NCT01522976 · OUTCOME

Toxicity Rate

Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia · Source last updated 2026-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 5 years

What was measured

Adverse events that are possibly, probably or definitely related to study drug are reported.

Analysis population: Analysis includes only eligible patients who also received treatment.

Groups in this outcome

Arm 1: Azacitidine/Lenalidomide

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV

Arm 2: Azacitidine

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV

Arm 3: Azacitidine/Vorinostat

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Arm 1: Azacitidine/Lenalidomide	89
Arm 2: Azacitidine	91
Arm 3: Azacitidine/Vorinostat	91

Reported measurements

Abdominal infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Acute kidney injury

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Adult respiratory distress syndrome

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	5	Not reported	Not reported	Not reported	Not reported

Anemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	48	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	37	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	44	Not reported	Not reported	Not reported	Not reported

Anorectal infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	4	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Apnea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Ascites

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Ataxia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Back pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Blood and lymphatic system disorders - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	2	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Bronchial infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

CD4 lymphocytes decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Cardiac arrest

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Catheter related infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	2	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Cecal infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Cholecystitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Colitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Confusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	2	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Creatinine increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	2	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	5	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Delirium

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	5	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Dizziness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Dyspnea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	4	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	2	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Epistaxis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Esophageal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Esophagitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Fall

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	9	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	6	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	14	Not reported	Not reported	Not reported	Not reported

Febrile neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	16	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	11	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	13	Not reported	Not reported	Not reported	Not reported

Fever

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Flushing

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Gastric hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Gastrointestinal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

General disorders and admin site conditions-Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Generalized muscle weakness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	3	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Hallucinations

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Heart failure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Hematoma

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Hematuria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Hyperglycemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Hypernatremia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Hyperuricemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	3	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Hypokalemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	4	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	5	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	4	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	4	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Hypoxia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Infections and infestations - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	4	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	2	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	5	Not reported	Not reported	Not reported	Not reported

Intracranial hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Investigations - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Leukocytosis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Lower gastrointestinal hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Lung infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	4	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Lymphocyte count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	14	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	9	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Lymphocyte count increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Mucosal infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Mucositis oral

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	2	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	69	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	48	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	63	Not reported	Not reported	Not reported	Not reported

Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Papulopustular rash

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Pericardial effusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	61	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	46	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	64	Not reported	Not reported	Not reported	Not reported

Pneumonitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Pruritus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Pulmonary edema

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Purpura

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Rash maculo-papular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	13	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	3	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Renal and urinary disorders - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Respiratory failure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Sepsis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	4	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	2	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	3	Not reported	Not reported	Not reported	Not reported

Sinus bradycardia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Skin infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	3	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	2	Not reported	Not reported	Not reported	Not reported

Soft tissue infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Sudden death NOS

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Syncope

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	2	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	4	Not reported	Not reported	Not reported	Not reported

Thromboembolic event

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Tooth infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Upper gastrointestinal hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Upper respiratory infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

Urinary tract infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Vascular disorders - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	0	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	1	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	1	Not reported	Not reported	Not reported	Not reported

Weight loss

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	1	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	0	Not reported	Not reported	Not reported	Not reported

White blood cell decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Azacitidine/Lenalidomide	48	Not reported	Not reported	Not reported	Not reported
Arm 2: Azacitidine	34	Not reported	Not reported	Not reported	Not reported
Arm 3: Azacitidine/Vorinostat	44	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Abdominal infection
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
3
title
Abdominal pain
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Acute kidney injury
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
Adult respiratory distress syndrome
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
5
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
48
group Id
OG001
value
37
group Id
OG002
value
44
title
Anemia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Anorectal infection
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
3
title
Anorexia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Apnea
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
title
Ascites
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
3
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Ataxia

denoms

counts
group Id
OG000
value
89
group Id
OG001
value
91
group Id
OG002
value
91
units
Participants

description

Adverse events that are possibly, probably or definitely related to study drug are reported.

groups

description
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
id
OG000
title
Arm 1: Azacitidine/Lenalidomide
description
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
id
OG001
title
Arm 2: Azacitidine
description
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
id
OG002
title
Arm 3: Azacitidine/Vorinostat

param Type

NUMBER

population Description

Analysis includes only eligible patients who also received treatment.

reporting Status

POSTED

time Frame

Up to 5 years

title

Toxicity Rate

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice