Trial Outcomes & Findings for Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE) (NCT NCT03331250)
NCT ID: NCT03331250
Last Updated: 2025-12-23
Results Overview
The ORR is defined as the percentage of patients who achieved a partial response or complete response by RECIST 1.1. Tumor imaging studies were completed using either CT (Computed Tomography) or MRI (Magnetic resonance imaging). The modality chosen for any individual patient was the same from baseline until the end of their time on study. Per RECIST v 1.1, complete response (CR) is defined as the disappearance of all target lesions and the reduction in any pathological lymph nodes in short axis to less than 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions compared with baseline. Progressive disease (PD) is defined as a 20% increase (5+ mm absolute increase) compared with the smallest sum on study. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor PD.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
2 years
Results posted on
2025-12-23
Participant Flow
Participant milestones
| Measure |
Eribulin
* Eribulin administered twice per cycle intravenously
* Each cycle contains 21 days
* Dosing is per the FDA label for other cancers
Eribulin: It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Eribulin
* Eribulin administered twice per cycle intravenously
* Each cycle contains 21 days
* Dosing is per the FDA label for other cancers
Eribulin: It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Eribulin in Angiosarcoma and Epithelioid Hemangioendothelioma (EHE)
Baseline characteristics by cohort
| Measure |
Eribulin
n=13 Participants
* Eribulin administered twice per cycle intravenously
* Each cycle contains 21 days
* Dosing is per the FDA label for other cancers
Eribulin: It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
|
|---|---|
|
Age, Continuous
|
61.7 years
n=68 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: One patient out of the 13 who enrolled withdrew from the study before completing any cycles of study treatment.
The ORR is defined as the percentage of patients who achieved a partial response or complete response by RECIST 1.1. Tumor imaging studies were completed using either CT (Computed Tomography) or MRI (Magnetic resonance imaging). The modality chosen for any individual patient was the same from baseline until the end of their time on study. Per RECIST v 1.1, complete response (CR) is defined as the disappearance of all target lesions and the reduction in any pathological lymph nodes in short axis to less than 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions compared with baseline. Progressive disease (PD) is defined as a 20% increase (5+ mm absolute increase) compared with the smallest sum on study. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor PD.
Outcome measures
| Measure |
Eribulin
n=12 Participants
* Eribulin administered twice per cycle intravenously
* Each cycle contains 21 days
* Dosing is per the FDA label for other cancers
Eribulin: It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
|
|---|---|
|
Objective Response Rate (ORR)
|
4 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksObjective Response plus Stable Disease Rate at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsSummary of the treatment related adverse events experienced by study participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
Outcome measures
Outcome data not reported
Adverse Events
Eribulin
Serious events: 3 serious events
Other events: 13 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Eribulin
n=13 participants at risk
* Eribulin administered twice per cycle intravenously
* Each cycle contains 21 days
* Dosing is per the FDA label for other cancers
Eribulin: It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Infections and infestations
Periorbital infection
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Typhlitis
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
Other adverse events
| Measure |
Eribulin
n=13 participants at risk
* Eribulin administered twice per cycle intravenously
* Each cycle contains 21 days
* Dosing is per the FDA label for other cancers
Eribulin: It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
|
|---|---|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.1%
3/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
General disorders
Fatigue
|
46.2%
6/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Psychiatric disorders
Insomnia
|
30.8%
4/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Infections and infestations
Lung infection
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Investigations
Lymphocyte count decreased
|
23.1%
3/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
23.1%
3/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Investigations
Neutrophil count decreased
|
23.1%
3/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
General disorders
Pain
|
30.8%
4/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Infections and infestations
Periorbital infection
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
46.2%
6/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Infections and infestations
Skin infection
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Eye disorders
Watering eyes
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Investigations
Weight loss
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Investigations
White blood cell decreased
|
23.1%
3/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.8%
4/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Blood and lymphatic system disorders
Anemia
|
46.2%
6/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Investigations
Aspartate aminotransferase increased
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Bloating
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.4%
2/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Injury, poisoning and procedural complications
Burn
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
General disorders
Chills
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.5%
5/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • All AEs were collected from cycle 1 day 1 until either 28 days after the subject's last dose (an average 37 weeks), or resolution/stabilization of an AE if continuing beyond 28 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place