Trial Outcomes & Findings for Sorafenib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer (NCT NCT00114244)

NCT ID: NCT00114244

Last Updated: 2015-01-14

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan, MRI, X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: Every 6 weeks.
• Results posted on: 2015-01-14

Participant Flow

Participant milestones

Measure	Arm I (Sorafenib Tosylate) Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. sorafenib tosylate: Given PO laboratory biomarker analysis: Correlative studies	Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15. sorafenib tosylate: Given PO gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	15	37
Overall Study COMPLETED	13	30
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Measure	Arm I (Sorafenib Tosylate) Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. sorafenib tosylate: Given PO laboratory biomarker analysis: Correlative studies	Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15. sorafenib tosylate: Given PO gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Overall Study Adverse Event	2	5
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Sorafenib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Measure	Arm I (Sorafenib Tosylate) n=15 Participants Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. sorafenib tosylate: Given PO laboratory biomarker analysis: Correlative studies	Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) n=37 Participants Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15. sorafenib tosylate: Given PO gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies	Total n=52 Participants Total of all reporting groups
Age, Continuous	66 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	22 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	37 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 6 weeks.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan, MRI, X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Arm I (Sorafenib Tosylate) n=15 Participants Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. sorafenib tosylate: Given PO laboratory biomarker analysis: Correlative studies	Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) n=37 Participants Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15. sorafenib tosylate: Given PO gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Objective Response (OR = CR or PR) as Determined by the RECIST Criteria	0 participants	1 participants

SECONDARY outcome

Timeframe: From first day of treatment to time of death due to any cause, assessed up to 6 months

Estimated using the product-limit method of Kaplan and Meier by arm.

Outcome measures

Measure	Arm I (Sorafenib Tosylate) n=15 Participants Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. sorafenib tosylate: Given PO laboratory biomarker analysis: Correlative studies	Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) n=37 Participants Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15. sorafenib tosylate: Given PO gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Overall Survival	4.3 Months Interval 3.3 to 8.3	6.5 Months Interval 5.5 to 8.0

SECONDARY outcome

Timeframe: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 3 months

Estimated using the product-limit method of Kaplan and Meier by arm. The probability of progression-free survival at 3 months and overall survival at 6 months, and their Greenwood's standard errors will be summarized by arm.

Outcome measures

Measure	Arm I (Sorafenib Tosylate) n=15 Participants Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. sorafenib tosylate: Given PO laboratory biomarker analysis: Correlative studies	Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) n=37 Participants Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15. sorafenib tosylate: Given PO gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Progression-free Survival	2.3 Months Interval 1.2 to 5.7	2.9 Months Interval 2.1 to 4.3

Adverse Events

Arm I (Sorafenib Tosylate)

Serious events: 8 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)

Serious events: 15 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Sorafenib Tosylate) n=15 participants at risk Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. sorafenib tosylate: Given PO laboratory biomarker analysis: Correlative studies	Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) n=37 participants at risk Patients receive 400 mg oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1, 8, and 15. sorafenib tosylate: Given PO gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Cardiac disorders Sinus tachycardia	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Cheilitis	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Intra-abdominal hemorrhage	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Obstruction gastric	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Death	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	13.3% 2/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders Gallbladder obstruction	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "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% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ischemia cerebrovascular	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	26.7% 4/15 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.8% 4/37 • Number of events 4 • Adverse Events occured over a 36 month period. "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 (Sorafenib Tosylate) n=15 participants at risk Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. sorafenib tosylate: Given PO laboratory biomarker analysis: Correlative studies	Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride) n=37 participants at risk Patients receive 400 mg oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1, 8, and 15. sorafenib tosylate: Given PO gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies
Nervous system disorders Neuralgia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.5% 5/37 • Number of events 6 • Adverse Events occured over a 36 month period. "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	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 11 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Speech disorder	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Blood disorder	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemoglobin decreased	26.7% 4/15 • Number of events 13 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.9% 17/37 • Number of events 49 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Ventricular flutter	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear disorder	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision blurred	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	66.7% 10/15 • Number of events 17 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	56.8% 21/37 • Number of events 45 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ascites	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	46.7% 7/15 • Number of events 9 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.8% 14/37 • Number of events 32 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	33.3% 5/15 • Number of events 18 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	43.2% 16/37 • Number of events 36 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ear, nose and throat examination abnormal	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.5% 5/37 • Number of events 6 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal mucositis	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.8% 4/37 • Number of events 6 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastro-intestinal fistula	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 5 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	53.3% 8/15 • Number of events 13 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.8% 14/37 • Number of events 23 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	6.7% 1/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	33.3% 5/15 • Number of events 8 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	21.6% 8/37 • Number of events 10 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.9% 7/37 • Number of events 7 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Death	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.9% 7/37 • Number of events 7 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	73.3% 11/15 • Number of events 11 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.6% 18/37 • Number of events 18 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.8% 4/37 • Number of events 8 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	66.7% 10/15 • Number of events 33 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	73.0% 27/37 • Number of events 64 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.8% 4/37 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu-like symptoms	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	6.7% 1/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pericardial pain	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Sudden death	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders Hepatic failure	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Hypersensitivity	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Wound infection	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	13.3% 2/15 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	51.4% 19/37 • Number of events 40 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	33.3% 5/15 • Number of events 14 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	59.5% 22/37 • Number of events 41 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	13.3% 2/15 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.6% 18/37 • Number of events 43 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	13.3% 2/15 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.2% 6/37 • Number of events 7 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	6.7% 1/15 • Number of events 6 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.3% 9/37 • Number of events 18 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	6.7% 1/15 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.9% 7/37 • Number of events 13 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	13.3% 2/15 • Number of events 6 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.9% 17/37 • Number of events 29 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	20.0% 3/15 • Number of events 10 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	56.8% 21/37 • Number of events 54 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Serum cholesterol increased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	20.0% 3/15 • Number of events 5 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.0% 10/37 • Number of events 15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	46.7% 7/15 • Number of events 17 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	56.8% 21/37 • Number of events 38 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood bicarbonate decreased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	13.3% 2/15 • Number of events 10 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.8% 14/37 • Number of events 29 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypernatremia	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	6.7% 1/15 • Number of events 6 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	21.6% 8/37 • Number of events 19 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	6.7% 1/15 • Number of events 5 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.3% 9/37 • Number of events 16 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	6.7% 1/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	13.3% 2/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	21.6% 8/37 • Number of events 16 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.2% 6/37 • Number of events 8 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.5% 5/37 • Number of events 7 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 7 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Iron increased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium increased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum phosphate decreased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum triglycerides increased	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "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	20.0% 3/15 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.8% 4/37 • Number of events 5 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint disorder	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "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	13.3% 2/15 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 3 • Adverse Events occured over a 36 month period. "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	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "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	13.3% 2/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/37 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.8% 4/37 • Number of events 6 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Mental status changes	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.9% 7/37 • Number of events 8 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Personality change	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Bladder hemorrhage	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hemorrhage urinary tract	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Proteinuria	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.1% 3/37 • Number of events 4 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Breast pain	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 4 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hiccough	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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 disorder	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Acne	13.3% 2/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 3 • Adverse Events occured over a 36 month period. "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	6.7% 1/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.0% 10/37 • Number of events 31 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 3 • Adverse Events occured over a 36 month period. "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	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	13.3% 2/15 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.5% 5/37 • Number of events 9 • Adverse Events occured over a 36 month period. "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	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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 desquamating	20.0% 3/15 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.3% 9/37 • Number of events 10 • Adverse Events occured over a 36 month period. "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 disorder	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Sweating	13.3% 2/15 • Number of events 4 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 3 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.4% 2/37 • Number of events 2 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Phlebitis	0.00% 0/15 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Phlebitis superficial	6.7% 1/15 • Number of events 1 • Adverse Events occured over a 36 month period. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.7% 1/37 • Number of events 1 • Adverse Events occured over a 36 month period. "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