Trial Outcomes & Findings for S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia (NCT NCT00492856)
NCT ID: NCT00492856
Last Updated: 2023-01-10
Results Overview
DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient \> 10\^-5 based on RT-PCR performed at appropriate central lab.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
105 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
Low and Intermediate Risk APL Patients
All patients received induction: ATRA 45 mg/m\^2/day orally, divided BID, Ara-C 200 mg/m\^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m\^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m\^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m\^2/day IV bolus days 1-3 (2 courses).
|
Post-consolidation ATRA, 6-MP, MTX
Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m\^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m\^2/day orally daily, Methotrexate 20 mg/m\^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
|
Post-consolidation Observation
Patients who achieved CRm after consolidation and were randomized to the observation arm.
|
Post-consolidation Gemtuzumab Ozogamicin
Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m\^2/day IV over 2 hours days 1 and 15 (up to 6 does).
|
|---|---|---|---|---|
|
Induction
STARTED
|
105
|
0
|
0
|
0
|
|
Induction
COMPLETED
|
99
|
0
|
0
|
0
|
|
Induction
NOT COMPLETED
|
6
|
0
|
0
|
0
|
|
Consolidation
STARTED
|
92
|
0
|
0
|
0
|
|
Consolidation
COMPLETED
|
83
|
0
|
0
|
0
|
|
Consolidation
NOT COMPLETED
|
9
|
0
|
0
|
0
|
|
Post-consolidation
STARTED
|
0
|
41
|
27
|
1
|
|
Post-consolidation
COMPLETED
|
0
|
29
|
0
|
0
|
|
Post-consolidation
NOT COMPLETED
|
0
|
12
|
27
|
1
|
Reasons for withdrawal
| Measure |
Low and Intermediate Risk APL Patients
All patients received induction: ATRA 45 mg/m\^2/day orally, divided BID, Ara-C 200 mg/m\^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m\^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m\^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m\^2/day IV bolus days 1-3 (2 courses).
|
Post-consolidation ATRA, 6-MP, MTX
Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m\^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m\^2/day orally daily, Methotrexate 20 mg/m\^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
|
Post-consolidation Observation
Patients who achieved CRm after consolidation and were randomized to the observation arm.
|
Post-consolidation Gemtuzumab Ozogamicin
Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m\^2/day IV over 2 hours days 1 and 15 (up to 6 does).
|
|---|---|---|---|---|
|
Induction
Adverse Event
|
2
|
0
|
0
|
0
|
|
Induction
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Induction
Death
|
3
|
0
|
0
|
0
|
|
Consolidation
Adverse Event
|
6
|
0
|
0
|
0
|
|
Consolidation
Not protocol specified
|
2
|
0
|
0
|
0
|
|
Consolidation
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Post-consolidation
Adverse Event
|
0
|
4
|
0
|
1
|
|
Post-consolidation
Withdrawal by Subject
|
0
|
4
|
0
|
0
|
|
Post-consolidation
Death
|
0
|
1
|
0
|
0
|
|
Post-consolidation
Not protocol specified
|
0
|
1
|
0
|
0
|
|
Post-consolidation
Lost to Follow-up
|
0
|
2
|
0
|
0
|
|
Post-consolidation
Observation Arm
|
0
|
0
|
27
|
0
|
Baseline Characteristics
S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
Baseline characteristics by cohort
| Measure |
Low and Intermediate Risk APL Patients
n=105 Participants
All patients received induction: ATRA 45 mg/m\^2/day orally, divided BID, Ara-C 200 mg/m\^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m\^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m\^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m\^2/day IV bolus days 1-3 (2 courses). If CRm, patients randomized to either (1) maintenance: ATRA 45 mg/m\^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m\^2/day orally daily, Methotrexate 20 mg/m\^2 orally once a week (1 year cycle), or (2) observation. If CR or CRi, but not CRm, patients received maintenance gemtuzumab ozogamicin 6 mg/m\^2/day IV over 2 hours days 1 and 15 (up to 6 does). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
|
|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 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
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Eligible patients in molecular remission after receiving consolidation and randomized to either maintenance chemotherapy or observation. As of 8/15/10, all eligible patients were non-randomly assigned to receive maintenance chemotherapy. Only those that were randomized to either maintenance treatment or observation were included.
DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient \> 10\^-5 based on RT-PCR performed at appropriate central lab.
Outcome measures
| Measure |
ATRA + Ara-C + Daunorubicin
n=28 Participants
ATRA 45 mg/m\^2/day orally, divided BID, Ara-C 200 mg/m\^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m\^2/day IV bolus days 3-6
|
Consolidation
n=27 Participants
Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m\^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m\^2/day IV bolus days 1-3 (2 courses).
|
ATRA+6-MP+MTX
ATRA 45 mg/m\^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m\^2/day orally daily, Methotrexate 20 mg/m\^2 orally once a week (1 year cycle).
|
Gemtuzumab Ozogamicin
Gemtuzumab Ozogamicin 6 mg/m\^2/day IV over 2 hours days 1 and 15 (up to 6 does)
|
|---|---|---|---|---|
|
3-year Disease-free Survival (DFS) Rate
|
96 percentage of patients
Interval 90.0 to 100.0
|
100 percentage of patients
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible patients who received any treatment and were assessed for adverse events 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 |
ATRA + Ara-C + Daunorubicin
n=105 Participants
ATRA 45 mg/m\^2/day orally, divided BID, Ara-C 200 mg/m\^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m\^2/day IV bolus days 3-6
|
Consolidation
n=90 Participants
Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m\^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m\^2/day IV bolus days 1-3 (2 courses).
|
ATRA+6-MP+MTX
n=38 Participants
ATRA 45 mg/m\^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m\^2/day orally daily, Methotrexate 20 mg/m\^2 orally once a week (1 year cycle).
|
Gemtuzumab Ozogamicin
n=1 Participants
Gemtuzumab Ozogamicin 6 mg/m\^2/day IV over 2 hours days 1 and 15 (up to 6 does)
|
|---|---|---|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Scrotum
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pericardial effusion (non-malignant)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
AST, SGOT
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Albumin, serum-low (hypoalbuminemia)
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Alkaline phosphatase
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Alkalosis (metabolic or respiratory)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dry skin
|
1 Participants
|
0 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)
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Enteritis (inflammation of the small bowel)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 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
|
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 - Cecum
|
1 Participants
|
0 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 - Colon
|
4 Participants
|
0 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 - Dental-tooth
|
1 Participants
|
0 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)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mood alteration - anxiety
|
0 Participants
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Abdomen NOS
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Back
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Extremity-limb
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Muscle
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Neck
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Vasovagal episode
|
1 Participants
|
1 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)
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac Arrhythmia-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cardiac troponin T (cTnT)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Cholesterol, serum-high (hypercholesterolemia)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Coagulation-Other (Specify)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Confusion
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Creatinine
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
DIC (disseminated intravascular coagulation)
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dehydration
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Distention/bloating, abdominal
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dizziness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dysphagia (difficulty swallowing)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Extremity-lower (gait/walking)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
8 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
58 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Flu-like syndrome
|
0 Participants
|
1 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)
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
37 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage, GI - Rectum
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage, GU - Vagina
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage, pulmonary/upper respiratory - Lung
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage, pulmonary/upper respiratory - Nose
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Ventricular arrhythmia - Ventricular tachycardia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypertension
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypotension
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypoxia
|
6 Participants
|
0 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
|
10 Participants
|
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
|
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 - Oral cav-gums
|
1 Participants
|
0 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
|
0 Participants
|
0 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 - Skin
|
3 Participants
|
0 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
|
1 Participants
|
0 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 - Up aerodigest
|
1 Participants
|
0 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 - Bladder
|
0 Participants
|
0 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 - Blood
|
1 Participants
|
5 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 - Catheter
|
0 Participants
|
1 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 - Gallbladd
|
1 Participants
|
0 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 - Skin
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/unknown ANC - Oral cavity-gums (gingivitis)
|
1 Participants
|
0 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 - Bladder (urinary)
|
1 Participants
|
0 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
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Rectum
|
1 Participants
|
0 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
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Infection-Other (Specify)
|
2 Participants
|
0 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
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
34 Participants
|
37 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
20 Participants
|
20 Participants
|
7 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Metabolic/Laboratory-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mood alteration - agitation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Oral cavity
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Rectum
|
1 Participants
|
0 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
|
0 Participants
|
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 - Extrem-lower
|
1 Participants
|
0 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 - Extrem-upper
|
1 Participants
|
0 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
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Myositis (inflammation/damage of muscle)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Nausea
|
6 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
0 Participants
|
2 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)
|
34 Participants
|
55 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Chest/thorax NOS
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Head/headache
|
10 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Joint
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Rectum
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Throat/pharynx/larynx
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pericarditis
|
0 Participants
|
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)
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Photosensitivity
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Platelets
|
42 Participants
|
18 Participants
|
2 Participants
|
0 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
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Prolonged QTc interval
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pruritus/itching
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Renal failure
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Renal/Genitourinary-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Restrictive cardiomyopathy
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Retinal detachment
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Retinoic acid syndrome
|
13 Participants
|
0 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)
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Syncope (fainting)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Triglyceride, serum-high (hypertriglyceridemia)
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Typhlitis (cecal inflammation)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Uric acid, serum-high (hyperuricemia)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Vomiting
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Weight gain
|
1 Participants
|
0 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
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Acidosis (metabolic or respiratory)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Anorexia
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Bilirubin (hyperbilirubinemia)
|
7 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
CPK (creatine phosphokinase)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
ATRA + Ara-C + Daunorubicin
Serious events: 8 serious events
Other events: 105 other events
Deaths: 0 deaths
Consolidation
Serious events: 4 serious events
Other events: 89 other events
Deaths: 0 deaths
ATRA+6-MP+MTX
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Gemtuzumab Ozogamicin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATRA + Ara-C + Daunorubicin
n=105 participants at risk
ATRA 45 mg/m\^2/day orally, divided BID, Ara-C 200 mg/m\^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m\^2/day IV bolus days 3-6
|
Consolidation
n=90 participants at risk
Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m\^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m\^2/day IV bolus days 1-3 (2 courses).
|
ATRA+6-MP+MTX
n=38 participants at risk
ATRA 45 mg/m\^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m\^2/day orally daily, Methotrexate 20 mg/m\^2 orally once a week (1 year cycle).
|
Gemtuzumab Ozogamicin
n=1 participants at risk
Gemtuzumab Ozogamicin 6 mg/m\^2/day IV over 2 hours days 1 and 15 (up to 6 does)
|
|---|---|---|---|---|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial flutter
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Eye disorders
Retinal detachment
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
1.9%
2/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
General disorders
Extremity-lower (gait/walking)
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
General disorders
Sudden death
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Infection-Other
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
AST, SGOT
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Amylase
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
CPK (creatine phosphokinase)
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Myositis (inflammation/damage of muscle)
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Renal and urinary disorders
Renal failure
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Vascular disorders
Hypotension
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
Other adverse events
| Measure |
ATRA + Ara-C + Daunorubicin
n=105 participants at risk
ATRA 45 mg/m\^2/day orally, divided BID, Ara-C 200 mg/m\^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m\^2/day IV bolus days 3-6
|
Consolidation
n=90 participants at risk
Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m\^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m\^2/day IV bolus days 1-3 (2 courses).
|
ATRA+6-MP+MTX
n=38 participants at risk
ATRA 45 mg/m\^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m\^2/day orally daily, Methotrexate 20 mg/m\^2 orally once a week (1 year cycle).
|
Gemtuzumab Ozogamicin
n=1 participants at risk
Gemtuzumab Ozogamicin 6 mg/m\^2/day IV over 2 hours days 1 and 15 (up to 6 does)
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
37.1%
39/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
24.4%
22/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.8%
6/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
5.7%
6/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
15.2%
16/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.5%
11/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
22.9%
24/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
59.0%
62/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
8.9%
8/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
100.0%
1/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
41.0%
43/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
65.6%
59/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
57.9%
22/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.8%
7/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
2.9%
3/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
12.4%
13/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
11.1%
10/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular tachycardia
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Eye disorders
Ocular/Visual-Other
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Eye disorders
Vision-blurred vision
|
5.7%
6/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.8%
7/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Eye disorders
Vision-photophobia
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Chelitis
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
20/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
24.4%
22/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Diarrhea
|
73.3%
77/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
38.9%
35/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
28.9%
11/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
5.7%
6/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
4.4%
4/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.5%
11/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Oral cavity
|
5.7%
6/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
36.2%
38/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.6%
14/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
8.6%
9/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Nausea
|
68.6%
72/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
73.3%
66/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
68.4%
26/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
20.0%
21/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.8%
7/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
100.0%
1/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
42/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
32.2%
29/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.8%
6/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
General disorders
Edema: limb
|
23.8%
25/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
14.4%
13/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
100.0%
1/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
63.8%
67/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
77.8%
70/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
71.1%
27/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
100.0%
1/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
27.6%
29/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
17.8%
16/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
General disorders
Pain - Chest/thorax NOS
|
7.6%
8/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
17.8%
16/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
General disorders
Pain-Other
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
3.3%
3/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
100.0%
1/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
General disorders
Rigors/chills
|
29.5%
31/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
14.4%
13/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
11.4%
12/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
11.4%
12/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
|
5.7%
6/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
14.3%
15/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
11.1%
10/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
2.9%
3/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
3.3%
3/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Pharynx
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
5.7%
6/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Vagina
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Infections and infestations
Inf w/unknown ANC - Oral cavity-gums (gingivitis)
|
0.95%
1/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
100.0%
1/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
44.8%
47/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
51.1%
46/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
50.0%
19/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
AST, SGOT
|
51.4%
54/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
47.8%
43/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
50.0%
19/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Alkaline phosphatase
|
16.2%
17/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
30.0%
27/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
13.2%
5/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
35.2%
37/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.6%
14/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
21.1%
8/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Cholesterol, serum-high (hypercholesterolemia)
|
17.1%
18/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
24.4%
22/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
28.9%
11/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Creatinine
|
18.1%
19/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
14.4%
13/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Fibrinogen
|
5.7%
6/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
INR (of prothrombin time)
|
10.5%
11/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Leukocytes (total WBC)
|
33.3%
35/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
51.1%
46/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
42.1%
16/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Lymphopenia
|
20.0%
21/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
31.1%
28/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
34.2%
13/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Metabolic/Laboratory-Other
|
13.3%
14/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
16.7%
15/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
34.3%
36/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
67.8%
61/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
26.3%
10/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
PTT (Partial thromboplastin time)
|
15.2%
16/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Platelets
|
41.9%
44/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
60.0%
54/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
28.9%
11/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Prolonged QTc interval
|
9.5%
10/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
31.1%
28/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Weight gain
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Investigations
Weight loss
|
14.3%
15/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
35.2%
37/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
21.1%
19/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.8%
6/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
45/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
17.8%
16/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
13.2%
5/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
6.7%
7/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
31.4%
33/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
22.2%
20/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
13.2%
5/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
2/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
34.3%
36/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
44.4%
40/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
39.5%
15/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
11.1%
10/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
11.4%
12/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
4.4%
4/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
16.2%
17/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
17.8%
16/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.8%
6/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
15.2%
16/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
4.4%
4/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
2.9%
3/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
35.2%
37/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
21.1%
19/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
28.6%
30/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
16.7%
15/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.8%
6/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
43.8%
46/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
33.3%
30/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
47.4%
18/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.8%
7/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
9.5%
10/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
16.7%
15/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
3.3%
3/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
11.4%
12/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
11.1%
10/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
22.2%
20/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.8%
6/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
16.2%
17/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
18.9%
17/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
18.4%
7/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
6.7%
7/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
3.3%
3/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Nervous system disorders
Dizziness
|
11.4%
12/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
23.3%
21/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.8%
6/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Nervous system disorders
Hemorrhage, CNS
|
6.7%
7/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Nervous system disorders
Neuropathy: sensory
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
38.9%
35/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Nervous system disorders
Ocular/Visual-Other
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Nervous system disorders
Pain - Head/headache
|
57.1%
60/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
60.0%
54/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
52.6%
20/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
11.1%
10/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Nervous system disorders
Tremor
|
1.9%
2/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Psychiatric disorders
Confusion
|
13.3%
14/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Psychiatric disorders
Insomnia
|
17.1%
18/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
18.9%
17/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
15.8%
6/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
100.0%
1/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
14.3%
15/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
12.2%
11/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
13.2%
5/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Psychiatric disorders
Mood alteration - depression
|
13.3%
14/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
4.4%
4/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Renal and urinary disorders
Renal failure
|
7.6%
8/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
8.9%
8/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.8%
4/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
20.0%
18/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.1%
19/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
26.7%
24/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
28.9%
11/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
1.9%
2/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
12.2%
11/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
10.5%
11/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
3.3%
3/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
4.8%
5/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Respiratory, thoracic and mediastinal disorders
Retinoic acid syndrome
|
22.9%
24/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
6.7%
7/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
13.3%
12/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
10.5%
4/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.0%
20/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
25.6%
23/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
26.3%
10/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
34.3%
36/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
31.1%
28/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
13.2%
5/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage into skin or mucosa)
|
14.3%
15/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
1.1%
1/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
21.0%
22/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
16.7%
15/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
13.2%
5/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
100.0%
1/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.5%
53/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
35.6%
32/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
31.6%
12/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
15.2%
16/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Vascular disorders
Hemorrhage/Bleeding-Other
|
5.7%
6/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.2%
2/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
2.6%
1/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Vascular disorders
Hypertension
|
20.0%
21/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
7.9%
3/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Vascular disorders
Hypotension
|
13.3%
14/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
6.7%
6/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.3%
2/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
8.6%
9/105 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
5.6%
5/90 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/38 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
0.00%
0/1 • Up to 5 years
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
|
Additional Information
SWOG Leukemia Committee Statistician
SWOG Statistical Center
Phone: 206-667-4408
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place