Trial Outcomes & Findings for S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia (NCT NCT00551460)
NCT ID: NCT00551460
Last Updated: 2023-01-10
Results Overview
Binary variable: yes if the patient achieves complete remission and remains in continuous complete remission until at least 3 years after entering the study; otherwise no.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
3 years
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
ATRA + GO + Arsenic
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR
Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest
Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3
Consolidation 5 and 6: GO 9mg/m2 IV D1
Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
ATRA + GO + Arsenic
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR
Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest
Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3
Consolidation 5 and 6: GO 9mg/m2 IV D1
Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
7
|
|
Overall Study
Ineligible
|
4
|
|
Overall Study
Not analyzable (did not start treatment)
|
4
|
Baseline Characteristics
S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Baseline characteristics by cohort
| Measure |
ATRA + GO + Arsenic
n=70 Participants
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
|
|---|---|
|
Age, Continuous
|
46.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.
Binary variable: yes if the patient achieves complete remission and remains in continuous complete remission until at least 3 years after entering the study; otherwise no.
Outcome measures
| Measure |
ATRA + GO + Arsenic
n=70 Participants
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
|
|---|---|
|
Continuous Complete Remission at 3 Years
|
74 percentage of participants
Interval 62.0 to 84.0
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.
Outcome measures
| Measure |
ATRA + GO + Arsenic
n=70 Participants
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
|
|---|---|
|
Mortality Rate at 6 Weeks
|
11 percentage of participants
Interval 5.0 to 21.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.
Adverse events that were possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
ATRA + GO + Arsenic
n=70 Participants
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
|
|---|---|
|
Frequency of Toxicities
ALT, SGPT (serum glutamic pyruvic transaminase)
|
37 Participants
|
|
Frequency of Toxicities
AST, SGOT
|
46 Participants
|
|
Frequency of Toxicities
Acidosis (metabolic or respiratory)
|
4 Participants
|
|
Frequency of Toxicities
Acute vascular leak syndrome
|
1 Participants
|
|
Frequency of Toxicities
Adult respiratory distress syndrome (ARDS)
|
3 Participants
|
|
Frequency of Toxicities
Albumin, serum-low (hypoalbuminemia)
|
24 Participants
|
|
Frequency of Toxicities
Alkaline phosphatase
|
23 Participants
|
|
Frequency of Toxicities
Alkalosis (metabolic or respiratory)
|
4 Participants
|
|
Frequency of Toxicities
Allergic reaction/hypersensitivity
|
8 Participants
|
|
Frequency of Toxicities
Allergic rhinitis
|
6 Participants
|
|
Frequency of Toxicities
Allergy/Immunology-Other
|
1 Participants
|
|
Frequency of Toxicities
Anorexia
|
18 Participants
|
|
Frequency of Toxicities
Arthritis (non-septic)
|
1 Participants
|
|
Frequency of Toxicities
Ascites (non-malignant)
|
2 Participants
|
|
Frequency of Toxicities
Atelectasis
|
2 Participants
|
|
Frequency of Toxicities
Atrioventricular block - 2nd degree Mobitz Type II
|
1 Participants
|
|
Frequency of Toxicities
Atrioventricular block - first degree
|
1 Participants
|
|
Frequency of Toxicities
Auditory/Ear-Other
|
2 Participants
|
|
Frequency of Toxicities
Bicarbonate, serum-low
|
7 Participants
|
|
Frequency of Toxicities
Bilirubin (hyperbilirubinemia)
|
23 Participants
|
|
Frequency of Toxicities
Blood/Bone Marrow-Other
|
4 Participants
|
|
Frequency of Toxicities
Bronchospasm, wheezing
|
1 Participants
|
|
Frequency of Toxicities
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
8 Participants
|
|
Frequency of Toxicities
CNS cerebrovascular ischemia
|
4 Participants
|
|
Frequency of Toxicities
Calcium, serum-high (hypercalcemia)
|
1 Participants
|
|
Frequency of Toxicities
Calcium, serum-low (hypocalcemia)
|
22 Participants
|
|
Frequency of Toxicities
Carbon monoxide diffusion capacity (DL(co))
|
1 Participants
|
|
Frequency of Toxicities
Cardiac Arrhythmia-Other
|
1 Participants
|
|
Frequency of Toxicities
Cardiac General-Other
|
2 Participants
|
|
Frequency of Toxicities
Cardiac troponin I (cTnI)
|
1 Participants
|
|
Frequency of Toxicities
Cardiac troponin T (cTnT)
|
1 Participants
|
|
Frequency of Toxicities
Cardiac-ischemia/infarction
|
3 Participants
|
|
Frequency of Toxicities
Chelitis
|
1 Participants
|
|
Frequency of Toxicities
Cholesterol, serum-high (hypercholesterolemia)
|
4 Participants
|
|
Frequency of Toxicities
Confusion
|
6 Participants
|
|
Frequency of Toxicities
Constipation
|
26 Participants
|
|
Frequency of Toxicities
Cough
|
17 Participants
|
|
Frequency of Toxicities
Creatinine
|
5 Participants
|
|
Frequency of Toxicities
Cytokine release syndrome/acute infusion reaction
|
1 Participants
|
|
Frequency of Toxicities
DIC (disseminated intravascular coagulation)
|
19 Participants
|
|
Frequency of Toxicities
Dental: periodontal disease
|
1 Participants
|
|
Frequency of Toxicities
Dermal change lymphedema, phlebolymphedema
|
1 Participants
|
|
Frequency of Toxicities
Dermatology/Skin-Other
|
3 Participants
|
|
Frequency of Toxicities
Diarrhea
|
23 Participants
|
|
Frequency of Toxicities
Distention/bloating, abdominal
|
10 Participants
|
|
Frequency of Toxicities
Dizziness
|
4 Participants
|
|
Frequency of Toxicities
Dry mouth/salivary gland (xerostomia)
|
1 Participants
|
|
Frequency of Toxicities
Dry skin
|
11 Participants
|
|
Frequency of Toxicities
Dysphagia (difficulty swallowing)
|
3 Participants
|
|
Frequency of Toxicities
Dyspnea (shortness of breath)
|
27 Participants
|
|
Frequency of Toxicities
Edema, larynx
|
1 Participants
|
|
Frequency of Toxicities
Edema: head and neck
|
5 Participants
|
|
Frequency of Toxicities
Edema: limb
|
33 Participants
|
|
Frequency of Toxicities
Edema: viscera
|
2 Participants
|
|
Frequency of Toxicities
Encephalopathy
|
1 Participants
|
|
Frequency of Toxicities
Esophagitis
|
2 Participants
|
|
Frequency of Toxicities
Eyelid dysfunction
|
1 Participants
|
|
Frequency of Toxicities
Fatigue (asthenia, lethargy, malaise)
|
34 Participants
|
|
Frequency of Toxicities
Febrile neutropenia
|
29 Participants
|
|
Frequency of Toxicities
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
22 Participants
|
|
Frequency of Toxicities
Fibrinogen
|
13 Participants
|
|
Frequency of Toxicities
Flatulence
|
2 Participants
|
|
Frequency of Toxicities
Flushing
|
2 Participants
|
|
Frequency of Toxicities
GGT (gamma-glutamyl transpeptidase)
|
1 Participants
|
|
Frequency of Toxicities
Gastrointestinal-Other
|
1 Participants
|
|
Frequency of Toxicities
Glomerular filtration rate
|
2 Participants
|
|
Frequency of Toxicities
Glucose, serum-high (hyperglycemia)
|
39 Participants
|
|
Frequency of Toxicities
Glucose, serum-low (hypoglycemia)
|
1 Participants
|
|
Frequency of Toxicities
Hair loss/Alopecia (scalp or body)
|
6 Participants
|
|
Frequency of Toxicities
Hearing: pts w/o audiogram not enroll monitor prgm
|
1 Participants
|
|
Frequency of Toxicities
Heartburn/dyspepsia
|
2 Participants
|
|
Frequency of Toxicities
Hematoma
|
3 Participants
|
|
Frequency of Toxicities
Hemoglobin
|
41 Participants
|
|
Frequency of Toxicities
Hemorrhage, Respiratory tract NOS
|
3 Participants
|
|
Frequency of Toxicities
Hemorrhage, CNS
|
8 Participants
|
|
Frequency of Toxicities
Hemorrhage, GI - Lower GI NOS
|
2 Participants
|
|
Frequency of Toxicities
Hemorrhage, GI - Oral cavity
|
4 Participants
|
|
Frequency of Toxicities
Hemorrhage, GI - Rectum
|
1 Participants
|
|
Frequency of Toxicities
Hemorrhage, GI - Upper GI NOS
|
2 Participants
|
|
Frequency of Toxicities
Hemorrhage, GU - Bladder
|
1 Participants
|
|
Frequency of Toxicities
Hemorrhage, GU - Urinary NOS
|
10 Participants
|
|
Frequency of Toxicities
Hemorrhage, GU - Vagina
|
4 Participants
|
|
Frequency of Toxicities
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS
|
3 Participants
|
|
Frequency of Toxicities
Hemorrhage, pulmonary/upper respiratory - Lung
|
1 Participants
|
|
Frequency of Toxicities
Hemorrhage, pulmonary/upper respiratory - Nose
|
9 Participants
|
|
Frequency of Toxicities
Hemorrhage/Bleeding-Other
|
8 Participants
|
|
Frequency of Toxicities
Hemorrhoids
|
2 Participants
|
|
Frequency of Toxicities
Hepatobiliary/Pancreas-Other
|
2 Participants
|
|
Frequency of Toxicities
Hiccoughs (hiccups, singultus)
|
2 Participants
|
|
Frequency of Toxicities
Hot flashes/flushes
|
1 Participants
|
|
Frequency of Toxicities
Hypertension
|
25 Participants
|
|
Frequency of Toxicities
Hypotension
|
4 Participants
|
|
Frequency of Toxicities
Hypoxia
|
14 Participants
|
|
Frequency of Toxicities
INR (of prothrombin time)
|
8 Participants
|
|
Frequency of Toxicities
Ileus, GI (functional obstruction of bowel)
|
1 Participants
|
|
Frequency of Toxicities
Incontinence, anal
|
1 Participants
|
|
Frequency of Toxicities
Induration/fibrosis (skin and subcutaneous tissue)
|
1 Participants
|
|
Frequency of Toxicities
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
1 Participants
|
|
Frequency of Toxicities
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
|
1 Participants
|
|
Frequency of Toxicities
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth
|
1 Participants
|
|
Frequency of Toxicities
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
4 Participants
|
|
Frequency of Toxicities
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
|
3 Participants
|
|
Frequency of Toxicities
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
1 Participants
|
|
Frequency of Toxicities
Inf (clin/microbio) w/Gr 3-4 neuts - Stomach
|
1 Participants
|
|
Frequency of Toxicities
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2 Participants
|
|
Frequency of Toxicities
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
2 Participants
|
|
Frequency of Toxicities
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
3 Participants
|
|
Frequency of Toxicities
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
|
1 Participants
|
|
Frequency of Toxicities
Inf w/normal ANC or Gr 1-2 neutrophils - Vagina
|
2 Participants
|
|
Frequency of Toxicities
Inf w/unknown ANC - Oral cavity-gums (gingivitis)
|
1 Participants
|
|
Frequency of Toxicities
Infection (documented clinically or microbiologica
|
1 Participants
|
|
Frequency of Toxicities
Infection with unknown ANC - Blood
|
2 Participants
|
|
Frequency of Toxicities
Infection with unknown ANC - Lung (pneumonia)
|
5 Participants
|
|
Frequency of Toxicities
Infection-Other
|
1 Participants
|
|
Frequency of Toxicities
Injection site reaction/extravasation changes
|
3 Participants
|
|
Frequency of Toxicities
Insomnia
|
19 Participants
|
|
Frequency of Toxicities
Leak (including anastomotic), GU - Bladder
|
1 Participants
|
|
Frequency of Toxicities
Left ventricular systolic dysfunction
|
3 Participants
|
|
Frequency of Toxicities
Leukocytes (total WBC)
|
26 Participants
|
|
Frequency of Toxicities
Liver dysfunction/failure (clinical)
|
1 Participants
|
|
Frequency of Toxicities
Lymphopenia
|
19 Participants
|
|
Frequency of Toxicities
Magnesium, serum-high (hypermagnesemia)
|
16 Participants
|
|
Frequency of Toxicities
Magnesium, serum-low (hypomagnesemia)
|
8 Participants
|
|
Frequency of Toxicities
Mental status
|
1 Participants
|
|
Frequency of Toxicities
Metabolic/Laboratory-Other
|
8 Participants
|
|
Frequency of Toxicities
Mood alteration - agitation
|
3 Participants
|
|
Frequency of Toxicities
Mood alteration - anxiety
|
14 Participants
|
|
Frequency of Toxicities
Mood alteration - depression
|
10 Participants
|
|
Frequency of Toxicities
Mucositis/stomatitis (clinical exam) - Oral cavity
|
2 Participants
|
|
Frequency of Toxicities
Mucositis/stomatitis (functional/symp) - Oral cav
|
6 Participants
|
|
Frequency of Toxicities
Muscle weakness, not d/t neuropathy - Extrem-lower
|
1 Participants
|
|
Frequency of Toxicities
Muscle weakness, not d/t neuropathy - body/general
|
9 Participants
|
|
Frequency of Toxicities
Musculoskeletal/Soft Tissue-Other
|
3 Participants
|
|
Frequency of Toxicities
Nasal cavity/paranasal sinus reactions
|
3 Participants
|
|
Frequency of Toxicities
Nausea
|
40 Participants
|
|
Frequency of Toxicities
Neurology-Other
|
2 Participants
|
|
Frequency of Toxicities
Neuropathy: cranial - CN II Vision
|
1 Participants
|
|
Frequency of Toxicities
Neuropathy: motor
|
4 Participants
|
|
Frequency of Toxicities
Neuropathy: sensory
|
3 Participants
|
|
Frequency of Toxicities
Neutrophils/granulocytes (ANC/AGC)
|
38 Participants
|
|
Frequency of Toxicities
Obstruction, GU - Bladder
|
1 Participants
|
|
Frequency of Toxicities
Ocular/Visual-Other
|
5 Participants
|
|
Frequency of Toxicities
Optic disc edema
|
2 Participants
|
|
Frequency of Toxicities
PTT (Partial thromboplastin time)
|
13 Participants
|
|
Frequency of Toxicities
Pain - Abdomen NOS
|
14 Participants
|
|
Frequency of Toxicities
Pain - Back
|
8 Participants
|
|
Frequency of Toxicities
Pain - Bone
|
2 Participants
|
|
Frequency of Toxicities
Pain - Buttock
|
1 Participants
|
|
Frequency of Toxicities
Pain - Cardiac/heart
|
1 Participants
|
|
Frequency of Toxicities
Pain - Chest/thorax NOS
|
9 Participants
|
|
Frequency of Toxicities
Pain - Dental/teeth/peridontal
|
1 Participants
|
|
Frequency of Toxicities
Pain - Esophagus
|
2 Participants
|
|
Frequency of Toxicities
Pain - Extremity-limb
|
5 Participants
|
|
Frequency of Toxicities
Pain - Eye
|
2 Participants
|
|
Frequency of Toxicities
Pain - Face
|
1 Participants
|
|
Frequency of Toxicities
Pain - Head/headache
|
44 Participants
|
|
Frequency of Toxicities
Pain - Joint
|
7 Participants
|
|
Frequency of Toxicities
Pain - Muscle
|
7 Participants
|
|
Frequency of Toxicities
Pain - Neck
|
3 Participants
|
|
Frequency of Toxicities
Pain - Oral cavity
|
2 Participants
|
|
Frequency of Toxicities
Pain - Pleura
|
1 Participants
|
|
Frequency of Toxicities
Pain - Sinus
|
1 Participants
|
|
Frequency of Toxicities
Pain - Stomach
|
1 Participants
|
|
Frequency of Toxicities
Pain - Throat/pharynx/larynx
|
8 Participants
|
|
Frequency of Toxicities
Pain - Urethra
|
2 Participants
|
|
Frequency of Toxicities
Pain-Other
|
6 Participants
|
|
Frequency of Toxicities
Petechiae/purpura (hemorrhage into skin or mucosa)
|
15 Participants
|
|
Frequency of Toxicities
Phosphate, serum-low (hypophosphatemia)
|
7 Participants
|
|
Frequency of Toxicities
Platelets
|
40 Participants
|
|
Frequency of Toxicities
Pleural effusion (non-malignant)
|
9 Participants
|
|
Frequency of Toxicities
Pneumonitis/pulmonary infiltrates
|
3 Participants
|
|
Frequency of Toxicities
Potassium, serum-high (hyperkalemia)
|
9 Participants
|
|
Frequency of Toxicities
Potassium, serum-low (hypokalemia)
|
28 Participants
|
|
Frequency of Toxicities
Prolonged QTc interval
|
21 Participants
|
|
Frequency of Toxicities
Proteinuria
|
6 Participants
|
|
Frequency of Toxicities
Pruritus/itching
|
12 Participants
|
|
Frequency of Toxicities
Psychosis (hallucinations/delusions)
|
1 Participants
|
|
Frequency of Toxicities
Pulmonary/Upper Respiratory-Other
|
5 Participants
|
|
Frequency of Toxicities
Rash/desquamation
|
26 Participants
|
|
Frequency of Toxicities
Renal failure
|
4 Participants
|
|
Frequency of Toxicities
Renal/Genitourinary-Other
|
2 Participants
|
|
Frequency of Toxicities
Retinoic acid syndrome
|
6 Participants
|
|
Frequency of Toxicities
Rigors/chills
|
7 Participants
|
|
Frequency of Toxicities
SVT and nodal arrhythmia - Atrial fibrillation
|
1 Participants
|
|
Frequency of Toxicities
SVT and nodal arrhythmia - SVT arrhythmia NOS
|
1 Participants
|
|
Frequency of Toxicities
SVT and nodal arrhythmia - Sinus arrhythmia
|
3 Participants
|
|
Frequency of Toxicities
SVT and nodal arrhythmia - Sinus bradycardia
|
5 Participants
|
|
Frequency of Toxicities
SVT and nodal arrhythmia - Sinus tachycardia
|
20 Participants
|
|
Frequency of Toxicities
Seizure
|
1 Participants
|
|
Frequency of Toxicities
Sodium, serum-high (hypernatremia)
|
5 Participants
|
|
Frequency of Toxicities
Sodium, serum-low (hyponatremia)
|
19 Participants
|
|
Frequency of Toxicities
Soft tissue necrosis - Extremity-lower
|
1 Participants
|
|
Frequency of Toxicities
Somnolence/depressed level of consciousness
|
6 Participants
|
|
Frequency of Toxicities
Speech impairment (e.g., dysphasia or aphasia)
|
1 Participants
|
|
Frequency of Toxicities
Stricture/stenosis (incl anastomotic) GI - Pharynx
|
1 Participants
|
|
Frequency of Toxicities
Sweating (diaphoresis)
|
9 Participants
|
|
Frequency of Toxicities
Syncope (fainting)
|
2 Participants
|
|
Frequency of Toxicities
Syndromes-Other
|
4 Participants
|
|
Frequency of Toxicities
Taste alteration (dysgeusia)
|
2 Participants
|
|
Frequency of Toxicities
Thrombosis/embolism (vascular access-related)
|
1 Participants
|
|
Frequency of Toxicities
Thrombosis/thrombus/embolism
|
2 Participants
|
|
Frequency of Toxicities
Thyroid function, low (hypothyroidism)
|
1 Participants
|
|
Frequency of Toxicities
Triglyceride, serum-high (hypertriglyceridemia)
|
11 Participants
|
|
Frequency of Toxicities
Ulceration
|
2 Participants
|
|
Frequency of Toxicities
Uric acid, serum-high (hyperuricemia)
|
2 Participants
|
|
Frequency of Toxicities
Urinary frequency/urgency
|
1 Participants
|
|
Frequency of Toxicities
Urinary retention (including neurogenic bladder)
|
4 Participants
|
|
Frequency of Toxicities
Urine color change
|
1 Participants
|
|
Frequency of Toxicities
Vaginal discharge (non-infectious)
|
1 Participants
|
|
Frequency of Toxicities
Ventricular arrhythmia - PVCs
|
1 Participants
|
|
Frequency of Toxicities
Ventricular arrhythmia - Ventricular tachycardia
|
1 Participants
|
|
Frequency of Toxicities
Vision-blurred vision
|
7 Participants
|
|
Frequency of Toxicities
Vision-flashing lights/floaters
|
2 Participants
|
|
Frequency of Toxicities
Vision-photophobia
|
4 Participants
|
|
Frequency of Toxicities
Vitreous hemorrhage
|
3 Participants
|
|
Frequency of Toxicities
Voice changes/dysarthria
|
1 Participants
|
|
Frequency of Toxicities
Vomiting
|
33 Participants
|
|
Frequency of Toxicities
Watery eye (epiphora, tearing)
|
2 Participants
|
|
Frequency of Toxicities
Weight gain
|
3 Participants
|
|
Frequency of Toxicities
Weight loss
|
9 Participants
|
Adverse Events
ATRA + GO + Arsenic
Serious events: 11 serious events
Other events: 68 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
ATRA + GO + Arsenic
n=70 participants at risk
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR
|
|---|---|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
2.9%
2/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
Cardiac General-Other
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel)
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
2.9%
2/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
2.9%
2/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
AST, SGOT
|
2.9%
2/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Carbon monoxide diffusion capacity (DL(co))
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Leukocytes (total WBC)
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Platelets
|
4.3%
3/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Hemorrhage, CNS
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other
|
2.9%
2/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
2/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Retinoic acid syndrome
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
Other adverse events
| Measure |
ATRA + GO + Arsenic
n=70 participants at risk
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
37.1%
26/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
12.9%
9/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
17.1%
12/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
11.4%
8/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
24.3%
17/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
41.4%
29/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
57.1%
40/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus bradycardia
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
27.1%
19/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Eye disorders
Ocular/Visual-Other
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Eye disorders
Vision-blurred vision
|
10.0%
7/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Eye disorders
Vision-photophobia
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Constipation
|
37.1%
26/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
32.9%
23/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
14.3%
10/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Oral cavity
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
8.6%
6/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
40/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
20.0%
14/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Gastrointestinal disorders
Vomiting
|
47.1%
33/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Edema: head and neck
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Edema: limb
|
47.1%
33/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
48.6%
34/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
31.4%
22/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Pain - Chest/thorax NOS
|
12.9%
9/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Pain-Other
|
8.6%
6/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Rigors/chills
|
10.0%
7/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
General disorders
Syndromes-Other
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
11.4%
8/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
11.4%
8/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
51.4%
36/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
AST, SGOT
|
62.9%
44/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Alkaline phosphatase
|
32.9%
23/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
31.4%
22/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Cholesterol, serum-high (hypercholesterolemia)
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Creatinine
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Fibrinogen
|
18.6%
13/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
INR (of prothrombin time)
|
11.4%
8/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Leukocytes (total WBC)
|
35.7%
25/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Lymphopenia
|
27.1%
19/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Metabolic/Laboratory-Other
|
11.4%
8/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
52.9%
37/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
PTT (Partial thromboplastin time)
|
18.6%
13/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Platelets
|
52.9%
37/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Prolonged QTc interval
|
30.0%
21/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Investigations
Weight loss
|
12.9%
9/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
34.3%
24/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.7%
18/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
10.0%
7/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
31.4%
22/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
55.7%
39/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
22.9%
16/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
11.4%
8/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
10.0%
7/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
12.9%
9/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
40.0%
28/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
27.1%
19/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
15.7%
11/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
12.9%
9/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
11.4%
8/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
10.0%
7/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
10.0%
7/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Dizziness
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Hemorrhage, CNS
|
10.0%
7/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Neuropathy: motor
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Ocular/Visual-Other
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Pain - Head/headache
|
62.9%
44/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Confusion
|
8.6%
6/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Insomnia
|
27.1%
19/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
20.0%
14/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Psychiatric disorders
Mood alteration - depression
|
14.3%
10/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
14.3%
10/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Proteinuria
|
8.6%
6/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Renal failure
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Reproductive system and breast disorders
Hemorrhage, GU - Vagina
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.6%
6/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.3%
17/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
12.9%
9/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Retinoic acid syndrome
|
7.1%
5/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.7%
11/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
8.6%
6/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage into skin or mucosa)
|
21.4%
15/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
17.1%
12/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
37.1%
26/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
12.9%
9/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hemorrhage/Bleeding-Other
|
11.4%
8/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hypertension
|
34.3%
24/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Vascular disorders
Hypotension
|
5.7%
4/70 • Up to 3 years
Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
|
Additional Information
Leukemia Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60