Trial Outcomes & Findings for Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors (NCT NCT00730483)
NCT ID: NCT00730483
Last Updated: 2017-08-25
Results Overview
Safety was assessed at each DEB-TACE procedure and at every follow-up thereafter according to National Cancer Institute Common Toxicity Criteria (CTCAE) v3.0. The study was prematurely terminated due to high incidence of biloma and liver abscess. Safety data below is based off of 13 patients enrolled on protocol at 1 month post initial treatment.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
1 month after initial DEB-TACE treatment
Results posted on
2017-08-25
Participant Flow
13 patients were enrolled on this protocol at Johns Hopkins University. This study was terminated early due to high incidence of bilomas in patients receiving TACE treatment.
Participant milestones
| Measure |
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
1 Month After First DEB-TACE
|
13
|
|
Overall Study
6 Months After First DEB-TACE
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
n=13 Participants
Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after initial DEB-TACE treatmentSafety was assessed at each DEB-TACE procedure and at every follow-up thereafter according to National Cancer Institute Common Toxicity Criteria (CTCAE) v3.0. The study was prematurely terminated due to high incidence of biloma and liver abscess. Safety data below is based off of 13 patients enrolled on protocol at 1 month post initial treatment.
Outcome measures
| Measure |
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
n=13 Participants
Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
|
|---|---|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Hypoalbuminemia
|
5 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Anemia
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Lymphopenia
|
2 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Hypotension
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Edema
|
2 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Increased INR
|
2 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Fatigue
|
9 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Fever
|
4 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Night sweats
|
6 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Alopecia
|
3 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Dry skin
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Ascites
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Anorexia
|
5 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Biloma
|
6 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Constipation
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Diarrhea
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Nausea
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Taste alteration
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Hematoma
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Increased ALT
|
5 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Increased AST
|
5 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Increased AP
|
8 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Hyperbilirubinemia
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Liver abscess
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Hyperglycemia
|
5 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Hyponatremia
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Neuropathy
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Abdominal nonspecific pain
|
5 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Right upper quadrant pain
|
6 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Pain - other
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Dyspnea
|
1 number of adverse events
|
|
Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE
Dyspnea on exertion
|
1 number of adverse events
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 13 patients were analyzed for 1 month post-treatment; 10 patients for 6 months post-treatment; and 6 patients at the 12 month post-treatment time point.
Study was terminated and full outcome not assessed. The results below are based on 13 patients at 1 month post DEB-TACE, 10 patients at 6 months, and 6 patients at 12 months. RECIST: Complete Response (CR): Disappearance of all targeted lesions Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): At least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Cases that are not applicable for PD or PR. EASL: CR: Absence of any enhancement in target lesion PR: Greater than 50% decrease from baseline enhancement in target lesion PD: Greater than 25% increase in target lesion SD: All other cases
Outcome measures
| Measure |
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
n=13 Participants
Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
|
|---|---|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 1 month post-TACE · Complete Response (CR)
|
0 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 1 month post-TACE · Partial Response (PR)
|
0 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 1 month post-TACE · Stable Disease (SD)
|
13 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 1 month post-TACE · Progressive Disease
|
0 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 1 month post-TACE · Complete Response (CR)
|
0 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 1 month post-TACE · Partial Response (PR)
|
8 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 1 month post-TACE · Stable Disease (SD)
|
5 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 1 month post-TACE · Progressive Disease
|
0 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 6 months post-TACE · Complete Response (CR)
|
0 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 6 months post-TACE · Partial Response (PR)
|
1 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 6 months post-TACE · Stable Disease (SD)
|
8 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 6 months post-TACE · Progressive Disease
|
1 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 6 months post-TACE · Complete Response (CR)
|
1 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 6 months post-TACE · Partial Response (PR)
|
3 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 6 months post-TACE · Stable Disease (SD)
|
6 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 6 months post-TACE · Progressive Disease
|
0 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 12 months post-TACE · Complete Response (CR)
|
0 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 12 months post-TACE · Partial Response (PR)
|
1 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 12 months post-TACE · Stable Disease (SD)
|
4 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
RECIST 12 months post-TACE · Progressive Disease
|
1 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 12 months post-TACE · Complete Response (CR)
|
2 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 12 months post-TACE · Partial Response (PR)
|
1 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 12 months post-TACE · Stable Disease (SD)
|
3 Participants
|
|
Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria
EASL 12 months post-TACE · Progressive Disease
|
0 Participants
|
SECONDARY outcome
Timeframe: overall survivalSurvival outcomes not assessed due to premature termination of study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time to progression, 12 monthsBiochemical response not assessed due to premature termination of study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of study participation, average of 12 monthsSymptomatic response not assessed due to premature termination of study. Scoring system for assessing symptom severity in patients with neuroendocrine/carcinoid syndrome was as follows: 1. \- No symptoms - Patient completely asymptomatic 2. \- Mild symptoms - Patient with symptoms of diarrhea, flushing, or asthma up to 4 times weekly 3. \- Symptoms impact daily living - symptoms of diarrhea, flushing, or asthma up 5-7 weekly 4. \- Severe symptoms - multiple daily symptoms of diarrhea, flushing, or asthma; symptoms require significant reorganization of daily activities 5. \- Disabling symptoms - Patient disabled by multiple attacks and severe symptoms; unable to leave home or requires hospitalization
Outcome measures
Outcome data not reported
Adverse Events
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
n=13 participants at risk
Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
|
|---|---|
|
Gastrointestinal disorders
Liver biloma requiring drainage
|
30.8%
4/13 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Gastric varices
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Liver abscess
|
15.4%
2/13 • Number of events 2 • 12 months
|
|
Hepatobiliary disorders
Biliary stricture
|
7.7%
1/13 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE)
n=13 participants at risk
Patients were treated with DEB-TACE loaded with doxorubicin up to four procedures in 6 months as indicated, for a maximum of six procedures during the course of 2 years. Follow-up clinical examinations, laboratory assessments, and imaging took place 1 month after each DEB-TACE treatment and then every 2 to 3 months for a period of 2 years. Each DEB-TACE procedure used a maximum of 100mg doxorubicin loaded onto 100-300um LC Beads.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
69.2%
9/13 • Number of events 25 • 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.1%
3/13 • Number of events 3 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
23.1%
3/13 • Number of events 5 • 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
46.2%
6/13 • Number of events 8 • 12 months
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Bloating
|
15.4%
2/13 • Number of events 2 • 12 months
|
|
Cardiac disorders
Bradycardia
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
General disorders
Chills
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
General disorders
Pain - coccyx
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
46.2%
6/13 • Number of events 8 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Eye disorders
Decreased vision
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
3/13 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.4%
2/13 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Number of events 2 • 12 months
|
|
General disorders
Edema - bilateral extremities
|
23.1%
3/13 • Number of events 3 • 12 months
|
|
Investigations
Elevated ALT
|
76.9%
10/13 • Number of events 14 • 12 months
|
|
General disorders
Elevated alkaline phosphatase
|
84.6%
11/13 • Number of events 20 • 12 months
|
|
Investigations
Elevated AST
|
84.6%
11/13 • Number of events 15 • 12 months
|
|
Investigations
Elevated INR
|
38.5%
5/13 • Number of events 5 • 12 months
|
|
General disorders
Fatigue
|
100.0%
13/13 • Number of events 27 • 12 months
|
|
General disorders
Fever
|
46.2%
6/13 • Number of events 6 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
15.4%
2/13 • Number of events 2 • 12 months
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
General disorders
Pain - general
|
15.4%
2/13 • Number of events 2 • 12 months
|
|
General disorders
Edema - hands
|
7.7%
1/13 • Number of events 2 • 12 months
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Investigations
Hyperbilirubinemia
|
15.4%
2/13 • Number of events 4 • 12 months
|
|
Investigations
Hyperglycemia
|
69.2%
9/13 • Number of events 12 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
53.8%
7/13 • Number of events 9 • 12 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
2/13 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
General disorders
Hypothermia
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Insomnia
|
23.1%
3/13 • Number of events 3 • 12 months
|
|
Skin and subcutaneous tissue disorders
Itching
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Eye disorders
Left eye swelling
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytopenia
|
7.7%
1/13 • Number of events 2 • 12 months
|
|
Investigations
Lymphopenia
|
30.8%
4/13 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • Number of events 8 • 12 months
|
|
Nervous system disorders
Neuropathy
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
53.8%
7/13 • Number of events 12 • 12 months
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right flank pain
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Vascular disorders
Hematoma
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Investigations
Thrombocytopenia
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Number of events 5 • 12 months
|
|
Investigations
Weight loss
|
7.7%
1/13 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place