Trial Outcomes & Findings for Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT00658814)
NCT ID: NCT00658814
Last Updated: 2026-04-30
Results Overview
Morphologic complete remission (CR): ANC \>=1,000/mcL, platelet count \>=100,000/mcL, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcL and/or platelet count \<100,000/mcL.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
Up to 60 days
Results posted on
2026-04-30
Participant Flow
Participant milestones
| Measure |
Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Patients in continued remission may go on to receive maintenance therapy.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Patients in continued remission may go on to receive maintenance therapy.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
|---|---|---|
|
Remission Induction Chemotherapy
STARTED
|
83
|
59
|
|
Remission Induction Chemotherapy
Eligible
|
82
|
57
|
|
Remission Induction Chemotherapy
Eligible and Began Protocol Therapy
|
79
|
54
|
|
Remission Induction Chemotherapy
COMPLETED
|
75
|
41
|
|
Remission Induction Chemotherapy
NOT COMPLETED
|
8
|
18
|
|
Consolidation Therapy
STARTED
|
24
|
13
|
|
Consolidation Therapy
Eligible
|
22
|
11
|
|
Consolidation Therapy
COMPLETED
|
22
|
10
|
|
Consolidation Therapy
NOT COMPLETED
|
2
|
3
|
|
Maintenance Therapy
STARTED
|
20
|
8
|
|
Maintenance Therapy
Eligible
|
19
|
8
|
|
Maintenance Therapy
COMPLETED
|
17
|
7
|
|
Maintenance Therapy
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Patients in continued remission may go on to receive maintenance therapy.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Patients in continued remission may go on to receive maintenance therapy.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
|---|---|---|
|
Remission Induction Chemotherapy
Adverse Event
|
1
|
3
|
|
Remission Induction Chemotherapy
Withdrawal by Subject
|
3
|
4
|
|
Remission Induction Chemotherapy
Progression/Relapse
|
0
|
1
|
|
Remission Induction Chemotherapy
Death
|
1
|
4
|
|
Remission Induction Chemotherapy
Not protocol specified
|
2
|
4
|
|
Remission Induction Chemotherapy
Not eligible
|
1
|
2
|
|
Consolidation Therapy
Not protocol specified
|
0
|
1
|
|
Consolidation Therapy
Not eligible
|
2
|
2
|
|
Maintenance Therapy
Adverse Event
|
1
|
1
|
|
Maintenance Therapy
Not protocol specified
|
1
|
0
|
|
Maintenance Therapy
Not eligible
|
1
|
0
|
Baseline Characteristics
Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
n=79 Participants
Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin
n=54 Participants
Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.
Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.2 years
n=14 Participants
|
76 years
n=34 Participants
|
73.4 years
n=69 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=14 Participants
|
21 Participants
n=34 Participants
|
51 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=14 Participants
|
33 Participants
n=34 Participants
|
82 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=14 Participants
|
0 participants
n=34 Participants
|
1 participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=14 Participants
|
4 participants
n=34 Participants
|
5 participants
n=69 Participants
|
|
Race/Ethnicity, Customized
White
|
77 participants
n=14 Participants
|
50 participants
n=34 Participants
|
127 participants
n=69 Participants
|
|
Hispanic
Yes
|
3 participants
n=14 Participants
|
1 participants
n=34 Participants
|
4 participants
n=69 Participants
|
|
Hispanic
No
|
64 participants
n=14 Participants
|
50 participants
n=34 Participants
|
114 participants
n=69 Participants
|
|
Hispanic
Unknown
|
12 participants
n=14 Participants
|
3 participants
n=34 Participants
|
15 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: Up to 60 daysMorphologic complete remission (CR): ANC \>=1,000/mcL, platelet count \>=100,000/mcL, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcL and/or platelet count \<100,000/mcL.
Outcome measures
| Measure |
Remission Induction Chemotherapy
n=79 Participants
Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
|
Consolidation Therapy
n=54 Participants
Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
|
Maintenance Therapy
Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
|---|---|---|---|
|
Complete Response
|
44 percentage of participants
Interval 33.0 to 56.0
|
35 percentage of participants
Interval 23.0 to 49.0
|
—
|
PRIMARY outcome
Timeframe: 30 daysPatients surviving more than 30 days after study registration
Outcome measures
| Measure |
Remission Induction Chemotherapy
n=79 Participants
Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
|
Consolidation Therapy
n=54 Participants
Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
|
Maintenance Therapy
Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
|---|---|---|---|
|
30-Day Survival
|
92 percentage of participants
Interval 84.0 to 97.0
|
87 percentage of participants
Interval 75.0 to 95.0
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Remission Induction Chemotherapy
n=133 Participants
Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
|
Consolidation Therapy
n=32 Participants
Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
|
Maintenance Therapy
n=27 Participants
Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
|---|---|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Albumin, serum-low (hypoalbuminemia)
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Bilirubin (hyperbilirubinemia)
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Calcium, serum-low (hypocalcemia)
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Carbon monoxide diffusion capacity (DL(co))
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac Arrhythmia-Atrial fibrilation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac General-cardiopulmonary disease
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac General-Chest Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac troponin I (cTnI)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac-ischemia/infarction
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Conduction abnormality NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Confusion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Constipation
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cytokine release syndrome/acute infusion reaction
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Death - Disease progression NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Death - Multi-organ failure
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Death not associated with CTCAE term - Death NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dehydration
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
18 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
50 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
10 Participants
|
3 Participants
|
2 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
73 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage, CNS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage, GI - Stomach
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage, GI - Upper GI NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage/Bleeding-platelets and red blood cells
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hepatobiliary/Pancreas-venoocclusive disease
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypertension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypotension
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypoxia
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
16 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Kidney
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Blood
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Lung (pneumonia)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mood alteration - depression
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (functional/symp) - Oral cav
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Muscle weakness, not d/t neuropathy - body/general
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
85 Participants
|
21 Participants
|
10 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Cardiac/heart
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Petechiae/purpura (hemorrhage into skin or mucosa)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Platelets
|
85 Participants
|
12 Participants
|
3 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pleural effusion (non-malignant)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pulmonary/Upper Respiratory-pulmonary edema
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
SVT and nodal arrhythmia - Atrial fibrillation
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
SVT and nodal arrhythmia - SVT tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Sudden death
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Anorexia
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Edema: limb
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Phosphate, serum-low (hypophosphatemia)
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Adult respiratory distress syndrome (ARDS)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
ALT, SGPT (serum glutamic pyruvic transaminase)
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
AST, SGOT
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Skin (cellulitis)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection-Aspirgillosis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection-bacteremia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Left ventricular systolic dysfunction
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
80 Participants
|
18 Participants
|
6 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Liver dysfunction/failure (clinical)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
23 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsRelapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or \> 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.
Outcome measures
| Measure |
Remission Induction Chemotherapy
n=35 Participants
Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
|
Consolidation Therapy
n=19 Participants
Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
|
Maintenance Therapy
Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
|---|---|---|---|
|
Relapse-free Survival
|
8 months
Interval 5.0 to 13.0
|
7 months
Interval 6.0 to 12.0
|
—
|
Adverse Events
Remission Induction Chemotherapy
Serious events: 55 serious events
Other events: 130 other events
Deaths: 0 deaths
Consolidation Therapy
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Maintenance Therapy
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remission Induction Chemotherapy
n=133 participants at risk
Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
|
Consolidation Therapy
n=32 participants at risk
Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
|
Maintenance Therapy
n=27 participants at risk
Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
9.0%
12/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Nervous system disorders
Hemorrhage, CNS
|
2.3%
3/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Nervous system disorders
Neurology-Other
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Psychiatric disorders
Confusion
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Psychiatric disorders
Mood alteration - depression
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Renal and urinary disorders
Renal failure
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.8%
5/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
4/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify):Pulmonary Edema
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify):Respiratory distress
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
4.5%
6/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.3%
3/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Vascular disorders
Vascular-Other (Specify):pariatal to occiptal lobe
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.5%
10/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.0%
4/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Cardiac disorders
Conduction abnormality NOS
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Cardiac disorders
Pain - Cardiac/heart
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
2.3%
3/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - SVT tachycardia
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular fibrillation
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Gastrointestinal disorders
Colitis
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Stomach
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
General disorders
Death - Multi-organ failure
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
General disorders
Sudden death
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
0.00%
0/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
5.3%
7/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
|
0.75%
1/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
5.3%
7/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2.3%
3/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0.00%
0/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Infection-Other (Specify):bacteremia
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Hemorrhage/bleeding w/surgery, intra- or post-op
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
AST, SGOT
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
Carbon monoxide diffusion capacity (DL(co))
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
Cardiac troponin I (cTnI)
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
Creatinine
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
Leukocytes (total WBC)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.3%
3/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Investigations
Platelets
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.75%
1/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
Other adverse events
| Measure |
Remission Induction Chemotherapy
n=133 participants at risk
Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
|
Consolidation Therapy
n=32 participants at risk
Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
|
Maintenance Therapy
n=27 participants at risk
Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
47.4%
63/133 • Up to 5 years
|
40.6%
13/32 • Up to 5 years
|
33.3%
9/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.8%
45/133 • Up to 5 years
|
15.6%
5/32 • Up to 5 years
|
18.5%
5/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
2.3%
3/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
36.8%
49/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
73.7%
98/133 • Up to 5 years
|
62.5%
20/32 • Up to 5 years
|
55.6%
15/27 • Up to 5 years
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
0.00%
0/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
35.3%
47/133 • Up to 5 years
|
18.8%
6/32 • Up to 5 years
|
37.0%
10/27 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
26.3%
35/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
25.9%
7/27 • Up to 5 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
6.0%
8/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.0%
8/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
9.0%
12/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
6.0%
8/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
42.1%
56/133 • Up to 5 years
|
15.6%
5/32 • Up to 5 years
|
18.5%
5/27 • Up to 5 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
10.5%
14/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
20.3%
27/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
General disorders
Edema: limb
|
22.6%
30/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
60.9%
81/133 • Up to 5 years
|
46.9%
15/32 • Up to 5 years
|
40.7%
11/27 • Up to 5 years
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
10.5%
14/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
General disorders
Injection site reaction/extravasation changes
|
6.8%
9/133 • Up to 5 years
|
15.6%
5/32 • Up to 5 years
|
33.3%
9/27 • Up to 5 years
|
|
General disorders
Pain - Chest/thorax NOS
|
5.3%
7/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
General disorders
Rigors/chills
|
15.8%
21/133 • Up to 5 years
|
6.2%
2/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
11.3%
15/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
6.8%
9/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
0.75%
1/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
22.6%
30/133 • Up to 5 years
|
15.6%
5/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Investigations
AST, SGOT
|
26.3%
35/133 • Up to 5 years
|
31.2%
10/32 • Up to 5 years
|
22.2%
6/27 • Up to 5 years
|
|
Investigations
Alkaline phosphatase
|
16.5%
22/133 • Up to 5 years
|
12.5%
4/32 • Up to 5 years
|
14.8%
4/27 • Up to 5 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
13.5%
18/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
18.5%
5/27 • Up to 5 years
|
|
Investigations
Creatinine
|
23.3%
31/133 • Up to 5 years
|
18.8%
6/32 • Up to 5 years
|
25.9%
7/27 • Up to 5 years
|
|
Investigations
Leukocytes (total WBC)
|
65.4%
87/133 • Up to 5 years
|
71.9%
23/32 • Up to 5 years
|
59.3%
16/27 • Up to 5 years
|
|
Investigations
Lymphopenia
|
30.1%
40/133 • Up to 5 years
|
12.5%
4/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
68.4%
91/133 • Up to 5 years
|
71.9%
23/32 • Up to 5 years
|
51.9%
14/27 • Up to 5 years
|
|
Investigations
Platelets
|
75.2%
100/133 • Up to 5 years
|
78.1%
25/32 • Up to 5 years
|
40.7%
11/27 • Up to 5 years
|
|
Investigations
Weight loss
|
9.8%
13/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
51.9%
69/133 • Up to 5 years
|
56.2%
18/32 • Up to 5 years
|
70.4%
19/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.3%
7/133 • Up to 5 years
|
6.2%
2/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
33.8%
45/133 • Up to 5 years
|
12.5%
4/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - Extrem-lower
|
1.5%
2/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
15.0%
20/133 • Up to 5 years
|
6.2%
2/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
4.5%
6/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
14.8%
4/27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
6.0%
8/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
18.5%
5/27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
4.5%
6/133 • Up to 5 years
|
6.2%
2/32 • Up to 5 years
|
14.8%
4/27 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
12.0%
16/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
14.8%
4/27 • Up to 5 years
|
|
Nervous system disorders
Neuropathy: sensory
|
1.5%
2/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Nervous system disorders
Pain - Head/headache
|
10.5%
14/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
6.8%
9/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Psychiatric disorders
Confusion
|
6.8%
9/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
12.0%
16/133 • Up to 5 years
|
15.6%
5/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
8.3%
11/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
6.8%
9/133 • Up to 5 years
|
12.5%
4/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
14.3%
19/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Psychiatric disorders
Mood alteration - anxiety
|
9.0%
12/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.3%
7/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
24.8%
33/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Psychiatric disorders
Mood alteration - depression
|
9.0%
12/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Renal and urinary disorders
Glomerular filtration rate
|
4.5%
6/133 • Up to 5 years
|
6.2%
2/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
43.6%
58/133 • Up to 5 years
|
18.8%
6/32 • Up to 5 years
|
18.5%
5/27 • Up to 5 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.0%
8/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.5%
26/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
24.8%
33/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
9.0%
12/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.5%
10/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
6.8%
9/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
0.75%
1/133 • Up to 5 years
|
6.2%
2/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage into skin or mucosa)
|
12.0%
16/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
0.00%
0/27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.0%
8/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
21.8%
29/133 • Up to 5 years
|
9.4%
3/32 • Up to 5 years
|
11.1%
3/27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
0.00%
0/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
9.0%
12/133 • Up to 5 years
|
6.2%
2/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
8.3%
11/133 • Up to 5 years
|
0.00%
0/32 • Up to 5 years
|
3.7%
1/27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - elevated blood urea nitrogen
|
8.3%
11/133 • Up to 5 years
|
3.1%
1/32 • Up to 5 years
|
7.4%
2/27 • Up to 5 years
|
Additional Information
Study Statistician
SWOG
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60