Trial Outcomes & Findings for Study of Gene Modified Immune Cells in Patients With Advanced Melanoma (NCT NCT00910650)
NCT ID: NCT00910650
Last Updated: 2021-12-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
every 90 days for up to 3 years
Results posted on
2021-12-06
Participant Flow
Dates of recruitment period: 10/13/2009 to 04/04/2013 (suspended); 10/16/2013 to 02/07/2018 (closed for accrual). Location: University of California at Los Angeles medical Clinic.
Participant milestones
| Measure |
F5 T-cell Receptor (TCR) Transgenic Cells
F5 TCR transgenic cell adoptive transfer therapy
F5 TCR transgenic cells and Melanoma antigen recognized by T-cells (MART-1) peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose Interleukin-2 (IL-2) 500,000 IU/m2 s.c. twice daily for 14 days.
non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
F5 T-cell Receptor (TCR) Transgenic Cells
F5 TCR transgenic cell adoptive transfer therapy
F5 TCR transgenic cells and Melanoma antigen recognized by T-cells (MART-1) peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose Interleukin-2 (IL-2) 500,000 IU/m2 s.c. twice daily for 14 days.
non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Study of Gene Modified Immune Cells in Patients With Advanced Melanoma
Baseline characteristics by cohort
| Measure |
F5 TCR Transgenic Cells
n=14 Participants
F5 TCR transgenic cell adoptive transfer therapy
F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.
non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 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
|
13 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
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 90 days for up to 3 yearsPopulation: Maximum time in study: 3 years from 1st study drug administration.
Outcome measures
| Measure |
F5 TCR Transgenic Cells
n=14 Participants
F5 TCR transgenic cell adoptive transfer therapy
F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.
non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days
|
|---|---|
|
Response Rate: The Number of Participants Who Completed the Maximum Time Allowed on Study Without Being Affected by Tumor Recurrence or Progression.
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline from treatment for the life of the participant > 7 yearsOverall survival is measured until the patient passes away
Outcome measures
| Measure |
F5 TCR Transgenic Cells
n=14 Participants
F5 TCR transgenic cell adoptive transfer therapy
F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.
non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days
|
|---|---|
|
Overall Survival (OS)
Deceased
|
14 Participants
|
|
Overall Survival (OS)
Alive
|
0 Participants
|
Adverse Events
F5 TCR Transgenic Cells
Serious events: 5 serious events
Other events: 14 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
F5 TCR Transgenic Cells
n=14 participants at risk
F5 TCR transgenic cell adoptive transfer therapy
F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.
non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days
|
|---|---|
|
Vascular disorders
Anemia
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Deep Vein Thrombosis left subclavian
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Hypotension
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Pancytopenia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Rapid Drop in Hemoglobin level
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Renal and urinary disorders
Renal Insufficiency
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Seizures
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
Other adverse events
| Measure |
F5 TCR Transgenic Cells
n=14 participants at risk
F5 TCR transgenic cell adoptive transfer therapy
F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells: After chemotherapy, patients receive up to 1 x 10(9) MART-1 F5 TCR transgenic T cells infused i.v., 1 x 10(7) MART-1 peptide pulsed dendritic cells intradermally, and low dose IL-2 500,000 IU/m2 s.c. twice daily for 14 days.
non-myeloablative conditioning chemotherapy: Patients receive non-myeloablative conditioning chemotherapy with Cyclophosphamide 60 mg/kg/day x 2 days and Fludarabine 25 mg/m2/day i.v. over 30 minutes for 4 days
|
|---|---|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Abdomen distention
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Abdominal fullness
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Renal and urinary disorders
Abnormal Urinalysis
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Acidemia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Agitation
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Alkaline Phosphate Level elevated
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Psychiatric disorders
Altered level of consciousness
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Anasarca
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
absolute neutrophil count
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Anemia
|
78.6%
11/14 • Number of events 11 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Anorexia
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspartate Aminotransferase increased
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Atrial fibrilation
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Bardycardia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Bibasilar atelectasis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Bibasilar opacities
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral basilar crackles
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Basilar Rales
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Skin and subcutaneous tissue disorders
Blister (Skin)
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Blurry Vision
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Renal and urinary disorders
Brown Urine
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Capillary leak syndrome
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Chills
|
50.0%
7/14 • Number of events 7 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Cold feet
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Cold right hand finger tips
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Confusion
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Conjunctiva erythema
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Conjunctival hemorrhage
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Conjunctivitis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
7/14 • Number of events 7 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Coughs
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Creatinine elevated
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Dark purple feet
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Decreased breath sounds
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Deep Vein Thrombosis, Left Arm
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Dermatitis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Desaturation
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Diabetes
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Diaphoresis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Diarrhea
|
78.6%
11/14 • Number of events 11 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Diffuse tenderness to deep palpation
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Distal feet pain
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Distress
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Drowsy
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Ecchymosis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Edema (extremities)
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Edema: head and neck, periorbital
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Edema-limbs lower
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Edema-limbs upper
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Electrocytes Imbalance
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Elevated alanine aminotransferase
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Elevated aspartate transaminase
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Elevated blood pressure
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Enterococcus faecium
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Erythematous Joint, Left Shoulder
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Erythematous Nodule
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Facial Edema
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Fatigue
|
35.7%
5/14 • Number of events 5 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Febrile
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Fever
|
78.6%
11/14 • Number of events 11 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Fingertip Numbness
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Fluid overload
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Flushing arms/neck
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Gastric extension
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Gastroenteritis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Generalized Skin Erythema
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hematomas
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Renal and urinary disorders
Hematuria
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Hemiparesis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hemorrhoidal Pain
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hemorrhoids
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Hyperbilirubinemia
|
50.0%
7/14 • Number of events 7 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Hyperglycemia
|
50.0%
7/14 • Number of events 7 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Hypermagnesemia
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hypernatremia
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hyphosphatemia
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Skin and subcutaneous tissue disorders
Hypoalbuminemia
|
57.1%
8/14 • Number of events 8 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hypocalcemia
|
57.1%
8/14 • Number of events 8 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hypokalemia
|
64.3%
9/14 • Number of events 9 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hypomagnesemia
|
35.7%
5/14 • Number of events 5 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hyponatremia
|
71.4%
10/14 • Number of events 10 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Hypotension
|
35.7%
5/14 • Number of events 5 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Infected peripherally inserted central catheter (PICC) Site
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
International Normalized Ratio Creased
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Vascular disorders
Internal Bleeding
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Irregular heart rhythm/rate
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Ischemia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Labored breathing
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Left Ankle Edema
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Left arm pain
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
35.7%
5/14 • Number of events 5 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Low aspartate aminotransferase
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Low auto platelet count
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Lymphedema Lower Extremity
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Lymphocyte count decreased
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Lymphopenia
|
50.0%
7/14 • Number of events 7 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Macular rash
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Mixed bilirubinemia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Wall thickening of the cecum & ascending
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Monocyte decrease
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Mood alteration: Anxiety
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Mottled lower extremity
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Nausea
|
64.3%
9/14 • Number of events 9 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Neutropenia
|
71.4%
10/14 • Number of events 10 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Neutrophil Count decreased
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Neutrophil Count increased
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
No palpable dorsalis pedis pulses
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Numbing of bilateral feet
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Numbness/tingling in bilateral feet
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Oral candidiasis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Pain - Headache
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other, Peripherally Inserted Central Catheter (PICC) line site
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Pain- Abdominal
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Pain at sacrum
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Palpitation
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Pancytopenia
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Psychiatric disorders
Paranoia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Peripheral digital ischemia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Positive Blood Cultures
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Positive for Gallops
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Preicardial effusion
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Pressor-related ischemia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Renal and urinary disorders
Prostatitis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Proteinuria
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Pregnancy, puerperium and perinatal conditions
Pruritis
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary crackles
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Pulseless electrical activity
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Pulseless legs
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Rales and Crackles, Bilat w Bases
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Rash
|
78.6%
11/14 • Number of events 11 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Rash on Trunk
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Rash, Back, Abdomen
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Pregnancy, puerperium and perinatal conditions
Rash, Facial
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Rectal Abscess
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Endocrine disorders
Renal Failure, acute
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
21.4%
3/14 • Number of events 3 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Right lower lobe patchy opacification
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Rigors
|
71.4%
10/14 • Number of events 10 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Ringing in the ears
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Scrotal Swelling
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Seizure
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breathe
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Skin Desquamation
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Skin Erythema, Back and Torso
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Sloughing of skin in bilateral buttocks
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Sputum
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Stomach Gas
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Subconjunctival hemorrhage in both eyes
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Subcutaneous edema
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Subsegmental atelectasis
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Sweat
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Tachypenia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Tachypneic
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Upper gastrointestinal bleed
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Upset Stomach
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
78.6%
11/14 • Number of events 11 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Uveitis
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Visual hallucinations
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Musculoskeletal and connective tissue disorders
Vitiligo
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
2/14 • Number of events 2 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
White Blood Cell decreased
|
7.1%
1/14 • Number of events 1 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Cardiac disorders
Tachypenic
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
|
Nervous system disorders
Insomnia
|
28.6%
4/14 • Number of events 4 • 3 months and 1 week
Adverse Events and Serious Adverse Events monitored for the treatment period, 3 months and 1 week. All Cause mortality accessed for balance of participants life, up to seven years.
|
Additional Information
Ignacio Baselga
University of California at Los Angeles, Jonsson Comprehensive Cancer Center
Phone: 310 206-2090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place