Trial Outcomes & Findings for Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia (NCT NCT01253070)
NCT ID: NCT01253070
Last Updated: 2022-08-04
Results Overview
Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
1 year
Results posted on
2022-08-04
Participant Flow
A total of 54 participants were recruited from April 2011 to August 2013.
Participant milestones
| Measure |
Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
n=54 Participants
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
|---|---|
|
Age, Continuous
|
67.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
|
FLT3 Mutation
ITD
|
39 participants
n=5 Participants
|
|
FLT3 Mutation
TKD
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Three participants withdrew consent to protocol treatment and follow-up prior to 1 year post registration (2 ITD; 1 TKD). These participants have been excluded from the primary endpoint analysis.
Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.
Outcome measures
| Measure |
ITD Mutated Participants
n=37 Participants
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
TKD Mutated Participants
n=14 Participants
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
|---|---|---|
|
Overall Survival (OS) Rate
|
62 percentage of participants
Interval 45.0 to 78.0
|
71 percentage of participants
Interval 42.0 to 92.0
|
SECONDARY outcome
Timeframe: Time from registration to death (up to 10 years)OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
ITD Mutated Participants
n=39 Participants
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
TKD Mutated Participants
n=15 Participants
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
|---|---|---|
|
OS
|
15 months
Interval 10.4 to 20.1
|
16.2 months
Interval 5.0 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
|
SECONDARY outcome
Timeframe: Time from registration to death or relapse (up to 10 years)Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
ITD Mutated Participants
n=39 Participants
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
TKD Mutated Participants
n=15 Participants
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
|---|---|---|
|
Event-free Survival
|
8.8 months
Interval 3.0 to 13.9
|
7.8 months
Interval 1.3 to 11.6
|
Adverse Events
Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
Serious events: 21 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
n=50 participants at risk
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
|---|---|
|
Nervous system disorders
Seizure
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
4/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
5/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Ataxia
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Dysarthria
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Lethargy
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Nervous system disorders - Other
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
20/50 • Number of events 24
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
26.0%
13/50 • Number of events 15
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
5/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Atrioventricular block first degree
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Cardiac arrest
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Cardiac disorders - Other
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Heart failure
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Pericarditis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Sinus bradycardia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Ventricular arrhythmia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Eye disorders
Blurred vision
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Eye disorders
Dry eye
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Eye disorders
Eye disorders - Other
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
6/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Constipation
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Diarrhea
|
28.0%
14/50 • Number of events 14
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Mucositis oral
|
14.0%
7/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Nausea
|
14.0%
7/50 • Number of events 9
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Rectal pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Chills
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Edema limbs
|
14.0%
7/50 • Number of events 9
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Fatigue
|
22.0%
11/50 • Number of events 13
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Fever
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Localized edema
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Multi-organ failure
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Pain
|
4.0%
2/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Bone infection
|
2.0%
1/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Enterocolitis infectious
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Infections and infestations - Other
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Laryngitis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Lip infection
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Lung infection
|
16.0%
8/50 • Number of events 10
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Sepsis
|
12.0%
6/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
8/50 • Number of events 8
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
6/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Aspartate aminotransferase increased
|
22.0%
11/50 • Number of events 11
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Blood bilirubin increased
|
16.0%
8/50 • Number of events 8
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Creatinine increased
|
10.0%
5/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Ejection fraction decreased
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
INR increased
|
8.0%
4/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Investigations - Other
|
4.0%
2/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Lymphocyte count decreased
|
16.0%
8/50 • Number of events 10
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Neutrophil count decreased
|
38.0%
19/50 • Number of events 22
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Platelet count decreased
|
40.0%
20/50 • Number of events 23
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Urine output decreased
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Weight gain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Weight loss
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
White blood cell decreased
|
28.0%
14/50 • Number of events 15
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Acidosis
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.0%
8/50 • Number of events 9
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.0%
11/50 • Number of events 11
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
26.0%
13/50 • Number of events 16
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.0%
11/50 • Number of events 11
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
10/50 • Number of events 10
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
5/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.0%
11/50 • Number of events 13
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.0%
8/50 • Number of events 11
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Transient ischemic attacks
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Anxiety
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Confusion
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Insomnia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Hematuria
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Proteinuria
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Renal calculi
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
5/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
10/50 • Number of events 13
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Hematoma
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Hypertension
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Hypotension
|
10.0%
5/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Thromboembolic event
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Vascular disorders - Other
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
Other adverse events
| Measure |
Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)
n=50 participants at risk
INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m\^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m\^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.
CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m\^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
82.0%
41/50 • Number of events 134
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
2.0%
1/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
10.0%
5/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
54.0%
27/50 • Number of events 37
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Atrial fibrillation
|
6.0%
3/50 • Number of events 8
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Mitral valve disease
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Palpitations
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Sinus bradycardia
|
12.0%
6/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Ear and labyrinth disorders
Ear pain
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Endocrine disorders
Hypothyroidism
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Eye disorders
Blurred vision
|
8.0%
4/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Eye disorders
Conjunctivitis
|
4.0%
2/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Eye disorders
Dry eye
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Eye disorders
Eye disorders - Other
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Eye disorders
Vitreous hemorrhage
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
26.0%
13/50 • Number of events 18
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Anal ulcer
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Colitis
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
20/50 • Number of events 25
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Dental caries
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
35/50 • Number of events 81
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Dry mouth
|
8.0%
4/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
4/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Flatulence
|
8.0%
4/50 • Number of events 8
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
2/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
5/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.0%
6/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Mucositis oral
|
44.0%
22/50 • Number of events 31
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
30/50 • Number of events 58
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Oral pain
|
8.0%
4/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Rectal pain
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Stomach pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
12/50 • Number of events 18
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Chills
|
24.0%
12/50 • Number of events 14
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Edema face
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Edema limbs
|
44.0%
22/50 • Number of events 37
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Facial pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Fatigue
|
62.0%
31/50 • Number of events 77
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Fever
|
24.0%
12/50 • Number of events 14
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
General disorders and administration site conditions - Other
|
4.0%
2/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Infusion related reaction
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Malaise
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
General disorders
Pain
|
16.0%
8/50 • Number of events 11
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Bladder infection
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Bone infection
|
2.0%
1/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Catheter related infection
|
10.0%
5/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Infections and infestations - Other
|
16.0%
8/50 • Number of events 9
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Lip infection
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Lung infection
|
6.0%
3/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Sepsis
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Sinusitis
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Skin infection
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Small intestine infection
|
2.0%
1/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
5/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Injury, poisoning and procedural complications
Bruising
|
14.0%
7/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
14.0%
7/50 • Number of events 10
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Alanine aminotransferase increased
|
52.0%
26/50 • Number of events 66
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Alkaline phosphatase increased
|
34.0%
17/50 • Number of events 28
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Aspartate aminotransferase increased
|
46.0%
23/50 • Number of events 52
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Blood bilirubin increased
|
50.0%
25/50 • Number of events 49
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Cholesterol high
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Creatinine increased
|
18.0%
9/50 • Number of events 19
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
INR increased
|
22.0%
11/50 • Number of events 22
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Investigations - Other
|
4.0%
2/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Lipase increased
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Lymphocyte count decreased
|
42.0%
21/50 • Number of events 68
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Neutrophil count decreased
|
84.0%
42/50 • Number of events 97
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Platelet count decreased
|
84.0%
42/50 • Number of events 133
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Serum amylase increased
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
Weight loss
|
14.0%
7/50 • Number of events 11
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Investigations
White blood cell decreased
|
60.0%
30/50 • Number of events 71
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Anorexia
|
44.0%
22/50 • Number of events 38
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.0%
3/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.0%
4/50 • Number of events 8
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
54.0%
27/50 • Number of events 69
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
5/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.0%
6/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
68.0%
34/50 • Number of events 67
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
48.0%
24/50 • Number of events 36
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
48.0%
24/50 • Number of events 37
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
24.0%
12/50 • Number of events 20
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
48.0%
24/50 • Number of events 40
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
44.0%
22/50 • Number of events 31
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
6.0%
3/50 • Number of events 7
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
5/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
5/50 • Number of events 15
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.0%
7/50 • Number of events 8
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
6.0%
3/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
5/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
2.0%
1/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Dizziness
|
24.0%
12/50 • Number of events 15
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Dysgeusia
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Headache
|
32.0%
16/50 • Number of events 20
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Lethargy
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Nervous system disorders - Other
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Neuralgia
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.0%
3/50 • Number of events 12
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Phantom pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Sinus pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Transient ischemic attacks
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Nervous system disorders
Tremor
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Anxiety
|
18.0%
9/50 • Number of events 10
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Confusion
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Depression
|
12.0%
6/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Hallucinations
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Insomnia
|
18.0%
9/50 • Number of events 14
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Psychiatric disorders
Personality change
|
2.0%
1/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Hematuria
|
8.0%
4/50 • Number of events 9
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Proteinuria
|
6.0%
3/50 • Number of events 8
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
6.0%
3/50 • Number of events 10
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
5/50 • Number of events 9
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.0%
13/50 • Number of events 21
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.0%
18/50 • Number of events 25
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
24.0%
12/50 • Number of events 14
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
5/50 • Number of events 6
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
8.0%
4/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
6.0%
3/50 • Number of events 9
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.0%
8/50 • Number of events 12
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
6.0%
3/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.0%
8/50 • Number of events 19
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.0%
4/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.0%
3/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.0%
2/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
18.0%
9/50 • Number of events 18
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.0%
8/50 • Number of events 10
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.0%
3/50 • Number of events 3
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.0%
1/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
60.0%
30/50 • Number of events 63
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
22.0%
11/50 • Number of events 26
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.0%
2/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Flushing
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Hematoma
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Hot flashes
|
4.0%
2/50 • Number of events 5
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Hypertension
|
34.0%
17/50 • Number of events 30
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Hypotension
|
22.0%
11/50 • Number of events 13
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Phlebitis
|
2.0%
1/50 • Number of events 1
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/50 • Number of events 2
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
|
Vascular disorders
Vascular disorders - Other
|
2.0%
1/50 • Number of events 4
At the time of analysis, adverse event data was collected on 50 of 54 participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60