Trial Outcomes & Findings for Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT01769209)

Last Updated: 2018-11-14

Results Overview

Response Rate (RR) was determined as the sum of complete response (CR) and partial response (PR). Due to overlap, "complete response rate without platelet recovery" (CRp) is not included in Response Rate (RR). The outcome is reported as the total number without dispersion. * CR = No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) \> 1,000/microliter; platelets \> 100,000/microliter; \< 5% blasts in bone marrow. * CRp = Meets all criteria for CR except platelet count. * PR = Meets all criteria for CR except bone marrow contains 5 to 25% leukemia cells.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Day 29

Results posted on

2018-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Bortezomib + Chemotherapy Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bortezomib + Chemotherapy n=18 Participants Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.2 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Outcome measures

Outcome measures
Measure	Bortezomib + Chemotherapy n=18 Participants Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Response Rate (RR)	11 Participants

SECONDARY outcome

Timeframe: Day 29

Complete response (CR) was determined the number of participants who achieved CR by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. CR is defined as: * CR = No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) \> 1,000/microliter; platelets \> 100,000/microliter; \< 5% blasts in bone marrow. * Not CR = All statuses and conditions if less than or not as defined.

Outcome measures

Outcome measures
Measure	Bortezomib + Chemotherapy n=18 Participants Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Complete Response (CR)	11 Participants

SECONDARY outcome

Timeframe: Day 29

Complete response without platelet recovery (CR) was determined as the number of participants who achieved CRp by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. The outcome reflects only those subjects that meet all complete response (CR) criteria except platelet count; participants that meet all criteria including platelet count are not included in this outcome. CR and CRp are defined below. * CR =.No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) \> 1,000/microliter; platelets \> 100,000/microliter; \< 5% blasts in bone marrow. * CRp = Meets all criteria for CR except platelet count.

Outcome measures

Outcome measures
Measure	Bortezomib + Chemotherapy n=18 Participants Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Complete Response Without Platelet Recovery (CRp)	1 Participants

SECONDARY outcome

Timeframe: 2 years

Progression-free survival (PFS) was assessed as survival without progression at 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression. Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease.

Outcome measures

Outcome measures
Measure	Bortezomib + Chemotherapy n=18 Participants Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Progression-free Survival (PFS)	3 Participants

SECONDARY outcome

Timeframe: 1 year

Failure-free survival (FFS) was assessed as survival without progression or the addition of another systemic therapy, at or within 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression. Progression is defined below. Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease.

Outcome measures

Outcome measures
Measure	Bortezomib + Chemotherapy n=18 Participants Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Failure-free Survival (FFS)	3 Participants

SECONDARY outcome

Timeframe: 2 years

Overall survival (OS) was assessed as participants remaining alive 2 years after induction therapy. The outcome is reported as the number of participants (without dispersion).

Outcome measures

Outcome measures
Measure	Bortezomib + Chemotherapy n=18 Participants Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Overall Survival (OS)	5 Participants

SECONDARY outcome

Timeframe: 45 days

Population: Events specifically defined per protocol as "Hematologic Toxicity" or"Non-hematologic Toxicity" are included under the specific Body System and as a Hematologic or Non-hematologic Toxicity.

Toxicity was assessed as related grade 3, 4, or 5 adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. The outcome is reported as the total numbers of events (without dispersion) by CTCAE Body System, and whether the event was a hematologic toxicity or non-hematologic toxicity.

Outcome measures

Outcome measures
Measure	Bortezomib + Chemotherapy n=18 Participants Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Related Adverse Events (Grade 3, 4, 5) Gastrointestinal Disorders	9 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Blood and Lymphatic System Disorders	109 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Hepatobiliary disorders	2 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Infections and Infestations	17 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Investigations	78 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Metabolism and Nutrition Disorders	49 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Nervous System Disorders	1 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Respiratory, Thoracic and Mediastinal Disorders	1 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Vascular Disorders	2 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Hematologic Toxicity	63 Treatment-related adverse events
Related Adverse Events (Grade 3, 4, 5) Non-hematologic Toxicity	52 Treatment-related adverse events

SECONDARY outcome

Timeframe: 2 years

Population: Assay development was unsuccessful, and the assessment and analysis were not conducted for any samples.

Circulating acute lymphoblastic leukemia (ALL) blast cells were to be evaluated for the presence of reactive oxygen species (ROS).

Outcome measures

Outcome data not reported

Adverse Events

Bortezomib + Chemotherapy

Serious events: 10 serious events

Other events: 18 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Bortezomib + Chemotherapy n=18 participants at risk Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Blood and lymphatic system disorders Neutropenic fever (febrile neutropenia)	5.6% 1/18 • Number of events 1 • 2 years
Blood and lymphatic system disorders Disseminated intravascular coagulation (DIC)	5.6% 1/18 • Number of events 1 • 2 years
Gastrointestinal disorders Colon and caecum inflammation (typhilitis, colitis)	5.6% 1/18 • Number of events 1 • 2 years
Hepatobiliary disorders Hepatobilliary Disorders-Other, veno-occlusive disease	5.6% 1/18 • Number of events 1 • 2 years
Infections and infestations Septic shock (sepsis)	27.8% 5/18 • Number of events 5 • 2 years
Nervous system disorders Intracranial hemorrhage	5.6% 1/18 • Number of events 1 • 2 years

Other adverse events

Other adverse events
Measure	Bortezomib + Chemotherapy n=18 participants at risk Patients receive bortezomib on Days 1, 4, 8, and 11; doxorubicin hydrochloride on Day 1; PEG-asparaginase on Days 5 and 22; vincristine sulfate on Days 1, 8, 15, and 22; dexamethasone daily on Days 1 to 14; cytarabine on Day 1, and methotrexate on Day 15. Bortezomib: Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11. Doxorubicin hydrochloride (HCl): Administered intravenously (IV) over 15 min at 60mg/m², on Day 1. PEG-Asparaginase: Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22. Vincristine sulfate: Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22. Dexamethasone: Administered orally (PO) at 10 mg/m², daily on Days 1 to 14. Cytarabine: Administered intrathecally (IT) at 100 mg, on Day 1 Methotrexate: Administered intrathecally (IT) at 15 mg, on Day 15.
Blood and lymphatic system disorders Neutropenic fever (febrile neutropenia)	27.8% 5/18 • Number of events 5 • 2 years
Blood and lymphatic system disorders Neutropenia	72.2% 13/18 • Number of events 13 • 2 years
Blood and lymphatic system disorders Lymphopenia	72.2% 13/18 • Number of events 13 • 2 years
Blood and lymphatic system disorders Anemia	88.9% 16/18 • Number of events 16 • 2 years
Blood and lymphatic system disorders Thrombocytopenia	66.7% 12/18 • Number of events 12 • 2 years
Cardiac disorders Heart palpitations (tachycardia)	16.7% 3/18 • Number of events 3 • 2 years
Cardiac disorders Heart failure (congestive heart failure)	11.1% 2/18 • Number of events 2 • 2 years
Ear and labyrinth disorders Decreased hearing (hearing impaired)	5.6% 1/18 • Number of events 1 • 2 years
Eye disorders Blurred vision	16.7% 3/18 • Number of events 3 • 2 years
Eye disorders Dry eyes	5.6% 1/18 • Number of events 1 • 2 years
Gastrointestinal disorders Pancreatitis	5.6% 1/18 • Number of events 1 • 2 years
Gastrointestinal disorders Vomiting (nausea)	72.2% 13/18 • Number of events 13 • 2 years
Gastrointestinal disorders Mucositis oral	22.2% 4/18 • Number of events 4 • 2 years
Gastrointestinal disorders Constipation	38.9% 7/18 • Number of events 7 • 2 years
Gastrointestinal disorders Gastroesophageal reflux disease (GERD)	38.9% 7/18 • Number of events 7 • 2 years
Gastrointestinal disorders Diarrhea	33.3% 6/18 • Number of events 6 • 2 years
Gastrointestinal disorders Colon and caecum inflammation (typhilitis, colitis)	27.8% 5/18 • Number of events 5 • 2 years
Gastrointestinal disorders Abdominal pain	55.6% 10/18 • Number of events 10 • 2 years
Gastrointestinal disorders Perianal pain ( Anal pain)	11.1% 2/18 • Number of events 2 • 2 years
Gastrointestinal disorders Rectal hemorrhage	11.1% 2/18 • Number of events 2 • 2 years
General disorders Swelling (edema)	50.0% 9/18 • Number of events 9 • 2 years
General disorders Fatigue	38.9% 7/18 • Number of events 7 • 2 years
General disorders Chills	11.1% 2/18 • Number of events 2 • 2 years
Hepatobiliary disorders Hepatobilliary Disorders-Other, liver abscess	5.6% 1/18 • Number of events 1 • 2 years
Infections and infestations Infections and infestations-Other,thrush	16.7% 3/18 • Number of events 3 • 2 years
Infections and infestations Respiratory infections	44.4% 8/18 • Number of events 8 • 2 years
Infections and infestations Infections and infestations-Other, Herpes simplex virus	11.1% 2/18 • Number of events 2 • 2 years
Infections and infestations Septic shock (sepsis)	5.6% 1/18 • Number of events 1 • 2 years
Infections and infestations Respiratory syncytial virus (RSV)	5.6% 1/18 • Number of events 1 • 2 years
Infections and infestations Skin infection	16.7% 3/18 • Number of events 3 • 2 years
Infections and infestations Infections and infestations-Other, Herpes simplex virus Line, sepsis	27.8% 5/18 • Number of events 5 • 2 years
Investigations Fibrinogen decreased	94.4% 17/18 • Number of events 17 • 2 years
Investigations Partial thromboplastin time (PTT) high	38.9% 7/18 • Number of events 7 • 2 years
Investigations Aspartate aminotransferase (AST) elevated	77.8% 14/18 • Number of events 14 • 2 years
Investigations Alanine aminotransferase (ALT) elevated	83.3% 15/18 • Number of events 15 • 2 years
Investigations Bilirubin elevated	61.1% 11/18 • Number of events 11 • 2 years
Investigations Alkaline Phosphatase elevated	50.0% 9/18 • Number of events 9 • 2 years
Investigations Gamma-glutamyl transferase (GGT) elevated	11.1% 2/18 • Number of events 2 • 2 years
Investigations Amylase high	16.7% 3/18 • Number of events 3 • 2 years
Investigations Lipase high	33.3% 6/18 • Number of events 6 • 2 years
Investigations Creatinine high	38.9% 7/18 • Number of events 7 • 2 years
Metabolism and nutrition disorders Apetite loss (anorexia)	27.8% 5/18 • Number of events 5 • 2 years
Metabolism and nutrition disorders Hypoalbuminemia (Albumin low)	100.0% 18/18 • Number of events 18 • 2 years
Metabolism and nutrition disorders Hypertriglyceridemia (Triglycerides high)	11.1% 2/18 • Number of events 2 • 2 years
Metabolism and nutrition disorders Hypernatremia -Sodium high	11.1% 2/18 • Number of events 2 • 2 years
Metabolism and nutrition disorders Hyponatremia -Sodium low	27.8% 5/18 • Number of events 5 • 2 years
Metabolism and nutrition disorders Hypokalemia -Potassium low	66.7% 12/18 • Number of events 12 • 2 years
Metabolism and nutrition disorders Hyperkalemia -Potassium high	5.6% 1/18 • Number of events 1 • 2 years
Metabolism and nutrition disorders Hypomagnesemia -Magnesium low	50.0% 9/18 • Number of events 9 • 2 years
Metabolism and nutrition disorders Hypocalcemia -Calcium low	72.2% 13/18 • Number of events 13 • 2 years
Metabolism and nutrition disorders Hypophosphatemia -Phosphorus low	50.0% 9/18 • Number of events 9 • 2 years
Metabolism and nutrition disorders Metabolism and Nutrition Disorders-Other Phosphorus high	5.6% 1/18 • Number of events 1 • 2 years
Metabolism and nutrition disorders Hyperglycemia (Glucose high)	72.2% 13/18 • Number of events 13 • 2 years
Metabolism and nutrition disorders Hypoglycemia -Glucose low	16.7% 3/18 • Number of events 3 • 2 years
Musculoskeletal and connective tissue disorders Leg weakness (generalized muscle weakness )	5.6% 1/18 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, musculoskeletal Pain	72.2% 13/18 • Number of events 13 • 2 years
Musculoskeletal and connective tissue disorders Avascular necrosis (Bone infarct)	5.6% 1/18 • Number of events 1 • 2 years
Nervous system disorders Dizziness	16.7% 3/18 • Number of events 3 • 2 years
Nervous system disorders Peripheral motor neuropathy	11.1% 2/18 • Number of events 2 • 2 years
Nervous system disorders Peripheral sensory neuropathy	44.4% 8/18 • Number of events 8 • 2 years
Nervous system disorders Seizures	5.6% 1/18 • Number of events 1 • 2 years
Nervous system disorders Leukoencephalopathy	5.6% 1/18 • Number of events 1 • 2 years
Nervous system disorders Ataxia	5.6% 1/18 • Number of events 1 • 2 years
Nervous system disorders Restless leg (akathisia)	5.6% 1/18 • Number of events 1 • 2 years
Nervous system disorders Syncope	5.6% 1/18 • Number of events 1 • 2 years
Nervous system disorders Headache	72.2% 13/18 • Number of events 13 • 2 years
Nervous system disorders Intracranial hemorrhage	11.1% 2/18 • Number of events 2 • 2 years
Psychiatric disorders Insomnia	16.7% 3/18 • Number of events 3 • 2 years
Psychiatric disorders Confusion	16.7% 3/18 • Number of events 3 • 2 years
Psychiatric disorders Depression	11.1% 2/18 • Number of events 2 • 2 years
Psychiatric disorders Anxiety	5.6% 1/18 • Number of events 1 • 2 years
Renal and urinary disorders Urinary retention	5.6% 1/18 • Number of events 1 • 2 years
Renal and urinary disorders Pain during urination (dysuria)	5.6% 1/18 • Number of events 1 • 2 years
Reproductive system and breast disorders Scrotal pain	5.6% 1/18 • Number of events 1 • 2 years
Reproductive system and breast disorders Vaginal hemorrhage	5.6% 1/18 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Cough	11.1% 2/18 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Breath shortness (Dyspnea)	5.6% 1/18 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Hiccups	11.1% 2/18 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Chest pain (pleuritic pain)	5.6% 1/18 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Nosebleed (Epistaxis)	16.7% 3/18 • Number of events 3 • 2 years
Skin and subcutaneous tissue disorders Rash	22.2% 4/18 • Number of events 4 • 2 years
Skin and subcutaneous tissue disorders Pruritus	11.1% 2/18 • Number of events 2 • 2 years
Skin and subcutaneous tissue disorders Skin ulceration -Lip lesion	5.6% 1/18 • Number of events 1 • 2 years
Vascular disorders High blood pressure (hypertension)	11.1% 2/18 • Number of events 2 • 2 years
Vascular disorders Low blood pressure (hyportension)	27.8% 5/18 • Number of events 5 • 2 years

Additional Information

Michaela Liedtke, MD

Stanford University Medical Center

Phone: 650-498-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place