Leukemia
Conditions
Keywords
adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute promyelocytic leukemia (M3), untreated adult acute myeloid leukemia
Brief summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Sometimes the cancer may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether combination chemotherapy is more effective than observation when given as maintenance therapy in treating acute promyelocytic leukemia. PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and methotrexate to see how well they work when given as maintenance therapy compared with observation after combination chemotherapy in treating patients with acute promyelocytic leukemia. (Randomization and observation group closed as of 8/15/10)
Detailed description
OBJECTIVES: * Compare disease-free survival (DFS) among patients with previously untreated low and intermediate risk acute promyelocytic leukemia (APL) who are PCR-negative for Promyelocytic-retinoic acid receptor alpha (PML-RARα) after consolidation therapy and receive maintenance therapy versus patients who receive no maintenance therapy. (Randomization and observation arm closed as of 8/15/10) * Assess the toxicity of induction, consolidation and maintenance in these patients. * Test whether gene expression profiles assessed prior to treatment are predictive of resistance to remission induction chemotherapy and correlate with detectable minimal residual disease post-consolidation therapy. (Only one patient was not in molecular remission after receiving consolidation. Therefore, the predictive value of pre-treatment gene expression profiling could not be determined and is not reported here). * Investigate in a preliminarily manner the outcomes of patients who fail to achieve or maintain PCR-negative PML-RARα fusion gene after consolidation therapy when treated with gemtuzumab ozogamicin. (Only one patient was treated with gemtuzumab ozogamicin as part of protocol treatment. Therefore, results for this objective are not reported). OUTLINE: This is a randomized, multicenter study. * Induction therapy: Patients receive oral tretinoin twice daily until morphologic complete remission (CR) or for a maximum of 90 days in the absence of disease progression or unacceptable toxicity. Patients also receive cytarabine IV continuously on days 3-9 and daunorubicin hydrochloride IV on days 3-6. * Consolidation therapy: Patients who achieve CR, CR with incomplete blood count recovery (CRi), or partial remission (PR) after induction therapy receive arsenic trioxide IV over 2 hours 5 days a week for 5 weeks. After a 2-week rest period, patients receive a second course of arsenic trioxide. Within 14-30 days after blood count recovery, patients receive oral tretinoin twice daily on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients receive a second course of tretinoin and daunorubicin hydrochloride after adequate blood count recovery. * Post-consolidation therapy: Patients who do not achieve molecular CR (CRm), but do achieve CR or CRi and are still PML-RARα-positive after consolidation therapy, receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment repeats every 14 days for up to 6 courses or until PML-RARα-negative by PCR. (closed as of 8/15/10)Patients are stratified according to age (18 to 60 years vs \> 60 years), acute promyelocytic leukemia (APL) risk group (low vs intermediate), and if the patient received consolidation therapy courses 3 or 4 (yes vs no) regardless of their CRm response. These patients are randomized to 1 of 2 treatment arms. (Randomization and observation arm closed as of 8/15/10) All patients are non-randomly assigned to receive post-consolidation therapy. * Arm I: Beginning 14-30 days after blood count recovery, patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year. * Arm II: Patients receive no further chemotherapy. Patients are followed every 3 months for 1 year. (Randomization and observation arm closed as of 8/15/10) Patients undergo blood collection periodically for cytogenetic studies. Samples are analyzed for PML-RARα fusion gene via reverse transcriptase-polymerase chain reaction (RT-PCR) assay and gene expression profiling. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
Interventions
DRUGmercaptopurine
Given orally
DRUGmethotrexate
Given orally
DRUGtretinoin
Given orally
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Cytologically confirmed acute promyelocytic leukemia (APL) or the variant form of APL * Previously untreated disease * Low- or intermediate-risk disease * Low-risk disease, defined as white blood cell (WBC) ≤ 10,000/mm\^3 and platelet count \> 40,000/mm\^3 * Intermediate-risk disease, defined as WBC ≤ 10,000/mm\^3 and platelet count ≤ 40,000/mm\^3 * WBC and platelet count confirming low- or intermediate-risk disease must be obtained within 48 hours prior to study registration unless the patient received tretinoin therapy prior to study registration in which case the WBC and platelet count must be obtained within 48 hours prior to study therapy * PML-RARα fusion gene positive by reverse transcriptase-polymerase chain reaction (RT-PCR) assay * No recurrent disease * Must be registered on clinical trials SWOG-9007 and SWOG-S9910 * Specimens must be collected prior to tretinoin therapy and may be collected after tretinoin therapy PATIENT CHARACTERISTICS: * Zubrod performance status 0-3 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for ≥ 1 month prior to, during, and for 2 months after completion of study treatment * No unstable cardiac arrhythmia or unstable angina * No other malignancy within the past 5 years except for the following: * Adequately treated basal cell or squamous cell skin cancer * Carcinoma in situ of the cervix * Adequately treated stage I or II cancer (except for highly aggressive malignancies with a high rate of early relapse) currently in complete remission PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 1 prior dose of intrathecal chemotherapy for acute leukemia * No prior systemic chemotherapy, hydroxyurea, or leukapheresis for acute leukemia * Prior tretinoin at a dose of ≤ 45 mg/m\^2/day allowed provided it was received ≤ 5 days prior to study registration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Disease-free Survival (DFS) Rate | Up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Up to 5 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). 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. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Consolidation | Adverse Event | 6 | 0 | 0 | 0 |
| Consolidation | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Consolidation | Not protocol specified | 2 | 0 | 0 | 0 |
| Induction | Adverse Event | 2 | 0 | 0 | 0 |
| Induction | Death | 3 | 0 | 0 | 0 |
| Induction | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Post-consolidation | Adverse Event | 0 | 4 | 0 | 1 |
| Post-consolidation | Death | 0 | 1 | 0 | 0 |
| Post-consolidation | Lost to Follow-up | 0 | 2 | 0 | 0 |
| Post-consolidation | Not protocol specified | 0 | 1 | 0 | 0 |
| Post-consolidation | Observation Arm | 0 | 0 | 27 | 0 |
| Post-consolidation | Withdrawal by Subject | 0 | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | Low and Intermediate Risk APL Patients |
|---|---|
| Age, Continuous | 49 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 105 / 105 | 89 / 90 | 37 / 38 | 1 / 1 |
| serious Total, serious adverse events | 8 / 105 | 4 / 90 | 1 / 38 | 0 / 1 |
Outcome results
Primary
3-year Disease-free Survival (DFS) Rate
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.
Time frame: Up to 3 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATRA + Ara-C + Daunorubicin | 3-year Disease-free Survival (DFS) Rate | 96 percentage of patients |
| Consolidation | 3-year Disease-free Survival (DFS) Rate | 100 percentage of patients |
Secondary
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
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.
Time frame: Up to 5 years
Population: Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Coagulation-Other (Specify) | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Nausea | 6 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 42 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Photosensitivity | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Confusion | 4 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Myositis (inflammation/damage of muscle) | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 7 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Creatinine | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Rectum | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pericarditis | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pericardial effusion (non-malignant) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | DIC (disseminated intravascular coagulation) | 11 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 3 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Throat/pharynx/larynx | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Scrotum | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 0 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Rectum | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Neck | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 11 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-Other (Specify) | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 3 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Distention/bloating, abdominal | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vasovagal episode | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 10 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dizziness | 1 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 11 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dry skin | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dysphagia (difficulty swallowing) | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Rectum | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 3 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 1 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Metabolic/Laboratory-Other (Specify) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Back | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 20 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 34 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Skin (cellulitis) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac troponin T (cTnT) | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Bladder (urinary) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vomiting | 1 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Weight gain | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Typhlitis (cecal inflammation) | 3 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Enteritis (inflammation of the small bowel) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Triglyceride, serum-high (hypertriglyceridemia) | 5 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Extremity-lower (gait/walking) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 3 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 58 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 4 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Retinoic acid syndrome | 13 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Flu-like syndrome | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 8 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 5 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 3 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Lung | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypoxia | 6 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypotension | 1 Participants |
| ATRA + Ara-C + Daunorubicin | 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 |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GU - Vagina | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 4 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 34 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Rectum | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypertension | 3 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 37 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 4 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Alkalosis (metabolic or respiratory) | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Ventricular arrhythmia - Ventricular tachycardia | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Retinal detachment | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Restrictive cardiomyopathy | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 4 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Renal/Genitourinary-Other (Specify) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Renal failure | 7 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 7 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 3 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 0 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | CPK (creatine phosphokinase) | 2 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac Arrhythmia-Other (Specify) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Prolonged QTc interval | 3 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 4 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cholesterol, serum-high (hypercholesterolemia) | 1 Participants |
| ATRA + Ara-C + Daunorubicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Acidosis (metabolic or respiratory) | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Nausea | 4 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac Arrhythmia-Other (Specify) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac troponin T (cTnT) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypertension | 1 Participants |
| Consolidation | 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 | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Rectum | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-Other (Specify) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 4 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Petechiae/purpura (hemorrhage into skin or mucosa) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Retinoic acid syndrome | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Weight gain | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Enteritis (inflammation of the small bowel) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Extremity-lower (gait/walking) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 5 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 8 Participants |
| Consolidation | 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 |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Flu-like syndrome | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 3 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 2 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Acidosis (metabolic or respiratory) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Alkalosis (metabolic or respiratory) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | CPK (creatine phosphokinase) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cholesterol, serum-high (hypercholesterolemia) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Coagulation-Other (Specify) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Confusion | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Creatinine | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | DIC (disseminated intravascular coagulation) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Distention/bloating, abdominal | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dizziness | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dry skin | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dysphagia (difficulty swallowing) | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Back | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 2 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 3 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 2 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Neck | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Rectum | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Scrotum | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Throat/pharynx/larynx | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pericardial effusion (non-malignant) | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pericarditis | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Photosensitivity | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 18 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Prolonged QTc interval | 6 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Renal failure | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Renal/Genitourinary-Other (Specify) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Restrictive cardiomyopathy | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Retinal detachment | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 5 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 4 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Rectum | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GU - Vagina | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Lung | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypotension | 2 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| Consolidation | 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 | 0 Participants |
| Consolidation | 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 | 0 Participants |
| Consolidation | 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 | 0 Participants |
| Consolidation | 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 | 0 Participants |
| Consolidation | 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 | 0 Participants |
| Consolidation | 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 |
| Consolidation | 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 | 0 Participants |
| Consolidation | 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 | 0 Participants |
| Consolidation | 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 | 0 Participants |
| Consolidation | 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 |
| Consolidation | 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 | 5 Participants |
| Consolidation | 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 | 1 Participants |
| Consolidation | 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 | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/unknown ANC - Oral cavity-gums (gingivitis) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Bladder (urinary) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Skin (cellulitis) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 3 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 37 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 20 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Rectum | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - Extrem-lower | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - Extrem-upper | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Myositis (inflammation/damage of muscle) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 2 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 55 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Opportunistic inf associated w/gt=Gr 2 lymphopenia | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Triglyceride, serum-high (hypertriglyceridemia) | 2 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Typhlitis (cecal inflammation) | 0 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vasovagal episode | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Ventricular arrhythmia - Ventricular tachycardia | 1 Participants |
| Consolidation | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vomiting | 1 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 1 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Nausea | 1 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Renal failure | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Renal/Genitourinary-Other (Specify) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac Arrhythmia-Other (Specify) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Alkalosis (metabolic or respiratory) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Retinal detachment | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 3 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Rectum | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GU - Vagina | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Lung | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Acidosis (metabolic or respiratory) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vasovagal episode | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 4 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 1 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 0 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Flu-like syndrome | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 1 Participants |
| ATRA+6-MP+MTX | 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 |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | 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 | 1 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| ATRA+6-MP+MTX | 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 | 1 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 0 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 1 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Enteritis (inflammation of the small bowel) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Extremity-lower (gait/walking) | 0 Participants |
| ATRA+6-MP+MTX | 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 | 1 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Weight gain | 0 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Retinoic acid syndrome | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| ATRA+6-MP+MTX | 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 |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Ventricular arrhythmia - Ventricular tachycardia | 0 Participants |
| ATRA+6-MP+MTX | 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 | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Restrictive cardiomyopathy | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/unknown ANC - Oral cavity-gums (gingivitis) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Bladder (urinary) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Rectum | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Scrotum | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Skin (cellulitis) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-Other (Specify) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 3 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 3 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Triglyceride, serum-high (hypertriglyceridemia) | 3 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Myositis (inflammation/damage of muscle) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac troponin T (cTnT) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 1 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dry skin | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dysphagia (difficulty swallowing) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Typhlitis (cecal inflammation) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Rectum | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Back | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dizziness | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Distention/bloating, abdominal | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 6 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 7 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Neck | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - Extrem-lower | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Rectum | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | DIC (disseminated intravascular coagulation) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Throat/pharynx/larynx | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vomiting | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pericardial effusion (non-malignant) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Creatinine | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - Extrem-upper | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pericarditis | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Petechiae/purpura (hemorrhage into skin or mucosa) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Confusion | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Photosensitivity | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Coagulation-Other (Specify) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 2 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cholesterol, serum-high (hypercholesterolemia) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | CPK (creatine phosphokinase) | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Prolonged QTc interval | 0 Participants |
| ATRA+6-MP+MTX | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 1 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Lung (pneumonia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Rectum | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Ventricular arrhythmia - Ventricular tachycardia | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dehydration | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac Arrhythmia-Other (Specify) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection-Other (Specify) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Renal/Genitourinary-Other (Specify) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Alkalosis (metabolic or respiratory) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Coagulation-Other (Specify) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Neck | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Myositis (inflammation/damage of muscle) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Flu-like syndrome | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vomiting | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Photosensitivity | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cardiac troponin T (cTnT) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Rectum | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Rectum | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Acidosis (metabolic or respiratory) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | DIC (disseminated intravascular coagulation) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Lung | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Nausea | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - Extrem-lower | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | CPK (creatine phosphokinase) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Skin (cellulitis) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Triglyceride, serum-high (hypertriglyceridemia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Throat/pharynx/larynx | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Vasovagal episode | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Creatinine | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Weight gain | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Platelets | 0 Participants |
| Gemtuzumab Ozogamicin | 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 |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 1 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GU - Vagina | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dry skin | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pericardial effusion (non-malignant) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 0 Participants |
| Gemtuzumab Ozogamicin | 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 |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Cholesterol, serum-high (hypercholesterolemia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dysphagia (difficulty swallowing) | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dizziness | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Extremity-lower (gait/walking) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Enteritis (inflammation of the small bowel) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Retinoic acid syndrome | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pericarditis | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Back | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Confusion | 0 Participants |
| Gemtuzumab Ozogamicin | 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 |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Rectum | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pleural effusion (non-malignant) | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Distention/bloating, abdominal | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 0 Participants |
| Gemtuzumab Ozogamicin | 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 |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Retinal detachment | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Petechiae/purpura (hemorrhage into skin or mucosa) | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Restrictive cardiomyopathy | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Typhlitis (cecal inflammation) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Prolonged QTc interval | 0 Participants |
| Gemtuzumab Ozogamicin | 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 | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Inf w/unknown ANC - Oral cavity-gums (gingivitis) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Renal failure | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - Extrem-upper | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Bladder (urinary) | 0 Participants |
| Gemtuzumab Ozogamicin | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Pain - Scrotum | 0 Participants |