Trial Outcomes & Findings for Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT01238211)
NCT ID: NCT01238211
Last Updated: 2023-03-01
Results Overview
Percentage of participants who were alive 30 days after starting induction treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
30 days
Results posted on
2023-03-01
Participant Flow
Between April 2011 and January 2013, 61 participants were recruited.
Participant milestones
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
58
|
Reasons for withdrawal
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Overall Study
Continues active treatment
|
31
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
4
|
|
Overall Study
Relapse/Progression
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Non-protocol treatment
|
4
|
|
Overall Study
Investigator/Patient Decision
|
3
|
Baseline Characteristics
Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 Participants
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPercentage of participants who were alive 30 days after starting induction treatment.
Outcome measures
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 Participants
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
30 Day Survival Rate
|
97 percentage of participants
Interval 89.0 to 99.6
|
SECONDARY outcome
Timeframe: 1 yearEvent free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The 1 year EFS rate with 95% CI was estimated using the Kaplan-Meier method, Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts).
Outcome measures
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 Participants
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Event-free Survival
|
83 percentage of patients
Interval 70.7 to 90.5
|
SECONDARY outcome
Timeframe: 60 monthsPercentage of participants who achieve a CR. Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts).
Outcome measures
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 Participants
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Complete Response Rate
|
90 percentage of patients
Interval 80.0 to 96.0
|
SECONDARY outcome
Timeframe: 60 monthsOutcome measures
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 Participants
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Cumulative Incidence of Relapse
|
10 Participants
|
SECONDARY outcome
Timeframe: 36 monthsOutcome measures
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 Participants
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Cumulative Incidence of Death
|
15 Participants
|
SECONDARY outcome
Timeframe: 3 yearsDisease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The 3 year DFS rate with 95% CI was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 Participants
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Disease-free Survival
|
75 percentage of patients
Interval 63.0 to 89.0
|
SECONDARY outcome
Timeframe: 3 yearsOverall survival (OS) is defined as time from registration to death. The 3 year OS rate with 95% CI was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 Participants
INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m\^2)on days 1-3, cytarabine IV (200 mg/m\^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.
CONSOLIDATION THERAPY: high-dose cytarabine IV (patients \< Age 60: 3000 mg/m\^2, Age \>= 1000 mg/m\^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Overall Survival
|
77 percentage of patients
Interval 66.0 to 89.0
|
Adverse Events
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
Serious events: 27 serious events
Other events: 61 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 participants at risk
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.3%
2/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.1%
8/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
6.6%
4/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.6%
1/61 • 3 years
|
|
Vascular disorders
Flushing
|
1.6%
1/61 • 3 years
|
|
Vascular disorders
Hypertension
|
8.2%
5/61 • 3 years
|
|
Vascular disorders
Hypotension
|
14.8%
9/61 • 3 years
|
|
Vascular disorders
Peripheral ischemia
|
1.6%
1/61 • 3 years
|
|
Vascular disorders
Vascular disorders - Other
|
1.6%
1/61 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
42.6%
26/61 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
3.3%
2/61 • 3 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.6%
1/61 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
29.5%
18/61 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
2/61 • 3 years
|
|
Cardiac disorders
Atrial flutter
|
1.6%
1/61 • 3 years
|
|
Cardiac disorders
Cardiac arrest
|
1.6%
1/61 • 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
2/61 • 3 years
|
|
Cardiac disorders
Palpitations
|
1.6%
1/61 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
18.0%
11/61 • 3 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.6%
1/61 • 3 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.6%
1/61 • 3 years
|
|
Cardiac disorders
Ventricular tachycardia
|
3.3%
2/61 • 3 years
|
|
Endocrine disorders
Hyperthyroidism
|
1.6%
1/61 • 3 years
|
|
Eye disorders
Blurred vision
|
1.6%
1/61 • 3 years
|
|
Eye disorders
Conjunctivitis
|
1.6%
1/61 • 3 years
|
|
Eye disorders
Dry eye
|
1.6%
1/61 • 3 years
|
|
Eye disorders
Eye disorders - Other
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.6%
4/61 • 3 years
|
|
Gastrointestinal disorders
Ascites
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
9.8%
6/61 • 3 years
|
|
Gastrointestinal disorders
Dental caries
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
21.3%
13/61 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.9%
3/61 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.6%
4/61 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
32.8%
20/61 • 3 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Typhlitis
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
21.3%
13/61 • 3 years
|
|
General disorders
Chills
|
8.2%
5/61 • 3 years
|
|
General disorders
Edema face
|
1.6%
1/61 • 3 years
|
|
General disorders
Edema limbs
|
8.2%
5/61 • 3 years
|
|
General disorders
Edema trunk
|
3.3%
2/61 • 3 years
|
|
General disorders
Fatigue
|
36.1%
22/61 • 3 years
|
|
General disorders
Fever
|
14.8%
9/61 • 3 years
|
|
General disorders
General disorders and administration site conditions - Other
|
8.2%
5/61 • 3 years
|
|
General disorders
Infusion related reaction
|
1.6%
1/61 • 3 years
|
|
General disorders
Malaise
|
4.9%
3/61 • 3 years
|
|
General disorders
Multi-organ failure
|
1.6%
1/61 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/61 • 3 years
|
|
General disorders
Pain
|
8.2%
5/61 • 3 years
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Catheter related infection
|
3.3%
2/61 • 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Infections and infestations - Other
|
4.9%
3/61 • 3 years
|
|
Infections and infestations
Lung infection
|
13.1%
8/61 • 3 years
|
|
Infections and infestations
Mucosal infection
|
3.3%
2/61 • 3 years
|
|
Infections and infestations
Sepsis
|
9.8%
6/61 • 3 years
|
|
Infections and infestations
Sinusitis
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Skin infection
|
3.3%
2/61 • 3 years
|
|
Infections and infestations
Small intestine infection
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/61 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
3.3%
2/61 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/61 • 3 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
14.8%
9/61 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
24.6%
15/61 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
14.8%
9/61 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
27.9%
17/61 • 3 years
|
|
Investigations
Blood bilirubin increased
|
16.4%
10/61 • 3 years
|
|
Investigations
Cardiac troponin I increased
|
1.6%
1/61 • 3 years
|
|
Investigations
Creatinine increased
|
18.0%
11/61 • 3 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
9.8%
6/61 • 3 years
|
|
Investigations
Hemoglobin increased
|
1.6%
1/61 • 3 years
|
|
Investigations
INR increased
|
14.8%
9/61 • 3 years
|
|
Investigations
Investigations - Other
|
4.9%
3/61 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
29.5%
18/61 • 3 years
|
|
Investigations
Lymphocyte count increased
|
3.3%
2/61 • 3 years
|
|
Investigations
Neutrophil count decreased
|
42.6%
26/61 • 3 years
|
|
Investigations
Platelet count decreased
|
44.3%
27/61 • 3 years
|
|
Investigations
Weight gain
|
1.6%
1/61 • 3 years
|
|
Investigations
Weight loss
|
9.8%
6/61 • 3 years
|
|
Investigations
White blood cell decreased
|
29.5%
18/61 • 3 years
|
|
Metabolism and nutrition disorders
Acidosis
|
6.6%
4/61 • 3 years
|
|
Metabolism and nutrition disorders
Alkalosis
|
3.3%
2/61 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
18.0%
11/61 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
3/61 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
31.1%
19/61 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.5%
7/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.9%
3/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.6%
4/61 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
9.8%
6/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
34.4%
21/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.7%
12/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.9%
3/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.2%
16/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.8%
6/61 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.3%
13/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.8%
6/61 • 3 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
3.3%
2/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
3/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.6%
4/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
3.3%
2/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
2/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
1/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
2/61 • 3 years
|
|
Nervous system disorders
Ataxia
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Dizziness
|
8.2%
5/61 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
3.3%
2/61 • 3 years
|
|
Nervous system disorders
Headache
|
19.7%
12/61 • 3 years
|
|
Nervous system disorders
Hydrocephalus
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Lethargy
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Nervous system disorders - Other
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Paresthesia
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.9%
3/61 • 3 years
|
|
Nervous system disorders
Sinus pain
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Somnolence
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Syncope
|
3.3%
2/61 • 3 years
|
|
Nervous system disorders
Tremor
|
1.6%
1/61 • 3 years
|
|
Psychiatric disorders
Agitation
|
1.6%
1/61 • 3 years
|
|
Psychiatric disorders
Anxiety
|
8.2%
5/61 • 3 years
|
|
Psychiatric disorders
Confusion
|
1.6%
1/61 • 3 years
|
|
Psychiatric disorders
Delirium
|
1.6%
1/61 • 3 years
|
|
Psychiatric disorders
Depression
|
4.9%
3/61 • 3 years
|
|
Psychiatric disorders
Insomnia
|
4.9%
3/61 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
11.5%
7/61 • 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.3%
2/61 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
6.6%
4/61 • 3 years
|
|
Renal and urinary disorders
Proteinuria
|
11.5%
7/61 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
1.6%
1/61 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
1/61 • 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
1.6%
1/61 • 3 years
|
|
Reproductive system and breast disorders
Genital edema
|
1.6%
1/61 • 3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.6%
1/61 • 3 years
|
|
Reproductive system and breast disorders
Perineal pain
|
1.6%
1/61 • 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
7/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.0%
11/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.9%
3/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.6%
4/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
2/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.2%
5/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
4.9%
3/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.9%
3/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.6%
1/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.9%
3/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
2/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.6%
1/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
1.6%
1/61 • 3 years
|
Other adverse events
| Measure |
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
n=61 participants at risk
CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
95.1%
58/61 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
8.2%
5/61 • 3 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
13.1%
8/61 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
77.0%
47/61 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.8%
6/61 • 3 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.9%
3/61 • 3 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
3.3%
2/61 • 3 years
|
|
Cardiac disorders
Cardiac disorders - Other
|
8.2%
5/61 • 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
2/61 • 3 years
|
|
Cardiac disorders
Heart failure
|
4.9%
3/61 • 3 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
4.9%
3/61 • 3 years
|
|
Cardiac disorders
Mitral valve disease
|
1.6%
1/61 • 3 years
|
|
Cardiac disorders
Palpitations
|
8.2%
5/61 • 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
4.9%
3/61 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
26.2%
16/61 • 3 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.3%
2/61 • 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
1.6%
1/61 • 3 years
|
|
Endocrine disorders
Hypothyroidism
|
1.6%
1/61 • 3 years
|
|
Eye disorders
Blurred vision
|
9.8%
6/61 • 3 years
|
|
Eye disorders
Conjunctivitis
|
4.9%
3/61 • 3 years
|
|
Eye disorders
Eye disorders - Other
|
4.9%
3/61 • 3 years
|
|
Eye disorders
Eye pain
|
3.3%
2/61 • 3 years
|
|
Eye disorders
Floaters
|
1.6%
1/61 • 3 years
|
|
Eye disorders
Keratitis
|
3.3%
2/61 • 3 years
|
|
Eye disorders
Photophobia
|
3.3%
2/61 • 3 years
|
|
Eye disorders
Retinal vascular disorder
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
19.7%
12/61 • 3 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Anal pain
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Ascites
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
49.2%
30/61 • 3 years
|
|
Gastrointestinal disorders
Dental caries
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
72.1%
44/61 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
3/61 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
8.2%
5/61 • 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
6.6%
4/61 • 3 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.8%
9/61 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
13.1%
8/61 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Gingival pain
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
39.3%
24/61 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
77.0%
47/61 • 3 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
13.1%
8/61 • 3 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
6.6%
4/61 • 3 years
|
|
Gastrointestinal disorders
Rectal ulcer
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Tooth discoloration
|
1.6%
1/61 • 3 years
|
|
Gastrointestinal disorders
Toothache
|
4.9%
3/61 • 3 years
|
|
Gastrointestinal disorders
Typhlitis
|
3.3%
2/61 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
60.7%
37/61 • 3 years
|
|
General disorders
Chills
|
19.7%
12/61 • 3 years
|
|
General disorders
Edema face
|
4.9%
3/61 • 3 years
|
|
General disorders
Edema limbs
|
31.1%
19/61 • 3 years
|
|
General disorders
Edema trunk
|
1.6%
1/61 • 3 years
|
|
General disorders
Facial pain
|
1.6%
1/61 • 3 years
|
|
General disorders
Fatigue
|
77.0%
47/61 • 3 years
|
|
General disorders
Fever
|
42.6%
26/61 • 3 years
|
|
General disorders
General disorders and administration site conditions - Other
|
16.4%
10/61 • 3 years
|
|
General disorders
Infusion related reaction
|
6.6%
4/61 • 3 years
|
|
General disorders
Injection site reaction
|
1.6%
1/61 • 3 years
|
|
General disorders
Localized edema
|
4.9%
3/61 • 3 years
|
|
General disorders
Malaise
|
4.9%
3/61 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
11.5%
7/61 • 3 years
|
|
General disorders
Pain
|
8.2%
5/61 • 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Anorectal infection
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Catheter related infection
|
4.9%
3/61 • 3 years
|
|
Infections and infestations
Device related infection
|
6.6%
4/61 • 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Infections and infestations - Other
|
23.0%
14/61 • 3 years
|
|
Infections and infestations
Lip infection
|
3.3%
2/61 • 3 years
|
|
Infections and infestations
Lung infection
|
19.7%
12/61 • 3 years
|
|
Infections and infestations
Lymph gland infection
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Mucosal infection
|
3.3%
2/61 • 3 years
|
|
Infections and infestations
Paronychia
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Sepsis
|
4.9%
3/61 • 3 years
|
|
Infections and infestations
Sinusitis
|
4.9%
3/61 • 3 years
|
|
Infections and infestations
Skin infection
|
9.8%
6/61 • 3 years
|
|
Infections and infestations
Soft tissue infection
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Tooth infection
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
4.9%
3/61 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
4.9%
3/61 • 3 years
|
|
Infections and infestations
Vaginal infection
|
3.3%
2/61 • 3 years
|
|
Infections and infestations
Vulval infection
|
1.6%
1/61 • 3 years
|
|
Infections and infestations
Wound infection
|
1.6%
1/61 • 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
16.4%
10/61 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
3/61 • 3 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
1.6%
1/61 • 3 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
1.6%
1/61 • 3 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
29.5%
18/61 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
67.2%
41/61 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
34.4%
21/61 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
49.2%
30/61 • 3 years
|
|
Investigations
Blood bilirubin increased
|
31.1%
19/61 • 3 years
|
|
Investigations
Cardiac troponin I increased
|
1.6%
1/61 • 3 years
|
|
Investigations
Cholesterol high
|
1.6%
1/61 • 3 years
|
|
Investigations
Creatinine increased
|
16.4%
10/61 • 3 years
|
|
Investigations
Ejection fraction decreased
|
1.6%
1/61 • 3 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
24.6%
15/61 • 3 years
|
|
Investigations
Fibrinogen decreased
|
3.3%
2/61 • 3 years
|
|
Investigations
INR increased
|
36.1%
22/61 • 3 years
|
|
Investigations
Investigations - Other
|
1.6%
1/61 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
52.5%
32/61 • 3 years
|
|
Investigations
Lymphocyte count increased
|
13.1%
8/61 • 3 years
|
|
Investigations
Neutrophil count decreased
|
83.6%
51/61 • 3 years
|
|
Investigations
Platelet count decreased
|
83.6%
51/61 • 3 years
|
|
Investigations
Weight gain
|
4.9%
3/61 • 3 years
|
|
Investigations
Weight loss
|
19.7%
12/61 • 3 years
|
|
Investigations
White blood cell decreased
|
65.6%
40/61 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
44.3%
27/61 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.2%
5/61 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
65.6%
40/61 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.4%
10/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.5%
7/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.2%
5/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.6%
1/61 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
23.0%
14/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
62.3%
38/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
59.0%
36/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.1%
8/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
49.2%
30/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.0%
14/61 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
49.2%
30/61 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
32.8%
20/61 • 3 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
6.6%
4/61 • 3 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.6%
1/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Abdominal soft tissue necrosis
|
1.6%
1/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
6/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.9%
3/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
1.6%
1/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.6%
15/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.2%
5/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
4.9%
3/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.3%
2/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.4%
10/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.6%
1/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
8.2%
5/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.4%
10/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.6%
4/61 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.1%
8/61 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Akathisia
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Amnesia
|
3.3%
2/61 • 3 years
|
|
Nervous system disorders
Ataxia
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Concentration impairment
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Dizziness
|
24.6%
15/61 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
8.2%
5/61 • 3 years
|
|
Nervous system disorders
Headache
|
50.8%
31/61 • 3 years
|
|
Nervous system disorders
Lethargy
|
3.3%
2/61 • 3 years
|
|
Nervous system disorders
Memory impairment
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Nervous system disorders - Other
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.6%
1/61 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.6%
4/61 • 3 years
|
|
Nervous system disorders
Tremor
|
1.6%
1/61 • 3 years
|
|
Psychiatric disorders
Anxiety
|
21.3%
13/61 • 3 years
|
|
Psychiatric disorders
Confusion
|
1.6%
1/61 • 3 years
|
|
Psychiatric disorders
Delirium
|
1.6%
1/61 • 3 years
|
|
Psychiatric disorders
Depression
|
18.0%
11/61 • 3 years
|
|
Psychiatric disorders
Hallucinations
|
1.6%
1/61 • 3 years
|
|
Psychiatric disorders
Insomnia
|
24.6%
15/61 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/61 • 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
8.2%
5/61 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
6.6%
4/61 • 3 years
|
|
Renal and urinary disorders
Proteinuria
|
14.8%
9/61 • 3 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
1.6%
1/61 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
3.3%
2/61 • 3 years
|
|
Reproductive system and breast disorders
Breast pain
|
1.6%
1/61 • 3 years
|
|
Reproductive system and breast disorders
Genital edema
|
1.6%
1/61 • 3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
4.9%
3/61 • 3 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
4.9%
3/61 • 3 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.6%
1/61 • 3 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
3.3%
2/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.6%
4/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.9%
3/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
3.3%
2/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.1%
22/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.6%
26/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.1%
8/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.2%
5/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.8%
9/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.3%
2/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
21.3%
13/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.9%
3/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
2/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.9%
3/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
8.2%
5/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
1.6%
1/61 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.8%
6/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.1%
8/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.2%
5/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.9%
3/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
2/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.3%
2/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.6%
4/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
1.6%
1/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.6%
1/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.1%
8/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
8.2%
5/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.6%
1/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.8%
31/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.6%
1/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
29.5%
18/61 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.9%
3/61 • 3 years
|
|
Vascular disorders
Flushing
|
1.6%
1/61 • 3 years
|
|
Vascular disorders
Hematoma
|
8.2%
5/61 • 3 years
|
|
Vascular disorders
Hypertension
|
23.0%
14/61 • 3 years
|
|
Vascular disorders
Hypotension
|
23.0%
14/61 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
3.3%
2/61 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60