Trial Outcomes & Findings for Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML) (NCT NCT01184898)
NCT ID: NCT01184898
Last Updated: 2025-05-31
Results Overview
Percent change compared between response groups (responder vs nonresponder). This outcome measure only includes patients who survived to outcome assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
From pre- to post-treatment
Results posted on
2025-05-31
Participant Flow
Participant milestones
| Measure |
Sirolimus and MEC
Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Sirolimus and MEC
n=36 Participants
Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses.
|
|---|---|
|
Age, Continuous
|
60.05 years
STANDARD_DEVIATION 11.84 • n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From pre- to post-treatmentPercent change compared between response groups (responder vs nonresponder). This outcome measure only includes patients who survived to outcome assessment.
Outcome measures
| Measure |
Sirolimus and MEC
n=27 Participants
Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses.
|
|---|---|
|
Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC
Nonresponders (10 pts)
|
-36 percentage change in leukemic blasts
Interval -225.0 to 32.0
|
|
Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC
Responders (17 pts)
|
69 percentage change in leukemic blasts
Interval 42.0 to 98.0
|
SECONDARY outcome
Timeframe: Within one week of peripheral count recovery but no later than day 42Complete response is defined as: * Peripheral Blood Counts -Neutrophil count \>1 x 109/L. * Platelet count ≥ 100 x 109/L. * Reduced hemoglobin concentration or hematocrit has no bearing on remission status. * Leukemic blasts must not be present in the peripheral blood. * Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines with \< 5% blasts and no Auer rods. * Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present
Outcome measures
| Measure |
Sirolimus and MEC
n=34 Participants
Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses.
|
|---|---|
|
Complete Response
|
11 participants
|
SECONDARY outcome
Timeframe: Within one week of peripheral count recovery but no later than day 42Complete response in the absence of platelet recovery is defined as: \- Bone marrow (\<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)
Outcome measures
| Measure |
Sirolimus and MEC
n=34 Participants
Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses.
|
|---|---|
|
Complete Response in the Absence of Platelet Recovery
|
2 participants
|
SECONDARY outcome
Timeframe: Within one week of peripheral count recovery but no later than day 42Partial response is defined as: * Requires that all of the criteria for complete remission be satisfied except that the bone marrow may contain ≥ 5% blasts but \< 25% blasts. * A marrow with \<5% blasts that contain Auer rods will also be considered a PR
Outcome measures
| Measure |
Sirolimus and MEC
n=34 Participants
Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses.
|
|---|---|
|
Partial Response
|
3 participants
|
Adverse Events
Sirolimus and MEC
Serious events: 8 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sirolimus and MEC
n=36 participants at risk
Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses.
|
|---|---|
|
General disorders
Infection
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Bone marrow cellularity
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Abdominal pain
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Prolonged QTc interval
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Sepsis
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Multi-organ failure
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory syncytial virus
|
2.8%
1/36 • Number of events 1
|
Other adverse events
| Measure |
Sirolimus and MEC
n=36 participants at risk
Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)
Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses.
|
|---|---|
|
General disorders
Chest pain
|
22.2%
8/36 • Number of events 12
|
|
General disorders
Sore throat
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Cough
|
58.3%
21/36 • Number of events 39
|
|
General disorders
Back pain
|
33.3%
12/36 • Number of events 15
|
|
General disorders
Nausea
|
77.8%
28/36 • Number of events 47
|
|
General disorders
Pain from bone marrow biopsy
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
18/36 • Number of events 24
|
|
General disorders
Fever
|
16.7%
6/36 • Number of events 6
|
|
General disorders
Generalized achiness
|
5.6%
2/36 • Number of events 3
|
|
Cardiac disorders
Tachycardia
|
47.2%
17/36 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Rash
|
63.9%
23/36 • Number of events 35
|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
30/36 • Number of events 49
|
|
General disorders
Neck pain
|
11.1%
4/36 • Number of events 7
|
|
General disorders
Lightheadedness
|
8.3%
3/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Hypotension
|
33.3%
12/36 • Number of events 17
|
|
General disorders
Fatigue
|
83.3%
30/36 • Number of events 63
|
|
Blood and lymphatic system disorders
Pancytopenia
|
22.2%
8/36 • Number of events 8
|
|
General disorders
Chills
|
36.1%
13/36 • Number of events 17
|
|
General disorders
Headache
|
38.9%
14/36 • Number of events 18
|
|
Psychiatric disorders
Anxiety
|
36.1%
13/36 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Edema
|
77.8%
28/36 • Number of events 55
|
|
General disorders
Insomnia
|
36.1%
13/36 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Joint pain/stiffness
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Unsteady gait
|
13.9%
5/36 • Number of events 5
|
|
Infections and infestations
Infection
|
41.7%
15/36 • Number of events 22
|
|
General disorders
Night sweats
|
8.3%
3/36 • Number of events 5
|
|
General disorders
Bleeding gums
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cellultitis
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Lesions
|
13.9%
5/36 • Number of events 6
|
|
General disorders
Pain at PICC site
|
8.3%
3/36 • Number of events 4
|
|
General disorders
Stomach pain
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Gum pain
|
11.1%
4/36 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Bruising
|
22.2%
8/36 • Number of events 11
|
|
Gastrointestinal disorders
Constipation
|
30.6%
11/36 • Number of events 14
|
|
General disorders
Hoarseness
|
5.6%
2/36 • Number of events 2
|
|
Renal and urinary disorders
Urinary frequency
|
22.2%
8/36 • Number of events 8
|
|
Gastrointestinal disorders
Mucositis
|
44.4%
16/36 • Number of events 25
|
|
General disorders
Fungal pneumonia
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
52.8%
19/36 • Number of events 31
|
|
General disorders
Blotchy face with itchiness
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Hip pain
|
13.9%
5/36 • Number of events 5
|
|
General disorders
Decreased appetite
|
19.4%
7/36 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.6%
2/36 • Number of events 2
|
|
Psychiatric disorders
Mental status change/confusion
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
61.1%
22/36 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
Itching
|
33.3%
12/36 • Number of events 14
|
|
Gastrointestinal disorders
Vomiting
|
36.1%
13/36 • Number of events 15
|
|
General disorders
Throat discomfort
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Stool incontinence
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Abdominal pain
|
41.7%
15/36 • Number of events 21
|
|
Gastrointestinal disorders
Typhlitis
|
13.9%
5/36 • Number of events 5
|
|
General disorders
Difficulty swallowing
|
11.1%
4/36 • Number of events 4
|
|
General disorders
Head pain
|
5.6%
2/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Hypertension
|
25.0%
9/36 • Number of events 15
|
|
General disorders
Dizziness
|
22.2%
8/36 • Number of events 8
|
|
General disorders
Dry heaves
|
8.3%
3/36 • Number of events 3
|
|
Cardiac disorders
Heart irregularity
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
Low urine output
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Generalized weakness
|
30.6%
11/36 • Number of events 12
|
|
General disorders
Rigors
|
11.1%
4/36 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
4/36 • Number of events 4
|
|
Immune system disorders
Sepsis
|
11.1%
4/36 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
3/36 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
13.9%
5/36 • Number of events 6
|
|
General disorders
Burning sensation
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Shoulder pain
|
13.9%
5/36 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Sweats
|
27.8%
10/36 • Number of events 10
|
|
General disorders
Eye pain
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Bone pain
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Arm pain
|
16.7%
6/36 • Number of events 7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.8%
10/36 • Number of events 14
|
|
Nervous system disorders
Neuropathy
|
11.1%
4/36 • Number of events 5
|
|
General disorders
Trouble sleeping
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Gas pains
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Bloating
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Alopecia
|
13.9%
5/36 • Number of events 9
|
|
Psychiatric disorders
Depression
|
11.1%
4/36 • Number of events 6
|
|
Nervous system disorders
Numbness/tingling
|
11.1%
4/36 • Number of events 4
|
|
General disorders
Muscle ache/pain
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Post nasal drip
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Dry oropharynx
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Folliculitis
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Mouth ulcer
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Tooth pain
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Fullness sensation in stomach
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Mouth soreness
|
8.3%
3/36 • Number of events 5
|
|
General disorders
Pain with ambulation
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Esophageal discomfort
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Breathing difficulty
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lobar pneumonia
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypokalemia
|
44.4%
16/36 • Number of events 48
|
|
General disorders
Epistaxis
|
22.2%
8/36 • Number of events 13
|
|
Renal and urinary disorders
Hematuria
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Chest pain upon cough
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Sinus congestion
|
5.6%
2/36 • Number of events 2
|
|
Eye disorders
Floaters in both eyes
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Anal fissure
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
3/36 • Number of events 7
|
|
General disorders
Elevated creatinine level
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Bilateral cracks in lung
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Fullness in abdomen upon cough
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Swollen throat/pharyngeal abscess
|
2.8%
1/36 • Number of events 2
|
|
General disorders
Upper extremity swelling
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Decreased musculature
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Bleeding
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombosis
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Jaw swelling
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Tongue pain
|
5.6%
2/36 • Number of events 3
|
|
General disorders
Dry mouth
|
16.7%
6/36 • Number of events 8
|
|
Psychiatric disorders
Hallucinations
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Coarse lung sounds
|
8.3%
3/36 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Decreased breath sounds
|
8.3%
3/36 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
16.7%
6/36 • Number of events 10
|
|
General disorders
Periodontal disease
|
5.6%
2/36 • Number of events 5
|
|
General disorders
Leg pain
|
16.7%
6/36 • Number of events 6
|
|
General disorders
Anorexia
|
58.3%
21/36 • Number of events 32
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Generalized pain
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Dry mucous membrane
|
5.6%
2/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
22.2%
8/36 • Number of events 31
|
|
General disorders
Throat pain
|
19.4%
7/36 • Number of events 14
|
|
General disorders
Lip pain
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Decreased range of motion
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Abdominal tenderness
|
8.3%
3/36 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Spinal change
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
B-12 deficiency
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
9/36 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Pelvis pain
|
2.8%
1/36 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Distension
|
11.1%
4/36 • Number of events 5
|
|
Nervous system disorders
Saddle anesthesia
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Redness at PICC site
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Taste alteration
|
8.3%
3/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
30.6%
11/36 • Number of events 36
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
11.1%
4/36 • Number of events 6
|
|
General disorders
Thrush
|
13.9%
5/36 • Number of events 7
|
|
Cardiac disorders
Heart murmur
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperphosphatemia
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Pancolitis
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary nodules
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Ears popping
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Ear pain
|
5.6%
2/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Decreased pH
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Cracked tooth
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
30.6%
11/36 • Number of events 24
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
8.3%
3/36 • Number of events 4
|
|
General disorders
Umbilical hernia
|
2.8%
1/36 • Number of events 1
|
|
Hepatobiliary disorders
Increased LFTs
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Hot flashes
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Obesity
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Weight loss
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
Fluid overload
|
2.8%
1/36 • Number of events 1
|
|
Hepatobiliary disorders
Increased aspartate aminotransferase
|
11.1%
4/36 • Number of events 7
|
|
General disorders
Reducible central hernia
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Tremor
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Cold sore
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
2/36 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Hypoxia
|
8.3%
3/36 • Number of events 6
|
|
General disorders
Decreased electrolytes
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Eyelid dysfunction
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Sinus pain
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyponatremia
|
19.4%
7/36 • Number of events 17
|
|
Eye disorders
Dry eyes
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Acute infusion reaction
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Hemhorrage
|
13.9%
5/36 • Number of events 13
|
|
Blood and lymphatic system disorders
Hypernatremia
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Increased alkaline phosphatase
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Increased alanine aminotransferase
|
5.6%
2/36 • Number of events 3
|
|
General disorders
Weight gain
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Slightly muddy sclera
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Heart failure
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
5.6%
2/36 • Number of events 2
|
|
Hepatobiliary disorders
Decreased fibrinogen
|
8.3%
3/36 • Number of events 4
|
|
General disorders
Knee pain
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Rhinitis
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Change in signature
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Elevated cardiac troponin
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Jaw pain
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Blister on tongue
|
2.8%
1/36 • Number of events 8
|
|
Infections and infestations
Blood infection
|
2.8%
1/36 • Number of events 2
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
2.8%
1/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.8%
1/36 • Number of events 1
|
|
General disorders
MSSA VRE (infection)
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hives
|
5.6%
2/36 • Number of events 2
|
|
Ear and labyrinth disorders
Cholesteatoma
|
2.8%
1/36 • Number of events 4
|
|
Cardiac disorders
Heart palpitations
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
27.8%
10/36 • Number of events 22
|
|
Blood and lymphatic system disorders
Decreased hemoglobin
|
27.8%
10/36 • Number of events 15
|
|
General disorders
Increased INR (international normalized ratio)
|
5.6%
2/36 • Number of events 7
|
|
Blood and lymphatic system disorders
Hyopalbuminemia
|
19.4%
7/36 • Number of events 40
|
|
General disorders
Increased PTT (partial thromboblastin time)
|
8.3%
3/36 • Number of events 7
|
|
Blood and lymphatic system disorders
Leukopenia
|
27.8%
10/36 • Number of events 16
|
|
General disorders
Sinusitis
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Facial pain
|
5.6%
2/36 • Number of events 3
|
|
General disorders
Vaginal bleeding
|
2.8%
1/36 • Number of events 2
|
|
General disorders
General incontinence
|
5.6%
2/36 • Number of events 3
|
|
Renal and urinary disorders
Dysuria
|
2.8%
1/36 • Number of events 2
|
|
General disorders
Hemorrhoid pain
|
5.6%
2/36 • Number of events 3
|
|
Psychiatric disorders
Flat affect
|
2.8%
1/36 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
2.8%
1/36 • Number of events 3
|
|
General disorders
Mouth pain
|
5.6%
2/36 • Number of events 7
|
|
Infections and infestations
Yeast infection
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.8%
1/36 • Number of events 3
|
|
General disorders
Dehydration
|
16.7%
6/36 • Number of events 7
|
|
General disorders
Groin pain
|
2.8%
1/36 • Number of events 6
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Non-occlusive clot
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypermagnesemia
|
5.6%
2/36 • Number of events 3
|
|
General disorders
Increased PT (prothrombin time)
|
2.8%
1/36 • Number of events 9
|
|
General disorders
Hemorrhoids
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
2.8%
1/36 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Macular rash
|
2.8%
1/36 • Number of events 1
|
|
Hepatobiliary disorders
Low creatinine
|
5.6%
2/36 • Number of events 2
|
|
General disorders
Hiccups
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Abdominal cramping
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypouricemia
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Esophagitis
|
2.8%
1/36 • Number of events 2
|
|
Hepatobiliary disorders
High creatinine
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Restlessness in legs
|
2.8%
1/36 • Number of events 1
|
|
Eye disorders
Blurred vision
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular atrophy
|
2.8%
1/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Gram-negative bacteria
|
2.8%
1/36 • Number of events 2
|
|
Ear and labyrinth disorders
JVT (Jahn ventilating tube) to ears
|
2.8%
1/36 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place