Trial Outcomes & Findings for An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS) (NCT NCT01186939)

Last Updated: 2019-11-14

Results Overview

Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

43- 68 months

Results posted on

2019-11-14

Participant Flow

Participants were eligible for the extension study of AZA PH GL 2003 CL 001 if they had been randomized to azacitidine treatment in the primary study and receiving azacitidine at the time of study closure, completed 12 months of treatment and observation in the primary study, and signed the informed consent document for the extension study.

Participant milestones

Participant milestones
Measure	Azacitidine Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m\^2/day.
Overall Study STARTED	40
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Azacitidine Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m\^2/day.
Overall Study Death	7
Overall Study Withdrawal by Subject	2
Overall Study No longer receiving clinical benefit	17
Overall Study Program closed	5
Overall Study Sponsor decision	4
Overall Study Started additional treatment	1
Overall Study NCI CTC Grade 3 or 4 toxicity	1
Overall Study Myocardial infarction	1
Overall Study Bone marrow transplant	1
Overall Study Transformation to AML	1

Baseline Characteristics

An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azacitidine n=40 Participants Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m\^2/day.
Age, Continuous	68.6 years STANDARD_DEVIATION 8.23 • n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	32 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	40 participants n=93 Participants
French-American-British (FAB) Classification Refractory anemia with excess blasts (RAEB)	27 participants n=93 Participants
French-American-British (FAB) Classification RAEB in transformation	10 participants n=93 Participants
French-American-British (FAB) Classification Modified chronic myelomonocytic leukemia	1 participants n=93 Participants
French-American-British (FAB) Classification Acute myeloid leukemia	1 participants n=93 Participants
French-American-British (FAB) Classification Myeloproliferative disease	1 participants n=93 Participants
World Health Organization (WHO) Classification Refractory anemia with excess blasts - 1	5 participants n=93 Participants
World Health Organization (WHO) Classification Refractory anemia with excess blasts - 2	22 participants n=93 Participants
World Health Organization (WHO) Classification Chronic myelomonocytic leukemia - 1 (CMMoL-1)	0 participants n=93 Participants
World Health Organization (WHO) Classification Chronic myelomonocytic leukemia - 2 (CMMoL-2)	2 participants n=93 Participants
World Health Organization (WHO) Classification Acute myeloid leukemia	11 participants n=93 Participants
International Prognostic Scoring System (IPSS) Intermediate risk level 1 (0.5-1.0)	1 participants n=93 Participants
International Prognostic Scoring System (IPSS) Intermediate risk level 2 (1.5-2.0)	21 participants n=93 Participants
International Prognostic Scoring System (IPSS) High risk (2.5-3.5)	14 participants n=93 Participants
International Prognostic Scoring System (IPSS) Not applicable	2 participants n=93 Participants
International Prognostic Scoring System (IPSS) Indeterminate	2 participants n=93 Participants

PRIMARY outcome

Timeframe: 43- 68 months

Population: Safety population includes all 40 participants in the extension study.

Outcome measures

Outcome measures
Measure	Azacitidine n=40 Participants Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m\^2/day.
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period Participants with >=1 treatment emergent AE (TEAE)	39 participants
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period Participants with >=1 treatment related TEAE	27 participants
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period Participants with >=1 serious TEAE	20 participants
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period Participants with >=1 serious trtment related TEAE	5 participants
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period Participants w TEAE leading to discontinued treat	15 participants
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period Participants w TEAE leading to dose reduction	4 participants
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period Participants w TEAE leading to dose interruption	15 participants

Adverse Events

Azacitidine

Serious events: 20 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Azacitidine n=40 participants at risk Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m\^2/day.
Blood and lymphatic system disorders Anaemia	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Blood and lymphatic system disorders Febrile neutropenia	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Blood and lymphatic system disorders Thrombocytopenia	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Cardiac disorders Acute myocardial infarction	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Cardiac disorders Angina pectoris	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Cardiac disorders Cardiac arrest	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Cardiac disorders Cardiac failure	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Cardiac disorders Cardiac failure congestive	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Cardiac disorders Cardiac tamponade	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Cardiac disorders Myocardial infarction	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Gastrointestinal disorders Melaena	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Gastrointestinal disorders Subileus	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
General disorders General physical health deterioration	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
General disorders Pyrexia	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Injection site infection	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Localised infection	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Lower respiratory tract infection	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Perianal abscess	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Pneumonia	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Sepsis	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Septic shock	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Injury, poisoning and procedural complications Transfusion reaction	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Investigations White blood cell count increase	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	10.0% 4/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Psychiatric disorders Mental disorder due to a general medical condition	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Renal and urinary disorders Renal artery stenosis	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Vascular disorders Cardiovascular insufficiency	2.5% 1/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.

Other adverse events

Other adverse events
Measure	Azacitidine n=40 participants at risk Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m\^2/day.
Blood and lymphatic system disorders Anaemia	27.5% 11/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Blood and lymphatic system disorders Leukopenia	10.0% 4/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Blood and lymphatic system disorders Neutropenia	32.5% 13/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Blood and lymphatic system disorders Thrombocytopenia	42.5% 17/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Gastrointestinal disorders Abdominal pain	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Gastrointestinal disorders Constipation	10.0% 4/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Gastrointestinal disorders Diarrhoea	25.0% 10/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Gastrointestinal disorders Nausea	15.0% 6/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Gastrointestinal disorders Vomiting	10.0% 4/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
General disorders Asthenia	10.0% 4/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
General disorders Fatigue	15.0% 6/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
General disorders Injection site erythema	10.0% 4/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
General disorders Injection site reaction	20.0% 8/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
General disorders Oedema peripheral	12.5% 5/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
General disorders Pyrexia	17.5% 7/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Bronchitis	7.5% 3/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Cellulitis	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Gastroenteritis	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Herpes virus infection	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Influenza	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Lower respiratory tract infection	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Nasopharyngitis	12.5% 5/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Oral herpes	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Sinusitis	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Infections and infestations Upper respiratory tract infection	7.5% 3/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Injury, poisoning and procedural complications Contusion	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Injury, poisoning and procedural complications Fall	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Musculoskeletal and connective tissue disorders Back pain	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Musculoskeletal and connective tissue disorders Bone pain	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Psychiatric disorders Depression	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 4/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	7.5% 3/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Respiratory, thoracic and mediastinal disorders Productive cough	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Skin and subcutaneous tissue disorders Blood blister	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Skin and subcutaneous tissue disorders Dermal cyst	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Skin and subcutaneous tissue disorders Ecchmyosis	7.5% 3/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Skin and subcutaneous tissue disorders Petechiae	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Vascular disorders Haematoma	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 2/40 • Extension study covering 43- 68 months Includes adverse events that started up to 42 days after the date of last dose of azacitidine in the extension study. Also any adverse event that started outside the treatment-emergent periods and assessed as related to study drug is considered treatment emergent.

Additional Information

CL Beach

Celgene Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
Publication restrictions are in place

Restriction type: OTHER