Trial Outcomes & Findings for Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery (NCT NCT02178241)

NCT ID: NCT02178241

Last Updated: 2019-12-16

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: Up to 36 months
• Results posted on: 2019-12-16

Participant Flow

Twenty-six patients were enrolled, but 2 did not receive treatment due to medication compliance related to diabetes and another deemed ineligible after registration but prior to treatment start.

Participant milestones

Measure	Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery

Baseline characteristics by cohort

Measure	Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) n=24 Participants Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
Age, Continuous	73 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	22 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment.

Outcome measures

Measure	Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) n=24 Participants Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
Observed Overall Response Rate	50 percentage of participants Interval 31.0 to 69.0

SECONDARY outcome

Timeframe: From the start until progression, death, or the start of another treatment, assessed up to 12 months

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using 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.

Outcome measures

Measure	Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) n=24 Participants Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
Progression-free Survival	5.3 months Interval 4.5 to 6.7

SECONDARY outcome

Timeframe: From start of treatment until death from any cause ,up to 36 months

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

Outcome measures

Measure	Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) n=24 Participants Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
Overall Survival	11.9 months Interval 5.6 to 20.4

SECONDARY outcome

Timeframe: Up to 36 months

Toxicities that Occurred in 10% or More of Patients or At Least Once as a Grade 3+ Adverse Event (excluding those toxicities classified as "unrelated" or "unlikely related" to study drugs). Toxicities graded using CTCAEv4 criteria.

Outcome measures

Measure	Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) n=24 Participants Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
Incidence of Adverse Events. Grade 3 or 4 : Hypotension	1 participants
Incidence of Adverse Events. Grade 1 or 2 : Anemia	7 participants
Incidence of Adverse Events. Grade 1 or 2 : Febrile neutropenia	3 participants
Incidence of Adverse Events. Grade 1 or 2 : Thrombotic microangiopathy	1 participants
Incidence of Adverse Events. Grade 1 or 2 : Chest pain - cardiac	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Heart failure	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Colitis	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Constipation	10 participants
Incidence of Adverse Events. Grade 1 or 2 : Diarrhea	7 participants
Incidence of Adverse Events. Grade 1 or 2 : Dry Mouth	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Mucositis oral	2 participants
Incidence of Adverse Events. Grade 1 or 2 : Nausea	7 participants
Incidence of Adverse Events. Grade 1 or 2 : Vomiting	2 participants
Incidence of Adverse Events. Grade 1 or 2 : Edema	9 participants
Incidence of Adverse Events. Grade 1 or 2 : Fatigue	13 participants
Incidence of Adverse Events. Grade 1 or 2 : Fever	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Appendicitis perforated	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Lung infection	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Sepsis	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Upper respiratory infection	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Urinary Tract Infection	1 participants
Incidence of Adverse Events. Grade 1 or 2 : Electrocardiogram QT	2 participants
Incidence of Adverse Events. Grade 1 or 2 : Weight Loss	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Lymphocyte Count Decreased	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Neutrophil Count Decreased	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Platelet Count Decreased	7 participants
Incidence of Adverse Events. Grade 1 or 2 : White Blood Cell Decreased	7 participants
Incidence of Adverse Events. Grade 1 or 2 : INR increased	1 participants
Incidence of Adverse Events. Grade 1 or 2 : Alanine Aminotransferase Increased	9 participants
Incidence of Adverse Events. Grade 1 or 2 : Aspartate Aminotransferase Incr	11 participants
Incidence of Adverse Events. Grade 1 or 2 : Creatinine Increased	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Anorexia	9 participants
Incidence of Adverse Events. Grade 1 or 2 : Hyperglycemia	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Dehydration	3 participants
Incidence of Adverse Events. Grade 1 or 2 : Hypoalbuminemia	8 participants
Incidence of Adverse Events. Grade 1 or 2 : Hypocalcemia	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Hypokalemia	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Hypomagnesemia	3 participants
Incidence of Adverse Events. Grade 1 or 2 : Hyponatremia	7 participants
Incidence of Adverse Events. Grade 1 or 2 : Hypophosphatemia	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Generalized Muscle Weakness	5 participants
Incidence of Adverse Events. Grade 1 or 2 : Grip Weakness	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Pain in Extremity	3 participants
Incidence of Adverse Events. Grade 1 or 2 : Dizziness	5 participants
Incidence of Adverse Events. Grade 1 or 2 : Dysgeusia	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Paresthesia	4 participants
Incidence of Adverse Events. Grade 1 or 2 : Peripheral Sensory Neuropathy	5 participants
Incidence of Adverse Events. Grade 1 or 2 : Insomnia	3 participants
Incidence of Adverse Events. Grade 1 or 2 : Dyspnea	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Pneumonitis	0 participants
Incidence of Adverse Events. Grade 1 or 2 : Sore Throat	3 participants
Incidence of Adverse Events. Grade 1 or 2 : Alopecia	12 participants
Incidence of Adverse Events. Grade 1 or 2 : Hypotension	2 participants
Incidence of Adverse Events. Grade 1 or 2 : Thromboembolic event	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Anemia	8 participants
Incidence of Adverse Events. Grade 3 or 4 : Febrile neutropenia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Thrombotic microangiopathy	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Chest pain - cardiac	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Heart failure	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Colitis	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Constipation	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Diarrhea	2 participants
Incidence of Adverse Events. Grade 3 or 4 : Dry Mouth	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Mucositis oral	2 participants
Incidence of Adverse Events. Grade 3 or 4 : Nausea	3 participants
Incidence of Adverse Events. Grade 3 or 4 : Vomiting	2 participants
Incidence of Adverse Events. Grade 3 or 4 : Edema	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Fatigue	7 participants
Incidence of Adverse Events. Grade 3 or 4 : Fever	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Appendicitis perforated	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Lung infection	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Sepsis	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Upper respiratory infection	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Urinary Tract Infection	2 participants
Incidence of Adverse Events. Grade 3 or 4 : Electrocardiogram QT	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Weight Loss	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Lymphocyte Count Decreased	6 participants
Incidence of Adverse Events. Grade 3 or 4 : Neutrophil Count Decreased	15 participants
Incidence of Adverse Events. Grade 3 or 4 : Platelet Count Decreased	3 participants
Incidence of Adverse Events. Grade 3 or 4 : White Blood Cell Decreased	13 participants
Incidence of Adverse Events. Grade 3 or 4 : INR increased	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Alanine Aminotransferase Increased	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Aspartate Aminotransferase Incr	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Creatinine Increased	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Anorexia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Hyperglycemia	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Dehydration	2 participants
Incidence of Adverse Events. Grade 3 or 4 : Hypoalbuminemia	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Hypocalcemia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Hypokalemia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Hypomagnesemia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Hyponatremia	2 participants
Incidence of Adverse Events. Grade 3 or 4 : Hypophosphatemia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Generalized Muscle Weakness	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Grip Weakness	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Pain in Extremity	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Dizziness	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Dysgeusia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Paresthesia	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Peripheral Sensory Neuropathy	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Insomnia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Dyspnea	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Pneumonitis	1 participants
Incidence of Adverse Events. Grade 3 or 4 : Sore Throat	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Alopecia	0 participants
Incidence of Adverse Events. Grade 3 or 4 : Thromboembolic event	1 participants

Adverse Events

Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)

Serious events: 16 serious events

Other events: 24 other events

Deaths: 20 deaths

Serious adverse events

Measure	Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) n=24 participants at risk Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
Blood and lymphatic system disorders Anemia	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Febrile neutropenia	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Thrombotic Microangiopathy	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Chest pain - cardiac	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Heart failure	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Myocardial infarction	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Colitis	12.5% 3/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	8.3% 2/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Death NOS	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Appendicitis perforated	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations CELLULITIS	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sepsis	12.5% 3/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	12.5% 3/24 • Number of events 4 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	8.3% 2/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 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	16.7% 4/24 • Number of events 7 • Adverse events occurred over a period of 2 years and 10 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	12.5% 3/24 • Number of events 4 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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) Death	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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) Disease progression	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride) n=24 participants at risk Patients receive 1000mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 1.4mg/m\^2 eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Eribulin Mesylate: Given IV Gemcitabine Hydrochloride: Given IV
Blood and lymphatic system disorders Anemia	75.0% 18/24 • Number of events 113 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Febrile neutropenia	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Chest Pain	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Heart failure	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Hyperthyroidism	4.2% 1/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blurred vision	8.3% 2/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Cataract	4.2% 1/24 • Number of events 6 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye	8.3% 2/24 • Number of events 6 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Watering eyes	8.3% 2/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	20.8% 5/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Bloating	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	54.2% 13/24 • Number of events 42 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders DUODENITIS	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	45.8% 11/24 • Number of events 16 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	16.7% 4/24 • Number of events 16 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	12.5% 3/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	4.2% 1/24 • Number of events 12 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gum Bleeding	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Heartburn	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	4.2% 1/24 • Number of events 13 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	16.7% 4/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	45.8% 11/24 • Number of events 19 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal fistula	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Toothache	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	25.0% 6/24 • Number of events 8 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders hematochiza	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	45.8% 11/24 • Number of events 46 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	83.3% 20/24 • Number of events 117 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	33.3% 8/24 • Number of events 16 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Gait disturbance	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Leg Pain	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Malaise	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	29.2% 7/24 • Number of events 25 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Plantar fasciitis	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders vein irritation	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Athlete's foot	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pharyngitis	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	12.5% 3/24 • Number of events 6 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Toe infection	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	12.5% 3/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 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	41.7% 10/24 • Number of events 18 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations oral thrush	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	16.7% 4/24 • Number of events 12 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 8 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	54.2% 13/24 • Number of events 33 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	25.0% 6/24 • Number of events 16 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	50.0% 12/24 • Number of events 42 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	8.3% 2/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Cardiac troponin I increased	4.2% 1/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	41.7% 10/24 • Number of events 34 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Decreased ANC	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Decreased Creatinine Clearance	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Electrocardiogram QT corrected interval	12.5% 3/24 • Number of events 8 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	16.7% 4/24 • Number of events 21 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lactic Acidosis Increased	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	41.7% 10/24 • Number of events 67 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	75.0% 18/24 • Number of events 72 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	41.7% 10/24 • Number of events 49 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	16.7% 4/24 • Number of events 14 • Adverse events occurred over a period of 2 years and 10 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	75.0% 18/24 • Number of events 107 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	41.7% 10/24 • Number of events 30 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Decreased eGFR	4.2% 1/24 • Number of events 4 • Adverse events occurred over a period of 2 years and 10 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	12.5% 3/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	37.5% 9/24 • Number of events 35 • Adverse events occurred over a period of 2 years and 10 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	12.5% 3/24 • Number of events 6 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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	54.2% 13/24 • Number of events 65 • Adverse events occurred over a period of 2 years and 10 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	45.8% 11/24 • Number of events 31 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 4 • Adverse events occurred over a period of 2 years and 10 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	33.3% 8/24 • Number of events 9 • Adverse events occurred over a period of 2 years and 10 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	16.7% 4/24 • Number of events 15 • Adverse events occurred over a period of 2 years and 10 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	41.7% 10/24 • Number of events 20 • Adverse events occurred over a period of 2 years and 10 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	37.5% 9/24 • Number of events 27 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders elevated LDH	4.2% 1/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 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	12.5% 3/24 • Number of events 4 • Adverse events occurred over a period of 2 years and 10 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	25.0% 6/24 • Number of events 22 • Adverse events occurred over a period of 2 years and 10 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 Grip Weakness	4.2% 1/24 • Number of events 14 • Adverse events occurred over a period of 2 years and 10 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 spasms	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	20.8% 5/24 • Number of events 12 • Adverse events occurred over a period of 2 years and 10 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 grip weakness	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Amnesia	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	20.8% 5/24 • Number of events 25 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysgeusia	16.7% 4/24 • Number of events 10 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Lethargy	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	25.0% 6/24 • Number of events 41 • Adverse events occurred over a period of 2 years and 10 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	12.5% 3/24 • Number of events 10 • Adverse events occurred over a period of 2 years and 10 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	33.3% 8/24 • Number of events 28 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	8.3% 2/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	8.3% 2/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	12.5% 3/24 • Number of events 8 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	20.8% 5/24 • Number of events 10 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Suicidal ideation	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	29.2% 7/24 • Number of events 13 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	20.8% 5/24 • Number of events 11 • Adverse events occurred over a period of 2 years and 10 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	20.8% 5/24 • Number of events 15 • Adverse events occurred over a period of 2 years and 10 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 Hemoptysis	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	4.2% 1/24 • Number of events 10 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	16.7% 4/24 • Number of events 5 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 3 • Adverse events occurred over a period of 2 years and 10 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 Shortness of Breath	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	16.7% 4/24 • Number of events 7 • Adverse events occurred over a period of 2 years and 10 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	54.2% 13/24 • Number of events 76 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 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 RT Lower Leg	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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- RT Lower Leg	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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 IV site discomfort	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	8.3% 2/24 • Number of events 6 • Adverse events occurred over a period of 2 years and 10 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 Purple Macular Lesion Back of Neck	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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 Purple Macular Lesion Base of Neck	4.2% 1/24 • Number of events 4 • Adverse events occurred over a period of 2 years and 10 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 Purple Macular Leson Base of Neck	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 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 increased nail growth	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Surgical and medical procedures Mediport Placement	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Surgical and medical procedures Right Cataract Surgery	4.2% 1/24 • Number of events 2 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	29.2% 7/24 • Number of events 27 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	12.5% 3/24 • Number of events 9 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Superficial thrombophlebitis	4.2% 1/24 • Number of events 1 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	4.2% 1/24 • Number of events 8 • Adverse events occurred over a period of 2 years and 10 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: pfrankel@coh.org

Results disclosure agreements

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

Restriction type: LTE60