Trial Outcomes & Findings for Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery ("Personalized Medicine") (NCT NCT01726582)
NCT ID: NCT01726582
Last Updated: 2023-08-14
Results Overview
This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
229 participants
Primary outcome timeframe
At time of surgery (approximately 10 to 20 weeks after screening)
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
Milestones Related to Standard Therapy
The milestones described below represent the treatment progression patients follow for treatment of this disease. The milestone represents changes in therapy based on medical condition and are not intended to represent discrete events in the investigation. Study are not parsed for analysis among the treatment milestones.
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
|---|---|
|
Overall Study
STARTED
|
229
|
|
Overall Study
Treated
|
130
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
184
|
Reasons for withdrawal
| Measure |
Milestones Related to Standard Therapy
The milestones described below represent the treatment progression patients follow for treatment of this disease. The milestone represents changes in therapy based on medical condition and are not intended to represent discrete events in the investigation. Study are not parsed for analysis among the treatment milestones.
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
|---|---|
|
Overall Study
Physician Decision
|
99
|
|
Overall Study
Death
|
85
|
Baseline Characteristics
Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery ("Personalized Medicine")
Baseline characteristics by cohort
| Measure |
Milestones Related to Therapy
n=130 Participants
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
72 Participants
n=5 Participants
|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
130 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of surgery (approximately 10 to 20 weeks after screening)This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.
Outcome measures
| Measure |
Milestones Related to Usual Therapy
n=130 Participants
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
Milestones Related to Therapy (Non-Resected)
This population includes participants for whom surgical resection was contraindicated and did not occur.
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
|
|---|---|---|
|
Number of Subjects Completing Therapy Including Surgical Resection.
|
107 Participants
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.
This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.
Outcome measures
| Measure |
Milestones Related to Usual Therapy
n=107 Participants
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
Milestones Related to Therapy (Non-Resected)
n=23 Participants
This population includes participants for whom surgical resection was contraindicated and did not occur.
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
|
|---|---|---|
|
Overall Survival in Months
|
45 Months
Interval 24.0 to 60.0
|
11 Months
Interval 8.0 to 20.0
|
SECONDARY outcome
Timeframe: 5 yearsThis measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.
Outcome measures
| Measure |
Milestones Related to Usual Therapy
n=130 Participants
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
Milestones Related to Therapy (Non-Resected)
This population includes participants for whom surgical resection was contraindicated and did not occur.
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
|
|---|---|---|
|
Progression-free Survival
|
36 Participants
|
—
|
SECONDARY outcome
Timeframe: Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.
Outcome measures
| Measure |
Milestones Related to Usual Therapy
n=130 Participants
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
Milestones Related to Therapy (Non-Resected)
This population includes participants for whom surgical resection was contraindicated and did not occur.
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
|
|---|---|---|
|
Use of Biomarkers to Determine Course of Treatment
|
92 Participants
|
—
|
SECONDARY outcome
Timeframe: At time of surgery (approximately 10 to 20 weeks after screening)Population: Pathology results were not reported for two subject.
The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response).
Outcome measures
| Measure |
Milestones Related to Usual Therapy
n=107 Participants
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
Milestones Related to Therapy (Non-Resected)
This population includes participants for whom surgical resection was contraindicated and did not occur.
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
|
|---|---|---|
|
Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.
Complete Response
|
2 Participants
|
—
|
|
Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.
Near Complete Response
|
17 Participants
|
—
|
|
Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.
Partial Response
|
44 Participants
|
—
|
|
Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.
Poor or No Response
|
42 Participants
|
—
|
|
Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.
Results Not Available
|
2 Participants
|
—
|
Adverse Events
Milestones Related to Therapy
Serious events: 50 serious events
Other events: 0 other events
Deaths: 85 deaths
Serious adverse events
| Measure |
Milestones Related to Therapy
n=130 participants at risk
Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.
Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.
Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.
Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.
Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.
Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
3/130 • Number of events 3 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Blood and lymphatic system disorders
Febrile neutorpenia
|
2.3%
3/130 • Number of events 3 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/130 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
2/130 • Number of events 2 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Cardiac disorders
Sinus bradycardia
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Ascites
|
1.5%
2/130 • Number of events 2 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Colitis
|
2.3%
3/130 • Number of events 3 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
4.6%
6/130 • Number of events 6 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
1.5%
2/130 • Number of events 2 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
3/130 • Number of events 3 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.1%
4/130 • Number of events 4 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
2/130 • Number of events 2 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
General disorders
Edema limbs
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
General disorders
Fever
|
2.3%
3/130 • Number of events 3 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
General disorders
Flu-like symptoms
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.3%
3/130 • Number of events 3 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Infections and infestations
Abdominal infection
|
2.3%
3/130 • Number of events 3 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Infections and infestations
Biliary tract infection
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Infections and infestations
Catheter related infection
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Infections and infestations
Lung infection
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Infections and infestations
Sepsis
|
9.2%
12/130 • Number of events 12 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Infections and infestations
Skin infection
|
2.3%
3/130 • Number of events 3 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Infections and infestations
Urinary tract infection
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Injury, poisoning and procedural complications
Fall
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Investigations
Hyperglycemia
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Investigations
Hyponatremia
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Investigations
Neutrophil count decreased
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Investigations
White blood cell count decreased
|
1.5%
2/130 • Number of events 2 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Nervous system disorders
Stroke
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Nervous system disorders
Syncope
|
1.5%
2/130 • Number of events 2 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Psychiatric disorders
Depression
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Psychiatric disorders
Suicidal attempt
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Psychiatric disorders
Suicidal ideation
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Vascular disorders
Hypertension
|
0.77%
1/130 • Number of events 1 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Vascular disorders
Hypotension
|
3.1%
4/130 • Number of events 4 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
|
Vascular disorders
Thromboembolic event
|
1.5%
2/130 • Number of events 2 • 5 years
The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Susan Tsai, MD
Froedtert and the Medical College of Wisconsin
Phone: 414-955-1412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place