Trial Outcomes & Findings for A Study of Ramucirumab (LY3009806) in Participants With Advanced Liver Cancer (NCT NCT02069041)
NCT ID: NCT02069041
Last Updated: 2018-11-21
Results Overview
A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Baseline through study completion (Up To 8 Months)
Results posted on
2018-11-21
Participant Flow
Participants completed the study if they completed 3 cycles or discontinued due to a DLT during the DLT assessment period.
Participant milestones
| Measure |
Ramucirumab + FOLFOX4
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
Received at Least One Dose of Study Drug
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All participants who received at least one dose of study drug and had baseline initial pathological diagnosis data.
Baseline characteristics by cohort
| Measure |
Ramucirumab + FOLFOX4
n=8 Participants
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
Age, Continuous
|
55.56 years
STANDARD_DEVIATION 11.06 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Taiwan
|
8 Participants
n=8 Participants
|
|
Basis of Initial Pathological Diagnosis
Histopathological
|
3 Participants
n=6 Participants • All participants who received at least one dose of study drug and had baseline initial pathological diagnosis data.
|
|
Basis of Initial Pathological Diagnosis
Cytological
|
1 Participants
n=6 Participants • All participants who received at least one dose of study drug and had baseline initial pathological diagnosis data.
|
|
Basis of Initial Pathological Diagnosis
Biochemical Assay and Imaging
|
2 Participants
n=6 Participants • All participants who received at least one dose of study drug and had baseline initial pathological diagnosis data.
|
|
Disease Stage
Stage I
|
0 Participants
n=6 Participants • All participants who received at least one dose of study drug and had baseline disease stage data.
|
|
Disease Stage
Stage II
|
1 Participants
n=6 Participants • All participants who received at least one dose of study drug and had baseline disease stage data.
|
|
Disease Stage
Stage III
|
4 Participants
n=6 Participants • All participants who received at least one dose of study drug and had baseline disease stage data.
|
|
Disease Stage
Stage IV
|
1 Participants
n=6 Participants • All participants who received at least one dose of study drug and had baseline disease stage data.
|
|
Disease Stage
Unknown
|
0 Participants
n=6 Participants • All participants who received at least one dose of study drug and had baseline disease stage data.
|
|
Duration of Disease (months)
|
0.345 months
n=6 Participants • All participants who received at least one dose of study drug and had baseline duration of disease data.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
4 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
4 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
0 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
>2
|
0 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
0 Participants
n=8 Participants
|
|
Barcelona Clinic Liver Cancer (BCLC) Classification
Stage A
|
0 Participants
n=8 Participants
|
|
Barcelona Clinic Liver Cancer (BCLC) Classification
Stage B
|
1 Participants
n=8 Participants
|
|
Barcelona Clinic Liver Cancer (BCLC) Classification
Stage C
|
7 Participants
n=8 Participants
|
|
Barcelona Clinic Liver Cancer (BCLC) Classification
Stage D
|
0 Participants
n=8 Participants
|
|
Barcelona Clinic Liver Cancer (BCLC) Classification
Missing
|
0 Participants
n=8 Participants
|
|
Viral hepatitis B
Test Positive
|
8 Participants
n=8 Participants
|
|
Viral hepatitis B
Test Negative
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (Up To 8 Months)Population: All participants who received at least one dose of study drug.
A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Ramucirumab + FOLFOX4
n=8 Participants
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
4 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 3: 0,1.0,1.5,2.0,3.0,5.0,24.0,48.0,168.0,336.0 hoursPopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Maximum Concentration (Cmax)
Outcome measures
| Measure |
Ramucirumab + FOLFOX4
n=8 Participants
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab
Cycle 1
|
155 ug/mL(microgram / milliliter)
Geometric Coefficient of Variation 25
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab
Cycle 3
|
190 ug/mL(microgram / milliliter)
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 3: 0,1.0,1.5,2.0,3.0,5.0,24.0,48.0,168.0,336.0 hoursPopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Area under the concentration-time curve.
Outcome measures
| Measure |
Ramucirumab + FOLFOX4
n=8 Participants
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
PK:Area Under the Concentration-Time Curve (AUC[0-∞]) of Ramucirumab
Cycle 1
|
940 microgram*day / milliliter)(ug*day/mL)
Geometric Coefficient of Variation 24
|
|
PK:Area Under the Concentration-Time Curve (AUC[0-∞]) of Ramucirumab
Cycle 3
|
1190 microgram*day / milliliter)(ug*day/mL)
Geometric Coefficient of Variation 25
|
SECONDARY outcome
Timeframe: Baseline through 6.1 MonthsPopulation: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Ramucirumab + FOLFOX4
n=8 Participants
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
Number of Participants With Anti-Ramucirumab Antibodies
|
0 Participants
|
SECONDARY outcome
Timeframe: Response to Disease Progression or Death (Up To 7 Months)Population: All participants who received at least one dose of study drug.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version\[v\] 1.1) criteria.CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease(PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Percentage of participants with CR or PR= (number of participants whose best overall response was CR or PR)/(number of participants treated)\*100.
Outcome measures
| Measure |
Ramucirumab + FOLFOX4
n=8 Participants
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
|
25 percentage of Participants
|
Adverse Events
Ramucirumab + FOLFOX4
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab + FOLFOX4
n=8 participants at risk
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
37.5%
3/8 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis bacterial
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Ramucirumab + FOLFOX4
n=8 participants at risk
8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:
FOLFOX4 every 2 weeks:
85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2
Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
3/8 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
75.0%
6/8 • Number of events 10
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
37.5%
3/8 • Number of events 6
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
62.5%
5/8 • Number of events 9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 7
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
37.5%
3/8 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 5
All participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 7
All participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
37.5%
3/8 • Number of events 4
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 8
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Periodontitis
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound complication
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 6
All participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
25.0%
2/8 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
62.5%
5/8 • Number of events 7
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
50.0%
4/8 • Number of events 12
All participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
37.5%
3/8 • Number of events 9
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
62.5%
5/8 • Number of events 9
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
4/8 • Number of events 10
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
2/8 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
12.5%
1/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
37.5%
3/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60