Trial Outcomes & Findings for Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer (NCT NCT03023722)
NCT ID: NCT03023722
Last Updated: 2021-10-28
Results Overview
Primary efficacy will be assessed based on radiological tumor evaluation by contrast-enhanced computed tomography (CT) or contrast-enhanced magnetic resonance imaging (MRI) of chest/abdomen/pelvis. Contrast enhanced RECIST 1.1 scan will be done at Prescreening. Said pre-screen scan will be the baseline measure. RECIST 1.1 Scans will be done every 6 weeks for the first 6 months after the start of treatment, or more frequently if clinically indicated, every 9 weeks until the end of year 2 and every 12 weeks thereafter until disease progression or end of study, whichever comes first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From start of treatment until disease progression or death (up to 3 years).
Results posted on
2021-10-28
Participant Flow
Participant milestones
| Measure |
All Subjects
Patients with advanced metastatic pancreatic cancer who have measurable disease
anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Subjects
Patients with advanced metastatic pancreatic cancer who have measurable disease
anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
|
|---|---|
|
Overall Study
No follow-up assessment
|
4
|
Baseline Characteristics
Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
All Subjects
n=18 Participants
Patients with advanced metastatic pancreatic cancer who have measurable disease
anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
|
|---|---|
|
Age, Customized
50-59 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until disease progression or death (up to 3 years).Population: Of the 18 subjects originally enrolled, the analysis population includes the 14 subjects who completed the study. The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
Primary efficacy will be assessed based on radiological tumor evaluation by contrast-enhanced computed tomography (CT) or contrast-enhanced magnetic resonance imaging (MRI) of chest/abdomen/pelvis. Contrast enhanced RECIST 1.1 scan will be done at Prescreening. Said pre-screen scan will be the baseline measure. RECIST 1.1 Scans will be done every 6 weeks for the first 6 months after the start of treatment, or more frequently if clinically indicated, every 9 weeks until the end of year 2 and every 12 weeks thereafter until disease progression or end of study, whichever comes first.
Outcome measures
| Measure |
All Subjects
n=14 Participants
Patients with advanced metastatic pancreatic cancer who have measurable disease
anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
|
|---|---|
|
Response Rate as Measured Per RECIST 1.1 Criteria
progressive disease
|
12 Participants
|
|
Response Rate as Measured Per RECIST 1.1 Criteria
stable disease
|
2 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until disease progression or death (up to 3 years).Population: Of the 18 subjects originally enrolled, the analysis population includes the 14 subjects who completed the study. The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
Time to Progression (TTP) defined as time from study treatment to RECIST progression, or death (others going off study will be censored).
Outcome measures
| Measure |
All Subjects
n=14 Participants
Patients with advanced metastatic pancreatic cancer who have measurable disease
anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
|
|---|---|
|
Time to Progression
|
63.5 days
Interval 22.0 to 148.0
|
SECONDARY outcome
Timeframe: From start of treatment until disease progression or death (up to 3 years).Population: Detailed results are included under adverse events. The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
Toxicity of Anetumab ravtansine assessed with National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. See adverse events for details. Participants who experienced any adverse events are included here.
Outcome measures
| Measure |
All Subjects
n=18 Participants
Patients with advanced metastatic pancreatic cancer who have measurable disease
anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
|
|---|---|
|
Drug Toxicity
Serious adverse events · Yes
|
11 Participants
|
|
Drug Toxicity
Serious adverse events · No
|
7 Participants
|
|
Drug Toxicity
Other adverse events · Yes
|
18 Participants
|
|
Drug Toxicity
Other adverse events · No
|
0 Participants
|
Adverse Events
All Subjects
Serious events: 11 serious events
Other events: 18 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
All Subjects
n=18 participants at risk
Patients with advanced metastatic pancreatic cancer who have measurable disease
anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
|
|---|---|
|
General disorders
General Disorders and administration-other specify Failure to Thrive
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
General Disorders and administration-other specify Death NOS
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Infections and infestations
Infections and Infestations-Other, specify-Rhinovirus
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Fever
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Cognitive Disturbance
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Stroke
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Obstruction Gastric
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Ascites
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Skin and subcutaneous tissue disorders
Palmar Plantar Erythrodysesthes
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders-other
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Infections and infestations
Infections and Infestations-other
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure (Pleural metastatic PD)
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
Other adverse events
| Measure |
All Subjects
n=18 participants at risk
Patients with advanced metastatic pancreatic cancer who have measurable disease
anetumab ravtansine: Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle
|
|---|---|
|
Renal and urinary disorders
Hematuria
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
3/18 • Number of events 8 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Eye disorders
Cataract
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Chills
|
16.7%
3/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
12/18 • Number of events 19 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Cardiac disorders
Activated partial thromboplastin time prolonged
|
16.7%
3/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
3/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
6/18 • Number of events 7 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
8/18 • Number of events 12 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
61.1%
11/18 • Number of events 14 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Psychiatric disorders
Anxiety
|
27.8%
5/18 • Number of events 6 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Ascites
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
3/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Cardiac disorders
Atrial flutter
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Skin and subcutaneous tissue disorders
Basal Cell Carcinoma of Skin
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Renal and urinary disorders
Bladder Cancer
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Blood bilirubin increased
|
16.7%
3/18 • Number of events 6 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Eye disorders
Blurred vision
|
16.7%
3/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Cardiac troponin I increased
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Cholesterol high
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Constipation
|
61.1%
11/18 • Number of events 19 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Creatinine increased
|
5.6%
1/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Blood and lymphatic system disorders
Decreased Platelet Count
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
27.8%
5/18 • Number of events 8 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Psychiatric disorders
Depression
|
22.2%
4/18 • Number of events 5 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Diabetes
|
16.7%
3/18 • Number of events 3 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
10/18 • Number of events 16 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Dizziness
|
16.7%
3/18 • Number of events 3 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Eye disorders
Dry eye
|
38.9%
7/18 • Number of events 7 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
3/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Edema limbs
|
27.8%
5/18 • Number of events 7 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
11.1%
2/18 • Number of events 3 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Fatigue
|
77.8%
14/18 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Fever
|
11.1%
2/18 • Number of events 3 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
3/18 • Number of events 3 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
GGT increased
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Eye disorders
Glaucoma
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
GOUT
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Hypercholesterolemia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Vascular disorders
Hypertension
|
38.9%
7/18 • Number of events 17 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Blood and lymphatic system disorders
Hypertriglyceridemia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.1%
2/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
3/18 • Number of events 6 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
3/18 • Number of events 6 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
4/18 • Number of events 5 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
2/18 • Number of events 3 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Increased LDH
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Inguinal hernia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
INR increased
|
22.2%
4/18 • Number of events 5 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Psychiatric disorders
Insomnia
|
50.0%
9/18 • Number of events 12 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Investigations - Other, specify
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Investigations- other, specify
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Irritability
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Lipase
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Lymphocyte count decreased
|
27.8%
5/18 • Number of events 9 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Malabsorption
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis oral
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
9/18 • Number of events 18 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Neuropathy
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Occasional Epigastric Pain
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Cardiac disorders
Sick sinus syndrome
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Vascular disorders
Orthostatic Hypotension
|
5.6%
1/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Paresthesia
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
44.4%
8/18 • Number of events 12 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Platelet count decreased
|
22.2%
4/18 • Number of events 7 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Number of events 3 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Renal and urinary disorders
Proteinuria
|
27.8%
5/18 • Number of events 8 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Number of events 2 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
11.1%
2/18 • Number of events 3 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
Serum amylase increased
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Sinus tachycardia
|
11.1%
2/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
2/18 • Number of events 4 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
General disorders
Upper respiratory infection
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Infections and infestations
URI/ Sinus Symptoms
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Renal and urinary disorders
Urinary frequency
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
9/18 • Number of events 13 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Eye disorders
Watering eyes
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Gastrointestinal disorders
Weight loss
|
22.2%
4/18 • Number of events 5 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
|
Investigations
White blood cell decreased
|
5.6%
1/18 • Number of events 1 • Three years.
The original intention was to follow subjects for up to 3 years. However, all subjects died before the three year mark, so the study was concluded on Dec. 11.2019, after 2 years and 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place