Trial Outcomes & Findings for Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT00416598)

Last Updated: 2019-02-19

Results Overview

To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

546 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2019-02-19

Participant Flow

Between November 2006 and July 2010, 546 participants were recruited.

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy, PBSC or Bone Marrow Transplantation) See Detailed Description: Patients undergo induction therapy comprising cytarabine and daunorubicin hydrochloride. Patient with RD undergo second induction therapy comprising cytarabine, daunorubicin hydrochloride, and etoposide. Patients with CR and favorable cytogenetics who achieve CR receive intensification therapy comprising high-dose cytarabine. Patients with UC receive etoposide, high-dose cytarabine, G-CSF., and busulfan and proceed to PBSC or bone marrow transplantation. Patients with UC and unable to undergo transplantation receive etoposide, high-dose cytarabine, and G-CSF. Patients then receive decitabine as maintenance therapy.
Induction & Intensification STARTED	546
Induction & Intensification COMPLETED	134
Induction & Intensification NOT COMPLETED	412
Decitabine Maintenance STARTED	134
Decitabine Maintenance COMPLETED	62
Decitabine Maintenance NOT COMPLETED	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Chemotherapy, PBSC or Bone Marrow Transplantation) See Detailed Description: Patients undergo induction therapy comprising cytarabine and daunorubicin hydrochloride. Patient with RD undergo second induction therapy comprising cytarabine, daunorubicin hydrochloride, and etoposide. Patients with CR and favorable cytogenetics who achieve CR receive intensification therapy comprising high-dose cytarabine. Patients with UC receive etoposide, high-dose cytarabine, G-CSF., and busulfan and proceed to PBSC or bone marrow transplantation. Patients with UC and unable to undergo transplantation receive etoposide, high-dose cytarabine, and G-CSF. Patients then receive decitabine as maintenance therapy.
Induction & Intensification Adverse Event	38
Induction & Intensification Death	32
Induction & Intensification Withdrawal by Subject	46
Induction & Intensification Alternative Treatment	135
Induction & Intensification Physician discretion/other medical issue	45
Induction & Intensification Relapse/progression	29
Induction & Intensification Failed induction	87
Decitabine Maintenance Adverse Event	5
Decitabine Maintenance Withdrawal by Subject	18
Decitabine Maintenance Progression/relapse	38
Decitabine Maintenance Alternative treatment	2
Decitabine Maintenance Physician discretion/other medical issue	9

Baseline Characteristics

Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decatibine Maintenance n=134 Participants Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m\^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants
Region of Enrollment United States	134 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.

Outcome measures

Outcome measures
Measure	Decatibine Maintenance n=134 Participants Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m\^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
Number of Participants Who Completed Maintenance Decitabine.	62 participants

PRIMARY outcome

Timeframe: At 1 year

For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method A CR is defined as those with \> 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, \<5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils \> 1000 mL and platelets \>= 100,000 mL).

Outcome measures

Outcome measures
Measure	Decatibine Maintenance n=134 Participants Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m\^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
Disease-free Survival (DFS) Rate at 1 Year	80 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline, after 2, 4, and 6 hours after the start of busulfan infusion

Results from busulfan pharmacokinetics will be pooled with those from CALGB 19808.

Outcome measures

Outcome data not reported

Adverse Events

Decatibine Maintenance

Serious events: 0 serious events

Other events: 130 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Decatibine Maintenance n=132 participants at risk Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m\^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
Blood and lymphatic system disorders Febrile neutropenia	12.1% 16/132 • Number of events 18 132 participants were assessed for adverse events during decitabine maintenance
Blood and lymphatic system disorders Hemoglobin decreased	94.7% 125/132 • Number of events 488 132 participants were assessed for adverse events during decitabine maintenance
Blood and lymphatic system disorders Lymphatic disorder	0.76% 1/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Atrial tachycardia	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Cardiac disorder	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Cardiac pain	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Left ventricular dysfunction	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Left ventricular failure	3.8% 5/132 • Number of events 7 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Palpitations	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Restrictive cardiomyopathy	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Sinus bradycardia	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Cardiac disorders Sinus tachycardia	8.3% 11/132 • Number of events 16 132 participants were assessed for adverse events during decitabine maintenance
Ear and labyrinth disorders Ear disorder	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Ear and labyrinth disorders Ear pain	3.0% 4/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Ear and labyrinth disorders Hearing impaired	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Ear and labyrinth disorders Middle ear inflammation	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Ear and labyrinth disorders Tinnitus	3.0% 4/132 • Number of events 7 132 participants were assessed for adverse events during decitabine maintenance
Endocrine disorders Hypothyroidism	0.76% 1/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Eye disorders Conjunctivitis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Eye disorders Diplopia	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Eye disorders Dry eye syndrome	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Eye disorders Eye disorder	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Eye disorders Eye pain	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Eye disorders Flashing vision	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Eye disorders Photophobia	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Eye disorders Vision blurred	4.5% 6/132 • Number of events 7 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Abdominal distension	2.3% 3/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Abdominal pain	15.9% 21/132 • Number of events 25 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Anal exam abnormal	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Ascites	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Constipation	22.7% 30/132 • Number of events 52 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Diarrhea	21.2% 28/132 • Number of events 47 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Dry mouth	3.0% 4/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Dyspepsia	6.1% 8/132 • Number of events 8 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Dysphagia	3.8% 5/132 • Number of events 9 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Ear, nose and throat examination abnormal	3.8% 5/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Esophageal pain	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Esophagitis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Flatulence	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Gastritis	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Gastrointestinal disorder	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Gingival pain	3.0% 4/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Hemorrhoids	3.8% 5/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.76% 1/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Mucositis oral	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Nausea	48.5% 64/132 • Number of events 161 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Oral pain	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Rectal hemorrhage	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Rectal pain	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Salivary gland disorder	0.76% 1/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Small intestinal stenosis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Stomach pain	2.3% 3/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Tooth disorder	1.5% 2/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Toothache	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Gastrointestinal disorders Vomiting	19.7% 26/132 • Number of events 41 132 participants were assessed for adverse events during decitabine maintenance
General disorders Chest pain	5.3% 7/132 • Number of events 7 132 participants were assessed for adverse events during decitabine maintenance
General disorders Chills	12.1% 16/132 • Number of events 19 132 participants were assessed for adverse events during decitabine maintenance
General disorders Edema limbs	12.1% 16/132 • Number of events 28 132 participants were assessed for adverse events during decitabine maintenance
General disorders Fatigue	67.4% 89/132 • Number of events 283 132 participants were assessed for adverse events during decitabine maintenance
General disorders Fever	11.4% 15/132 • Number of events 16 132 participants were assessed for adverse events during decitabine maintenance
General disorders Flu-like symptoms	1.5% 2/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
General disorders General symptom	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
General disorders Ill-defined disorder	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
General disorders Injection site reaction	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
General disorders Localized edema	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
General disorders Pain	15.2% 20/132 • Number of events 26 132 participants were assessed for adverse events during decitabine maintenance
General disorders Visceral edema	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Hepatobiliary disorders Cholecystitis	1.5% 2/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Hepatobiliary disorders Hepatobiliary disease	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Immune system disorders Autoimmune disorder	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Immune system disorders Hypersensitivity	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Immune system disorders Immune system disorder	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Abdominal infection	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Bladder infection	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Bronchitis	3.8% 5/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Catheter related infection	5.3% 7/132 • Number of events 9 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Conjunctivitis infective	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Gingival infection	2.3% 3/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Infection	7.6% 10/132 • Number of events 13 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Lip infection	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Mucosal infection	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Opportunistic infection	1.5% 2/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Otitis media	2.3% 3/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Peripheral nerve infection	1.5% 2/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Pharyngitis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Pneumonia	6.1% 8/132 • Number of events 9 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Sepsis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Sinusitis	7.6% 10/132 • Number of events 10 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Skin infection	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Soft tissue infection	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Upper aerodigestive tract infection	0.76% 1/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Upper respiratory infection	11.4% 15/132 • Number of events 17 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Ureteritis	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Urinary tract infection	2.3% 3/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Infections and infestations Vaginal infection	0.76% 1/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Injury, poisoning and procedural complications Bruising	3.8% 5/132 • Number of events 7 132 participants were assessed for adverse events during decitabine maintenance
Injury, poisoning and procedural complications Fracture	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Injury, poisoning and procedural complications Thermal burn	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Injury, poisoning and procedural complications Vascular access complication	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Injury, poisoning and procedural complications Wound dehiscence	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Investigations Activated partial thromboplastin time prolonged	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Investigations Alanine aminotransferase increased	43.2% 57/132 • Number of events 159 132 participants were assessed for adverse events during decitabine maintenance
Investigations Alkaline phosphatase increased	19.7% 26/132 • Number of events 74 132 participants were assessed for adverse events during decitabine maintenance
Investigations Aspartate aminotransferase increased	37.1% 49/132 • Number of events 110 132 participants were assessed for adverse events during decitabine maintenance
Investigations Blood bilirubin increased	12.1% 16/132 • Number of events 20 132 participants were assessed for adverse events during decitabine maintenance
Investigations Creatinine increased	8.3% 11/132 • Number of events 19 132 participants were assessed for adverse events during decitabine maintenance
Investigations Gamma-glutamyltransferase increased	1.5% 2/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Investigations INR increased	3.0% 4/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Investigations Laboratory test abnormal	10.6% 14/132 • Number of events 26 132 participants were assessed for adverse events during decitabine maintenance
Investigations Leukocyte count decreased	45.5% 60/132 • Number of events 257 132 participants were assessed for adverse events during decitabine maintenance
Investigations Lymphocyte count decreased	31.1% 41/132 • Number of events 147 132 participants were assessed for adverse events during decitabine maintenance
Investigations Neutrophil count decreased	96.2% 127/132 • Number of events 609 132 participants were assessed for adverse events during decitabine maintenance
Investigations Platelet count decreased	96.2% 127/132 • Number of events 604 132 participants were assessed for adverse events during decitabine maintenance
Investigations Serum cholesterol increased	0.76% 1/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Investigations Weight gain	5.3% 7/132 • Number of events 21 132 participants were assessed for adverse events during decitabine maintenance
Investigations Weight loss	3.8% 5/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Anorexia	14.4% 19/132 • Number of events 33 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Blood bicarbonate decreased	3.8% 5/132 • Number of events 12 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Blood glucose increased	43.2% 57/132 • Number of events 149 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Blood uric acid increased	4.5% 6/132 • Number of events 22 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Dehydration	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum albumin decreased	12.9% 17/132 • Number of events 27 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum calcium decreased	15.9% 21/132 • Number of events 33 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum calcium increased	3.0% 4/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum glucose decreased	3.8% 5/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum magnesium decreased	6.8% 9/132 • Number of events 22 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum phosphate decreased	6.1% 8/132 • Number of events 22 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum potassium decreased	16.7% 22/132 • Number of events 38 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum potassium increased	3.0% 4/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum sodium decreased	13.6% 18/132 • Number of events 29 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum sodium increased	2.3% 3/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Metabolism and nutrition disorders Serum triglycerides increased	0.76% 1/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 22/132 • Number of events 38 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Arthritis	1.5% 2/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Back pain	23.5% 31/132 • Number of events 71 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Bone pain	8.3% 11/132 • Number of events 21 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Buttock pain	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Chest wall pain	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Muscle weakness	3.0% 4/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	4.5% 6/132 • Number of events 13 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Myalgia	15.9% 21/132 • Number of events 38 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Neck pain	3.8% 5/132 • Number of events 9 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Osteoporosis	1.5% 2/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Musculoskeletal and connective tissue disorders Pain in extremity	18.9% 25/132 • Number of events 45 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Abducens nerve disorder	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Ataxia	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Dizziness	18.9% 25/132 • Number of events 39 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Dysgeusia	5.3% 7/132 • Number of events 12 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Extrapyramidal disorder	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Headache	29.5% 39/132 • Number of events 71 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Memory impairment	3.0% 4/132 • Number of events 10 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Neuralgia	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Neurological disorder NOS	3.0% 4/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Peripheral motor neuropathy	0.76% 1/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Peripheral sensory neuropathy	21.2% 28/132 • Number of events 63 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Recurrent laryngeal nerve palsy	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Sinus pain	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Speech disorder	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Syncope	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Nervous system disorders Tremor	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Psychiatric disorders Agitation	3.0% 4/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Psychiatric disorders Anxiety	23.5% 31/132 • Number of events 57 132 participants were assessed for adverse events during decitabine maintenance
Psychiatric disorders Confusion	3.0% 4/132 • Number of events 9 132 participants were assessed for adverse events during decitabine maintenance
Psychiatric disorders Depression	14.4% 19/132 • Number of events 43 132 participants were assessed for adverse events during decitabine maintenance
Psychiatric disorders Insomnia	19.7% 26/132 • Number of events 59 132 participants were assessed for adverse events during decitabine maintenance
Psychiatric disorders Libido decreased	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Psychiatric disorders Personality change	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Psychiatric disorders Psychosis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Renal and urinary disorders Bladder pain	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Renal and urinary disorders Cystitis	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Renal and urinary disorders Glomerular filtration rate decreased	0.76% 1/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Renal and urinary disorders Kidney pain	1.5% 2/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Renal and urinary disorders Urinary frequency	3.8% 5/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Renal and urinary disorders Urogenital disorder	2.3% 3/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Reproductive system and breast disorders Erectile dysfunction	0.76% 1/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Reproductive system and breast disorders Pelvic pain	1.5% 2/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance
Reproductive system and breast disorders Reproductive tract disorder	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Reproductive system and breast disorders Uterine pain	0.76% 1/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Reproductive system and breast disorders Vaginal hemorrhage	6.1% 8/132 • Number of events 13 132 participants were assessed for adverse events during decitabine maintenance
Reproductive system and breast disorders Vaginal pain	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	12.9% 17/132 • Number of events 31 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Cough	34.8% 46/132 • Number of events 68 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Dyspnea	25.8% 34/132 • Number of events 49 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Epistaxis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Hiccups	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Hypoxia	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.3% 7/132 • Number of events 9 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Pharyngeal stenosis	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	8.3% 11/132 • Number of events 16 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Respiratory disorder	5.3% 7/132 • Number of events 9 132 participants were assessed for adverse events during decitabine maintenance
Respiratory, thoracic and mediastinal disorders Respiratory tract hemorrhage	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Alopecia	3.8% 5/132 • Number of events 6 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Dry skin	3.0% 4/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	0.76% 1/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Nail disorder	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Pain of skin	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Petechiae	2.3% 3/132 • Number of events 3 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Photosensitivity	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Pruritus	7.6% 10/132 • Number of events 14 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Rash acneiform	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Rash desquamating	12.9% 17/132 • Number of events 30 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Skin disorder	9.1% 12/132 • Number of events 20 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Skin ulceration	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Skin and subcutaneous tissue disorders Sweating	9.1% 12/132 • Number of events 14 132 participants were assessed for adverse events during decitabine maintenance
Vascular disorders Flushing	1.5% 2/132 • Number of events 2 132 participants were assessed for adverse events during decitabine maintenance
Vascular disorders Hematoma	0.76% 1/132 • Number of events 1 132 participants were assessed for adverse events during decitabine maintenance
Vascular disorders Hot flashes	3.8% 5/132 • Number of events 5 132 participants were assessed for adverse events during decitabine maintenance
Vascular disorders Hypertension	10.6% 14/132 • Number of events 24 132 participants were assessed for adverse events during decitabine maintenance
Vascular disorders Hypotension	6.1% 8/132 • Number of events 8 132 participants were assessed for adverse events during decitabine maintenance
Vascular disorders Thrombosis	2.3% 3/132 • Number of events 4 132 participants were assessed for adverse events during decitabine maintenance

Additional Information

William Blum, M.D.

The Ohio State University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60