NCT02178241 · OUTCOME

Incidence of Adverse Events.

Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery · Source last updated 2019-12-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Up to 36 months

What was measured

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.

Groups in this outcome

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	24

Reported measurements

Grade 1 or 2 : Anemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	7	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Febrile neutropenia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	3	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Thrombotic microangiopathy

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Chest pain - cardiac

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Heart failure

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Colitis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Constipation

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	10	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Diarrhea

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	7	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Dry Mouth

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Mucositis oral

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Nausea

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	7	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Vomiting

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Edema

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	9	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Fatigue

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	13	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Fever

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Appendicitis perforated

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Lung infection

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Sepsis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Upper respiratory infection

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Urinary Tract Infection

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Electrocardiogram QT

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Weight Loss

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Lymphocyte Count Decreased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Neutrophil Count Decreased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Platelet Count Decreased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	7	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : White Blood Cell Decreased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	7	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : INR increased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Alanine Aminotransferase Increased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	9	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Aspartate Aminotransferase Incr

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	11	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Creatinine Increased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Anorexia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	9	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Hyperglycemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Dehydration

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	3	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Hypoalbuminemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	8	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Hypocalcemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Hypokalemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Hypomagnesemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	3	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Hyponatremia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	7	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Hypophosphatemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Generalized Muscle Weakness

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	5	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Grip Weakness

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Pain in Extremity

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	3	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Dizziness

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	5	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Dysgeusia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Paresthesia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	4	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Peripheral Sensory Neuropathy

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	5	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Insomnia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	3	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Dyspnea

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Pneumonitis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Sore Throat

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	3	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Alopecia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	12	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Hypotension

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 1 or 2 : Thromboembolic event

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Anemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	8	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Febrile neutropenia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Thrombotic microangiopathy

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Chest pain - cardiac

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Heart failure

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Colitis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Constipation

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Diarrhea

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Dry Mouth

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Mucositis oral

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Nausea

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	3	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Vomiting

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Edema

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Fatigue

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	7	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Fever

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Appendicitis perforated

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Lung infection

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Sepsis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Upper respiratory infection

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Urinary Tract Infection

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Electrocardiogram QT

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Weight Loss

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Lymphocyte Count Decreased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	6	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Neutrophil Count Decreased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	15	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Platelet Count Decreased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	3	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : White Blood Cell Decreased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	13	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : INR increased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Alanine Aminotransferase Increased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Aspartate Aminotransferase Incr

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Creatinine Increased

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Anorexia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Hyperglycemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Dehydration

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Hypoalbuminemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Hypocalcemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Hypokalemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Hypomagnesemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Hyponatremia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	2	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Hypophosphatemia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Generalized Muscle Weakness

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Grip Weakness

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Pain in Extremity

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Dizziness

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Dysgeusia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Paresthesia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Peripheral Sensory Neuropathy

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Insomnia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Dyspnea

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Pneumonitis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Sore Throat

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Alopecia

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	0	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Hypotension

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Grade 3 or 4 : Thromboembolic event

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
7
title
Grade 1 or 2 : Anemia
categories
measurements
group Id
OG000
value
3
title
Grade 1 or 2 : Febrile neutropenia
categories
measurements
group Id
OG000
value
1
title
Grade 1 or 2 : Thrombotic microangiopathy
categories
measurements
group Id
OG000
value
0
title
Grade 1 or 2 : Chest pain - cardiac
categories
measurements
group Id
OG000
value
0
title
Grade 1 or 2 : Heart failure
categories
measurements
group Id
OG000
value
0
title
Grade 1 or 2 : Colitis
categories
measurements
group Id
OG000
value
10
title
Grade 1 or 2 : Constipation
categories
measurements
group Id
OG000
value
7
title
Grade 1 or 2 : Diarrhea
categories
measurements
group Id
OG000
value
4
title
Grade 1 or 2 : Dry Mouth
categories
measurements
group Id
OG000
value
2
title
Grade 1 or 2 : Mucositis oral
categories
measurements
group Id
OG000
value
7
title
Grade 1 or 2 : Nausea
categories
measurements
group Id
OG000
value
2
title
Grade 1 or 2 : Vomiting

denoms

counts
group Id
OG000
value
24
units
Participants

description

groups

description
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
id
OG000
title
Treatment (Eribulin Mesylate and Gemcitabine Hydrochloride)

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to 36 months

title

Incidence of Adverse Events.

type

SECONDARY

unit Of Measure

participants

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Preserved source evidence · Not medical advice