Trial Outcomes & Findings for Azacitidine and Entinostat in Treating Patients With Recurrent Advanced Non-Small Cell Lung Cancer (NCT NCT00387465)
NCT ID: NCT00387465
Last Updated: 2019-05-09
Results Overview
DLT is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
COMPLETED
PHASE1/PHASE2
94 participants
Up to 28 days
2019-05-09
Participant Flow
49 subjects did not start the study due to screen failure or PI decision.
Participant milestones
| Measure |
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase II Arm
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
35
|
|
Overall Study
COMPLETED
|
3
|
6
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase II Arm
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Azacitidine and Entinostat in Treating Patients With Recurrent Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase II Arm
n=35 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
n=3 Participants
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
n=7 Participants
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Only participants in the Phase I arms were analyzed for this outcome measure
DLT is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Outcome measures
| Measure |
Phase II Arm
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
n=3 Participants
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
n=6 Participants
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
(Phase I) Maximum Tolerated Dose (MTD) of Azacitidine When Given Together With Entinostat as Determined by Number of Participants Experiencing Dose-limiting Toxicity (DLT)
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: Only participants who received Azacitidine 40mg/m2 and completed at least one cycle of therapy were evaluable for this outcome measure.
Number of participants with progressive disease (PD), stable disease (SD), complete response (CR), or partial response (PR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0), after completing at least one cycle of therapy. Per RECIST 1.0, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR is defined as \>=30% decrease in the sum of the longest diameter of target lesions, CR is defined as the disappearance of all target lesions.
Outcome measures
| Measure |
Phase II Arm
n=34 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
(Phase II) Objective Response Rate After Treatment With Azacitidine and Entinostat as Assessed by Number of Participants With Response After at Least One Cycle of Therapy
CR
|
1 Participants
|
—
|
—
|
|
(Phase II) Objective Response Rate After Treatment With Azacitidine and Entinostat as Assessed by Number of Participants With Response After at Least One Cycle of Therapy
PD
|
22 Participants
|
—
|
—
|
|
(Phase II) Objective Response Rate After Treatment With Azacitidine and Entinostat as Assessed by Number of Participants With Response After at Least One Cycle of Therapy
PR
|
1 Participants
|
—
|
—
|
|
(Phase II) Objective Response Rate After Treatment With Azacitidine and Entinostat as Assessed by Number of Participants With Response After at Least One Cycle of Therapy
SD
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and days 10 and 29Population: Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. However, data was evaluable in only 26/42 participants.
Number of participants with decrease in DNA methylation ("methylation-signature positive") on Day 10 or Day 29, and either stable disease or objective response (OR) as defined by RECIST 1.0. Per RECIST 1.0, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR is defined as \>=30% decrease in the sum of the longest diameter of target lesions, complete response is defined as disappearance of all target lesions; OR=CR+PR.
Outcome measures
| Measure |
Phase II Arm
n=26 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Effect of Entinostat and Azacitidine on DNA Methylation and Response
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 yearsPopulation: Only participants who received 40mg/m2 azacitidine and at least 1 cycle of subsequent chemotherapy (19 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. However, 2/19 deceased prior to imaging and therefore were not evaluable for this outcome measure.
Number of participants with progressive disease (PD), stable disease (SD), or partial response (PR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) after at least 1 cycle of subsequent chemotherapy. Per RECIST 1.0, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; PR is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Phase II Arm
n=17 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Major Objective Response After Immediate Subsequent Therapy as Measured by Number of Participants With PR, SD, PD After at Least 1 Cycle of Subsequent Chemotherapy
PR
|
4 Participants
|
—
|
—
|
|
Major Objective Response After Immediate Subsequent Therapy as Measured by Number of Participants With PR, SD, PD After at Least 1 Cycle of Subsequent Chemotherapy
SD
|
9 Participants
|
—
|
—
|
|
Major Objective Response After Immediate Subsequent Therapy as Measured by Number of Participants With PR, SD, PD After at Least 1 Cycle of Subsequent Chemotherapy
PD
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Only participants who received Azacitidine 40mg/m2 were evaluable for this outcome measure.
Determined by the method determined by Kaplan and Meier. 95% confidence intervals will be estimated.
Outcome measures
| Measure |
Phase II Arm
n=42 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Overall Survival
|
6.4 months
Interval 3.8 to 9.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants.
Time to maximal concentration of azacitidine in the blood.
Outcome measures
| Measure |
Phase II Arm
n=40 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Pharmacokinetic Profile of Azacytidine as Measured by Tmax
|
0.5 hours
Interval 0.25 to 2.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Only participants who received Azacitidine 40mg/m2 were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Determined by the method determined by Kaplan and Meier. 95% confidence intervals will be estimated.
Outcome measures
| Measure |
Phase II Arm
n=42 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Progression-free Survival
|
7.4 weeks
Interval 7.0 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants
Maximal concentration (ng/mL) of azacitidine
Outcome measures
| Measure |
Phase II Arm
n=40 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Pharmacokinetic Profile of Azacitidine as Measured by Cmax
|
468 ng/mL
Standard Deviation 241
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants.
Outcome measures
| Measure |
Phase II Arm
n=40 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Pharmacokinetic Profile of Azacitidine as Measured by AUC (ng*hr/mL)
|
675 ng*hr/mL
Standard Deviation 290
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 and 17Population: Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants.
Outcome measures
| Measure |
Phase II Arm
n=40 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Average Steady State Trough Concentration (ng/mL) of Entinostat
Day 10
|
0.84 ng/mL
Standard Deviation 0.23
|
—
|
—
|
|
Average Steady State Trough Concentration (ng/mL) of Entinostat
Day 17
|
1.10 ng/mL
Standard Deviation 0.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Only participants who received Azacitidine 40mg/m2 (42 participants) were assessed for this outcome measure. Therefore, data was not collected from the participants in the 30mg/m2 arm from Phase I. Data was not collected from 2/42 participants.
Outcome measures
| Measure |
Phase II Arm
n=40 Participants
Patients receive azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
Phase I - 40mg/m2 Azacitidine
Patients receive azacitidine 40mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|---|
|
Pharmacokinetic Profile of Azacitidine as Measured by Half-life
|
1.12 hours
Standard Deviation 1.06
|
—
|
—
|
Adverse Events
Azacitidine 40mg/m2 and Entinostat
Phase I - 30mg/m2 Azacitidine
Serious adverse events
| Measure |
Azacitidine 40mg/m2 and Entinostat
n=42 participants at risk
Patients from both Phase I and II who received azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
n=3 participants at risk
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.8%
2/42
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/42
|
0.00%
0/3
|
|
Cardiac disorders
Pericardial Tamponade
|
2.4%
1/42
|
0.00%
0/3
|
Other adverse events
| Measure |
Azacitidine 40mg/m2 and Entinostat
n=42 participants at risk
Patients from both Phase I and II who received azacitidine 40mg/m2 subcutaneously (SQ) on days 1-6 and 8-10 and entinostat 7mg PO on days 3 and 10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase I - 30mg/m2 Azacitidine
n=3 participants at risk
Patients receive Azacitidine 30mg/m2 SQ and entinostat 7mg PO on days 3 and 10 of each cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
47.6%
20/42
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
7/42
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
31.0%
13/42
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutropenai
|
7.1%
3/42
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.9%
5/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
6/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
35.7%
15/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
7/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
47.6%
20/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
11/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
3/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
7/42
|
0.00%
0/3
|
|
General disorders
Anorexia
|
38.1%
16/42
|
0.00%
0/3
|
|
General disorders
Dyspnea
|
21.4%
9/42
|
0.00%
0/3
|
|
General disorders
Fatigue
|
59.5%
25/42
|
0.00%
0/3
|
|
General disorders
Chills
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Left chest pain
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Injection site reaction
|
59.5%
25/42
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary Tract infection
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Dizziness
|
26.2%
11/42
|
0.00%
0/3
|
|
General disorders
Hemmorhoids
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Blurred Vision
|
4.8%
2/42
|
0.00%
0/3
|
|
Psychiatric disorders
Confusion
|
7.1%
3/42
|
0.00%
0/3
|
|
General disorders
Preformance status decline
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Aphasia
|
2.4%
1/42
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pitting edema
|
2.4%
1/42
|
0.00%
0/3
|
|
Cardiac disorders
Hypotension
|
16.7%
7/42
|
0.00%
0/3
|
|
Hepatobiliary disorders
Albumin
|
28.6%
12/42
|
0.00%
0/3
|
|
Hepatobiliary disorders
Alk Phos
|
21.4%
9/42
|
0.00%
0/3
|
|
Hepatobiliary disorders
AST
|
4.8%
2/42
|
0.00%
0/3
|
|
Hepatobiliary disorders
ALT
|
4.8%
2/42
|
0.00%
0/3
|
|
Hepatobiliary disorders
Bilirubin
|
7.1%
3/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
18/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.1%
3/42
|
0.00%
0/3
|
|
General disorders
Cough
|
4.8%
2/42
|
0.00%
0/3
|
|
General disorders
Hypoxic
|
2.4%
1/42
|
0.00%
0/3
|
|
Cardiac disorders
Tachycardia
|
7.1%
3/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dehydration
|
7.1%
3/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Weight loss
|
11.9%
5/42
|
0.00%
0/3
|
|
General disorders
Uric Acid
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Elevated creatinine
|
11.9%
5/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/42
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Inter. Muscle Spasm
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Hyperkalemia
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Hypermagnesemia
|
4.8%
2/42
|
0.00%
0/3
|
|
Cardiac disorders
Heartburn
|
4.8%
2/42
|
0.00%
0/3
|
|
Gastrointestinal disorders
Upset stomach
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Insomnia
|
9.5%
4/42
|
0.00%
0/3
|
|
Psychiatric disorders
Depression or Anxiety
|
11.9%
5/42
|
0.00%
0/3
|
|
General disorders
Fever
|
9.5%
4/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.4%
1/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.9%
5/42
|
0.00%
0/3
|
|
General disorders
Somnolence
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Aches
|
4.8%
2/42
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphetemia
|
9.5%
4/42
|
0.00%
0/3
|
|
General disorders
Throat Pain
|
2.4%
1/42
|
0.00%
0/3
|
|
Cardiac disorders
A.filbrillation
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
GIB
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Weakness
|
4.8%
2/42
|
0.00%
0/3
|
|
General disorders
Pleural Effusion
|
7.1%
3/42
|
0.00%
0/3
|
|
General disorders
Headache
|
7.1%
3/42
|
0.00%
0/3
|
|
General disorders
Stroke
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Lung Infection
|
4.8%
2/42
|
0.00%
0/3
|
|
General disorders
Myositis
|
2.4%
1/42
|
0.00%
0/3
|
|
General disorders
Neuropathy
|
2.4%
1/42
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60