Trial Outcomes & Findings for Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery (NCT NCT01206140)

NCT ID: NCT01206140

Last Updated: 2015-10-05

Results Overview

Progression-free survival was estimated using the product-limit method of Kaplan and Meier. Progression wasl evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: Until disease progression or death, up to 4.5 years
• Results posted on: 2015-10-05

Participant Flow

Participant milestones

Measure	Arm I (Selumetinib) Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO	Arm II (Selumetinib and Temsirolimus) Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO Temsirolimus: Given IV
Overall Study STARTED	35	35
Overall Study COMPLETED	34	35
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Arm I (Selumetinib) Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO	Arm II (Selumetinib and Temsirolimus) Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO Temsirolimus: Given IV
Overall Study Deemed ineligible due to incorrect diag.	1	0

Baseline Characteristics

Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Measure	Arm I (Selumetinib) n=34 Participants Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO	Arm II (Selumetinib and Temsirolimus) n=35 Participants Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO Temsirolimus: Given IV	Total n=69 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	56 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	25 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	35 participants n=7 Participants	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Until disease progression or death, up to 4.5 years

Progression-free survival was estimated using the product-limit method of Kaplan and Meier. Progression wasl evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.

Outcome measures

Measure	Arm I (Selumetinib) n=34 Participants Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO	Arm II (Selumetinib and Temsirolimus) n=35 Participants Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO Temsirolimus: Given IV
Progression-free Survival	1.8 months Interval 0.5 to 1.8	3.7 months Interval 1.6 to 9.3

SECONDARY outcome

Timeframe: Evaluated for response after every two cycles, up to 4.5 years.

Response evaluated using the Choi criteria. CR - disappearance of all lesions and no new lesions; PR - a decrease in size (the sum of longest diameters of target lesions as defined in RECIST) of 10% or more or a decrease in tumor density (HU) of 15% or more on CT and no new lesions and no obvious progression of nonmeasurable disease; SD - does not meet the criteria for CR, PR, or PD and no symptomatic deterioration attributed to tumor progression; PD - an increase in tumor size of 10% or more and does not meet criteria of PR by tumor density (HU) on CT or new lesions or new intratumoral nodules or increase in the size of the existing intratumoral nodules. Objective response = CR+PR.

Outcome measures

Measure	Arm I (Selumetinib) n=34 Participants Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO	Arm II (Selumetinib and Temsirolimus) n=35 Participants Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO Temsirolimus: Given IV
Number of Participants With Objective Response	5 participants	4 participants

SECONDARY outcome

Timeframe: Four months

Progression-free survival rate was calculated using the survival distribution function, and 95% confidence limits were calculated using the log-log transformation. Progression was defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.

Outcome measures

Measure	Arm I (Selumetinib) n=34 Participants Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO	Arm II (Selumetinib and Temsirolimus) n=35 Participants Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO Temsirolimus: Given IV
4 -Month Progression-free Survival Rate.	24 percent of participants Interval 9.0 to 40.0	24 percent of participants Interval 9.0 to 39.0

Adverse Events

Arm I (Selumetinib)

Serious events: 23 serious events

Other events: 33 other events

Deaths: 0 deaths

Arm II (Selumetinib and Temsirolimus)

Serious events: 18 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Selumetinib) n=34 participants at risk Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO	Arm II (Selumetinib and Temsirolimus) n=35 participants at risk Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO Temsirolimus: Given IV
Blood and lymphatic system disorders Anemia	8.8% 3/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial flutter	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac arrest	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Volume overload	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Conjunctivitis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	11.8% 4/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Bloating	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Colitis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	5.9% 2/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Duodenal fistula	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Duodenal hemorrhage	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Duodenal obstruction	5.9% 2/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastric hemorrhage	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastric ulcer	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ileus	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema face	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	5.9% 2/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Malaise	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders vaginal mucositis	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Biliary tract infection	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bladder infection	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bronchial infection	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	2.9% 1/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Device related infection	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Endocarditis infective	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Paronychia	8.8% 3/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Penile infection	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sepsis	5.9% 2/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Unknown source but positive blood cultur	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Viral gastroenteritis	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations left groin area	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Hip fracture	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	5.9% 2/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Ejection fraction decreased	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	11.8% 4/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 4 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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) Progressive disease	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Depressed level of consciousness	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Genital edema	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Pneumothorax	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Surgical and medical procedures Spinal cord compression	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Surgical and medical procedures T5 Laminectomy	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	17.6% 6/34 • Number of events 18 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Lymphedema	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Arm I (Selumetinib) n=34 participants at risk Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO	Arm II (Selumetinib and Temsirolimus) n=35 participants at risk Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22. Laboratory Biomarker Analysis: Correlative studies Selumetinib: Given PO Temsirolimus: Given IV
Blood and lymphatic system disorders Anemia	73.5% 25/34 • Number of events 98 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	77.1% 27/35 • Number of events 73 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrioventricular block first degree	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Murmer	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericardial effusion	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	2.9% 1/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	20.6% 7/34 • Number of events 14 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 5/35 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders pedal edema	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear pain	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Middle ear inflammation	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Cushingoid	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Hyperthyroidism	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blepharitis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blurred vision	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Cataract	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Conjunctivitis	2.9% 1/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye pain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Floaters	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Photophobia	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Scleral disorder	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders disconjugate gaze	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders drainage	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders left eye conjunctival hemorrhage	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders right eye conjunctival hemorrhage	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders swollen left eye	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	17.6% 6/34 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	35.3% 12/34 • Number of events 18 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Bloating	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Colonic hemorrhage	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	50.0% 17/34 • Number of events 35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.4% 11/35 • Number of events 14 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dark Stool	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	52.9% 18/34 • Number of events 31 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 15/35 • Number of events 22 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	17.6% 6/34 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 6/35 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	8.8% 3/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal hemorrhage	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal pain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal ulcer	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	14.7% 5/34 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastric ulcer	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal pain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gum Abscess	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	44.1% 15/34 • Number of events 30 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	68.6% 24/35 • Number of events 46 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	64.7% 22/34 • Number of events 51 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.1% 13/35 • Number of events 18 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.9% 8/35 • Number of events 9 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal fistula	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal mucositis	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal pain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	5.9% 2/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Toothache	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	52.9% 18/34 • Number of events 40 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	34.3% 12/35 • Number of events 15 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders mucoid diarrhea	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	26.5% 9/34 • Number of events 12 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.9% 8/35 • Number of events 16 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema face	17.6% 6/34 • Number of events 12 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.4% 11/35 • Number of events 12 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	50.0% 17/34 • Number of events 52 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 14/35 • Number of events 24 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema trunk	2.9% 1/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	82.4% 28/34 • Number of events 93 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	51.4% 18/35 • Number of events 35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	23.5% 8/34 • Number of events 15 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.9% 8/35 • Number of events 11 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Gait disturbance	8.8% 3/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Infusion related reaction	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Malaise	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Night Sweats	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	20.6% 7/34 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	14.7% 5/34 • Number of events 15 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders dry nose	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders night sweats	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders stent replaced - obstructed by tumor	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Allergic reaction	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Eye infection	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Mucosal infection	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Papulopustular rash	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Paronychia	5.9% 2/34 • Number of events 10 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Penile infection	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pharyngitis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations R big toe infection	2.9% 1/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sinusitis	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 9 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 5/35 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Thrush	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Tooth infection	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Vaginal infection	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations infected necrotic tumor	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time pr	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	32.4% 11/34 • Number of events 24 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 10/35 • Number of events 13 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	26.5% 9/34 • Number of events 27 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 14/35 • Number of events 29 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	55.9% 19/34 • Number of events 53 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	51.4% 18/35 • Number of events 28 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	8.8% 3/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations CD4 lymphocytes decreased	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations CPK increased	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Cholesterol high	29.4% 10/34 • Number of events 48 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.1% 13/35 • Number of events 29 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	11.8% 4/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 11 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	5.9% 2/34 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 5/35 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lipase increased	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	17.6% 6/34 • Number of events 12 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 14/35 • Number of events 38 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count increased	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	32.4% 11/34 • Number of events 25 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 14/35 • Number of events 44 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	44.1% 15/34 • Number of events 42 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	68.6% 24/35 • Number of events 49 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations QTc prolonged	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	5.9% 2/34 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	14.7% 5/34 • Number of events 11 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 7 • Adverse events collected over a period of 28 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	35.3% 12/34 • Number of events 42 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 14/35 • Number of events 43 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations alanine aminotransferase decreased	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations eosinophilia	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations ionized calcium	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Acidosis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	41.2% 14/34 • Number of events 34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 15/35 • Number of events 21 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Chloride increased	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	17.6% 6/34 • Number of events 16 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.1% 13/35 • Number of events 27 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypernatremia	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	32.4% 11/34 • Number of events 36 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.1% 13/35 • Number of events 26 • Adverse events collected over a period of 28 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	58.8% 20/34 • Number of events 37 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	51.4% 18/35 • Number of events 37 • Adverse events collected over a period of 28 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	20.6% 7/34 • Number of events 14 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.4% 11/35 • Number of events 16 • Adverse events collected over a period of 28 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	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 28 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	23.5% 8/34 • Number of events 14 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.1% 13/35 • Number of events 28 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	11.8% 4/34 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	32.4% 11/34 • Number of events 34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.7% 9/35 • Number of events 13 • Adverse events collected over a period of 28 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	20.6% 7/34 • Number of events 11 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Increased LDH	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders LDH increased	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	20.6% 7/34 • Number of events 50 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders increased LDH	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	23.5% 8/34 • Number of events 14 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 6/35 • Number of events 8 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 16 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 body aches	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 4 • Adverse events collected over a period of 28 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 lower limb	5.9% 2/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 upper limb	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 11 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 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	8.8% 3/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 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	35.3% 12/34 • Number of events 34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.7% 9/35 • Number of events 13 • Adverse events collected over a period of 28 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 Pelvic soft tissue necrosis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Weakness	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 spasm, left hip	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 (L) w/ cough	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 twitching	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	26.5% 9/34 • Number of events 36 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ataxia	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Concentration impairment	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Depressed level of consciousness	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	11.8% 4/34 • Number of events 16 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysarthria	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysgeusia	17.6% 6/34 • Number of events 17 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 6/35 • Number of events 9 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Facial muscle weakness	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	20.6% 7/34 • Number of events 9 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders L facial palsy	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Lethargy	17.6% 6/34 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Myelitis	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neuralgia	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	11.8% 4/34 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 3 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Phantom pain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Presyncope	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Radiculitis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Somnolence	8.8% 3/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Spasticity	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Tremor	5.9% 2/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	14.7% 5/34 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 5/35 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	17.6% 6/34 • Number of events 12 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	32.4% 11/34 • Number of events 21 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 6/35 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Libido decreased	8.8% 3/34 • Number of events 11 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Lucid per physical exam	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Restlessness	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Suicidal ideation	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Acute kidney injury	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Nocturia	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	14.7% 5/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal calculi	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 incontinence	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 obstruction	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urine discoloration	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Erectile dysfunction	2.9% 1/34 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Genital edema	5.9% 2/34 • Number of events 9 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Pelvic pain	8.8% 3/34 • Number of events 11 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Penile pain	2.9% 1/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Testicular pain	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 dryness	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 mucositis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Atelectasis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Bronchospasm	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	41.2% 14/34 • Number of events 41 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 7/35 • Number of events 9 • Adverse events collected over a period of 28 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	44.1% 15/34 • Number of events 39 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.7% 9/35 • Number of events 16 • Adverse events collected over a period of 28 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	14.7% 5/34 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 7/35 • Number of events 7 • Adverse events collected over a period of 28 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 Hiccups	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 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 Laryngeal inflammation	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 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	8.8% 3/34 • Number of events 15 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 28 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 Pleuritic pain	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Pneumonitis	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Pneumothorax	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Postnasal drip	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 7 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 2 • Adverse events collected over a period of 28 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 Sleep apnea	2.9% 1/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 Sneezing	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 4 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 4 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 26 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 6/35 • Number of events 11 • Adverse events collected over a period of 28 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	17.6% 6/34 • Number of events 23 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 6/35 • Number of events 11 • Adverse events collected over a period of 28 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	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.7% 2/35 • Number of events 3 • Adverse events collected over a period of 28 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 Hyperhidrosis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 discoloration	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 loss	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Pain of skin	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Palmar-plantar erythrodysesthesia syndro	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Periorbital edema	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 4 • Adverse events collected over a period of 28 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	11.8% 4/34 • Number of events 5 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.7% 9/35 • Number of events 19 • Adverse events collected over a period of 28 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	64.7% 22/34 • Number of events 67 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.6% 17/35 • Number of events 40 • Adverse events collected over a period of 28 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	17.6% 6/34 • Number of events 8 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.9% 8/35 • Number of events 12 • Adverse events collected over a period of 28 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 hyperpigmentation	5.9% 2/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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	5.9% 2/34 • Number of events 10 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 Telangiectasia	2.9% 1/34 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 burning in armpits	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 cellulitis	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 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 cut on palm	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 folliculitis	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 ingrown toe nail	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 pin point rash/non red/dry skin	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 pin point rash/non-red/dry skin	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 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 redness and liquid in stump area	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 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 fissures on finger pads	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Flushing	0.00% 0/34 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 2 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	5.9% 2/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	55.9% 19/34 • Number of events 81 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	34.3% 12/35 • Number of events 33 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	8.8% 3/34 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.9% 1/35 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Lymphedema	2.9% 1/34 • Number of events 10 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 4/35 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	5.9% 2/34 • Number of events 6 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.6% 3/35 • Number of events 3 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders venous stasis changes, legs	2.9% 1/34 • Number of events 1 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/35 • Adverse events collected over a period of 28 months "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: CCCP@coh.org

Results disclosure agreements

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

Restriction type: LTE60