Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combin... | NCT02706899

Label	Type	Description	Intervention Names
33A + azacitidine	Experimental	Vadastuximab talirine plus azacitidine	Drug: vadastuximab talirine Drug: Azacitidine
Placebo + azacitidine	Active Comparator	placebo plus azacitidine	Drug: Azacitidine Drug: Placebo (for 33A)

Name	Type	Description	Arm Group Labels	Other Names
vadastuximab talirine	Drug	Intravenous (IV) push every 4 weeks	33A + azacitidine

Measure	Description	Time Frame
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study	A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.	Up to 1 year
Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study		N/A - End point not assessed

Measure	Description	Time Frame
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities	As defined by the number of participants with adverse events and laboratory abnormalities. Participants are included only once per row, even if the participant experienced multiple events applicable to the category.	Up to 1 year

Name	Affiliation	Role
Phillip Garfin	Seagen Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson Cancer Center		Gilbert	Arizona		United States
University of Southern California

ID	Title	Description
FG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
FG001	33A (10 mcg/kg) + Azacitidine

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 13, 2017	Oct 15, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study

A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.

Posted

Number

Number of doses

Up to 1 year

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG00013 OG0016

Title

Denominators

Categories

Vadastuximab talirine doses delayed

Title	Measurements
	OG0002 OG0010

Vadastuximab talirine dosed reduced

Title	Measurements
	OG000

Primary

Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study

No patients were assessed for this outcomes as the study did not progress to Phase 2.

Posted

N/A - End point not assessed

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG000

Secondary

Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities

As defined by the number of participants with adverse events and laboratory abnormalities. Participants are included only once per row, even if the participant experienced multiple events applicable to the category.

Posted

Count of Participants

Participants

Up to 1 year

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG000

Secondary

Complete Response Rate (CR)

Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the CR rate, as defined by the 2006 IWG criteria for MDS.

No patients were assessed for this outcomes as the study did not progress to Phase 2.

Posted

N/A - End point not assessed

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG000

Secondary

Hematologic Improvement (HI) Rate

Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the HI rate, as defined by the 2006 IWG criteria for MDS.

No patients were assessed for this outcomes as the study did not progress to Phase 2.

Posted

N/A - End point not assessed

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG000

Secondary

Duration of Response (DOR) Rate

Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first observation of response (CR, PR, or Marrow CR) to disease progression/relapse or death from any cause, whichever occurs first.

No patients were assessed for this outcomes as the study did not progress to Phase 2.

Posted

N/A - End point not assessed

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG000

Secondary

Progression Free Survival (PFS)

Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.

No patients were assessed for this outcomes as the study did not progress to Phase 2.

Posted

N/A - End point not assessed

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG000

Secondary

Rate of Transformation to Acute Myeloid Leukemia (AML)

Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the rate of transformation to AML after initiation of study therapy.

No patients were assessed for this outcomes as the study did not progress to Phase 2.

Posted

N/A - End point not assessed

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to death due to any cause.

No patients were assessed for this outcomes as the study did not progress to Phase 2.

Posted

N/A - End point not assessed

ID	Title	Description
OG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
OG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0008 affected13 at risk EG0014 affected6 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected13 at risk EG0014 affected6 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0013 affected6 at risk
Oral pain	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected13 at risk EG0011 affected6 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0012 affected6 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0011 affected6 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0010 affected6 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0010 affected6 at risk
Glossodynia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected13 at risk EG0014 affected6 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected13 at risk EG0010 affected6 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected13 at risk EG0010 affected6 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Fatigue	General disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected13 at risk EG0013 affected6 at risk
Pyrexia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected13 at risk EG0012 affected6 at risk
Chills	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0013 affected6 at risk
Asthenia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Catheter site rash	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Chest discomfort	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Face oedema	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Injection site erythema	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Injection site rash	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Injection site reaction	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Localised oedema	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Malaise	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Oedema peripheral	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Peripheral swelling	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected13 at risk EG0011 affected6 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected13 at risk EG0012 affected6 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected13 at risk EG0011 affected6 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0013 affected6 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0010 affected6 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Headache	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected13 at risk EG0013 affected6 at risk
Dizziness	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected13 at risk EG0013 affected6 at risk
Dysgeusia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0010 affected6 at risk
Presyncope	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0012 affected6 at risk
Intercranial aneurysm	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Sinus headache	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Syncope	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Tremor	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Neutrophil count decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0013 affected6 at risk
Platelet count decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0015 affected6 at risk
White blood cell count decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0014 affected6 at risk
Blood bilirubin increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0012 affected6 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Blood creatinine increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0010 affected6 at risk
Alanine aminotransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Amylase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Blood urea increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Heart rate irregular	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Intraocular pressure increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Lipase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Lymphocyte count decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Protein total decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected13 at risk EG0011 affected6 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected13 at risk EG0011 affected6 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0011 affected6 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0011 affected6 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0011 affected6 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0010 affected6 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Pneumonia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected13 at risk EG0010 affected6 at risk
Rash pustular	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0012 affected6 at risk
Folliculitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Cellulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Mucosal infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Nail infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Parotitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Skin candida	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Soft tissue infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Vulvitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0012 affected6 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Vision blurred	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0011 affected6 at risk
Cataract	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Corneal opacity	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Photophobia	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Insomnia	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected13 at risk EG0011 affected6 at risk
Anxiety	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Confusional state	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Hallucination	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Haematuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hypertension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk
Hypotension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected6 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected6 at risk

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

ID	Title	Description
BG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
BG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	33A (5 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks	8	13	9	13	13	13
EG001	33A (10 mcg/kg) + Azacitidine	Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks	0	6	4	6	6	6