	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders bunionette	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders car accident injuries	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders car accident on 6/19/2018	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders cramping	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility and pain in L arm	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility and pain in left arm/difficulty making fi	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility, pain left arm	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility, pain L arm	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility, pain L arm, difficulty making fist w L h	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility, pain L arm/difficulty making fist L hand	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility, pain in L arm	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility, pain left arm, difficulty making fist w	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility, pain left arm, difficulty making fist wi	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility/pain L arm, difficulty making fist L hand	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility/pain left arm, difficulty making fist wit	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders decreased mobility/pain left arm/difficulty making fist with	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders difficulty making fist with L arm	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders difficulty making fist with L hand	10.0% 1/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders dupuytrens contracture status post surgery	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders intermittent L should pain - movement dependent	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders intermittent L shoulder pain - movement dependent	10.0% 1/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders intermittent L shoulder pain movement dependent	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders intermittent bilateral rib pain	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders intermittent lower back pain	10.0% 1/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders left shoulder pain	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders mid-back pain	10.0% 1/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders muscle cramps - both legs and back	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders neck stiffness	10.0% 1/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders osteopenia	10.0% 1/10 • Number of events 23 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders overall myalgia and body stiffness	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders pain and decreased mobility both arms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders pain and decreased mobility in both arms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders pain and swelling - back of L knee	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders pain in neck and shoulders	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders pain in the thighs (front of thighs and glutes)	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders pain in the thighs - front of thighs and glutes	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders right elbow pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders rotator cuff injury	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders rotator cuff injury R arm	10.0% 1/10 • Number of events 14 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders shoulder pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders stiffness in knee and back	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders swollen area of R side of R foot	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders swollen area on R side of R foot	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ataxia	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	50.0% 5/10 • Number of events 14 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysgeusia	20.0% 2/10 • Number of events 12 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysphasia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	40.0% 4/10 • Number of events 55 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L arm - pain of full abduction	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L arm - pain on full abduction	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L hand curled inward	10.0% 1/10 • Number of events 13 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L side hemoplegia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L side weak (as per getting up from squat, dragging)	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L sided hemiparesis	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L sided hemiplegia	10.0% 1/10 • Number of events 14 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L sided hemoplegia	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L upper eyelid ptosis	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Lethargy	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Memory impairment	10.0% 1/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	20.0% 2/10 • Number of events 22 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	80.0% 8/10 • Number of events 62 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Recurrent laryngeal nerve palsy	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Somnolence	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent dizziness w/ position change - preexisting as p	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent dizziness w/ position change)	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent headache	20.0% 2/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent headache (2 weeks after TX)	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent headache (only scar pain when bends, lean over)	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent headache (only scar pain, when bends, lean over	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent sensitivity - feet - bottoms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent sensitivity - feet bottoms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders intermittent sensitivity feet botoms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders l sided hemiplegia	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders left sided hemiplegia	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders migraine	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders pain at the base of the neck	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders sensitivity - feet bottoms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders sensory neuropathy L arm	10.0% 1/10 • Number of events 17 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders sensory neuropathy left arm	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders sensory neurophathy left arm	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders vocal cord paralysis	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Agitation	20.0% 2/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	30.0% 3/10 • Number of events 31 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	10.0% 1/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	20.0% 2/10 • Number of events 25 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders anxiety re new brain lesions	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders emotional distress	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Proteinuria	20.0% 2/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders UTI symptoms (dysuria, abdominal pain, changes in UA)	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders UTI symptoms - dysuria, abdominal pain, changes in UA)	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary retention	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary tract pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders dysuria	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders hot urine	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders polyuria	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Irregular menstruation	20.0% 2/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal hemorrhage	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders candidiasis	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	20.0% 2/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	40.0% 4/10 • Number of events 29 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 5/10 • Number of events 15 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	20.0% 2/10 • Number of events 44 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	30.0% 3/10 • Number of events 9 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Laryngospasm	10.0% 1/10 • Number of events 12 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	30.0% 3/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders URI	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	10.0% 1/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders allergic rhinitis	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders allergic symptoms	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders allergies - patient reported	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders asthmatic bronchtis	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders chest congestion	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders cold symptoms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders crackles in LLL (both insp and expiration)	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders decreased O2 saturation	10.0% 1/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders decreased oxygen saturation	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders dry cough	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders dry cough (chronic as per patient), noted in the CRU	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders inspiratory crackles - left posterior lung base	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders intermittent chest discomofort	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders intermittent drippy nose following TX	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders intermittent drippy nose following treatment	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders intermittent dyspnea (only when activity and speech at the s	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders intermittent dyspnea only when activity and speech at the sa	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders occasional cough	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders occasional cough (provoked by food smell as per patient)	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders occasional cough provoked by food smells as per patient	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders occasional sputum build up in the throat	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders occasional sputum build up in the troat	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders possible small airway dysfunction	10.0% 1/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders possible small airways dysfunction	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders productive cough w/ white or clear phlegm	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders productive cough with white or clear phlegm	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders rales and wheezes in LLL	10.0% 1/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders rhinorrhea	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders rhnorrhea	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders scattered wheezes R upper lobe	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders scattered wheezes in R upper lob	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders scattered wheezes in R upper lobe	10.0% 1/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders scattered wheezes in the R upper lobe	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders small airway dysfunction	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders sounds while sleeping	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders sputum build up in the throat	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders wheezing after excercise	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders wheezing after exercise	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders wheezing/cracking breath w/ expiration	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders worsening of L mid and lower lobe interst and ground glass o	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders worsening of L mid and lower lobe lung interst and ground gl	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	40.0% 4/10 • Number of events 12 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail ridging	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Peeling of skin on feet	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Petechiae	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Photosensitivity	10.0% 1/10 • Number of events 34 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash acneiform	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin ulceration	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Urticaria	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders capillary hemangioma	10.0% 1/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders erythema in response to RX therapy	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders occasional pain in the incision area	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders occasional soreness to the incision area	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders occasional soreness to the incison area	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders petechiae	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders scabs and bruises on the back of L arm	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders skin lesions from cupping	10.0% 1/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders skin lessions from cupping	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders skin peeling at feet	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders skin spot removed from the nose	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders small raised bump on the R inner thigh	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders sores on fingers	10.0% 1/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders weak nails	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Social circumstances menopausal like symptoms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	90.0% 9/10 • Number of events 119 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	10.0% 1/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Lymphedema	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: pfrankel@coh.org

Results disclosure agreements

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