SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

Sponsor

Astex Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02348489

Collaborator

(none)

815

Enrollment

135

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute	Drug: SGI-110 (guadecitabine) Drug: Treatment Choice	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

815 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

Actual Study Start Date :

Mar 19, 2015

Actual Primary Completion Date :

May 31, 2018

Actual Study Completion Date :

Jun 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGI-110 (guadecitabine) Guadecitabine 60 mg/m^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	Drug: SGI-110 (guadecitabine) Investigational medicinal product
Active Comparator: Treatment Choice One of the following treatment regimens: 20 mg cytarabine administered subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.	Drug: Treatment Choice Choice of one: cytarabine, decitabine, or azacitidine

Arm

Intervention/Treatment

Experimental: SGI-110 (guadecitabine)

Guadecitabine 60 mg/m^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.

Drug: SGI-110 (guadecitabine)

Investigational medicinal product

Active Comparator: Treatment Choice

One of the following treatment regimens: 20 mg cytarabine administered subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.

Drug: Treatment Choice

Choice of one: cytarabine, decitabine, or azacitidine

Outcome Measures

Primary Outcome Measures

Number of Participants With a Complete Response (CR) [Up to 38 months (median follow-up of 25.5 months)]
Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.
Overall Survival [At 676 death events (up to 38 months)]
Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause.

Secondary Outcome Measures

Number of Participants With Composite CR (CRc) [Up to 38 months (median follow-up of 25.5 months)]
CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi).
Number of Days Alive and Out of the Hospital [Month 6]
The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The Number of Days Alive and Out of the Hospital (NDAOH) was calculated as: NDAOH=180 - total duration of all hospital stays within 180 days from the first treatment - number of death days before Day 180. For subjects who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the subject would have died the day after the last contact day.
Progression-free Survival (PFS) [Up to 38 months (median follow-up of 25.5 months)]
Progression-free survival was defined as the number of days from randomization to the earliest date of investigator's assessment of disease progression, participant receiving an alternative anti-leukemia therapy (including hematopoietic cell transplant), or relapse by peripheral blood (PB) assessment or blinded bone marrow (BM) assessment, whichever occurred first, or death, regardless of cause.
Number of Red Blood Cell or Platelet Transfusions [Month 6]
The total number of red blood cells (RBCs) transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit.
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L [Baseline to Month 6]
EuroQol 5-level 5-dimension (EQ-5D-5L) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. Scores within each dimension for EQ-5D (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) were calculated using counts and proportions. Mean change in scores from baseline are summarized in which an index score of 0 represents the worst health state and 1 represents the best health state.
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS [Baseline to Month 6]
EuroQol-Visual Analogue Scale (EQ-VAS) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. A vertical 20-cm scale for EQ-VAS was used where the lowest value of 0 was labeled "the worst health you can imagine" and the top value of 100 was labeled "the best health you can imagine." Mean change in scores from baseline are summarized.
Duration of CR [Up to 38 months (median follow-up of 25.5 months)]
Duration of CR (in number of days) was calculated from the first time a CR was observed to the time of relapse, defined as the earliest time point whereby BM assessment or PB assessment indicated relapse/disease progression due to reappearance of leukemic blasts in PB or ≥ 5% leukemic blasts in BM.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to World Health Organization (WHO) classification.

Performance status (ECOG) of 0-3. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed.

Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:

≥75 years of age OR
<75 years of age with at least 1 of the following:

Poor performance status (ECOG) score of 2-3.

Clinically significant heart or lung comorbidities, as reflected by at least 1 of:

Left ventricular ejection fraction (LVEF) ≤50%.
Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.
Forced expiratory volume in 1 second (FEV1) ≤65% of expected.
Chronic stable angina or congestive heart failure controlled with medication.

Liver transaminases >3 × upper limit of normal (ULN).
Other contraindication(s) to anthracycline therapy (must be documented).
Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization.

Creatinine clearance as estimated by the Cockcroft-Gault (C-G) or other medically acceptable formulas ≥30 mL/min.

Exclusion Criteria:

Candidate for intensive remission induction chemotherapy at the time of enrollment.

Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators.

Known extramedullary central nervous system (CNS) AML.

Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.

Prior treatment with decitabine or azacitidine.

Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.

Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed.

Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.

Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring >2 liters per minute (LPM) oxygen.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Cancer Center	Scottsdale	Arizona	United States	85259-5499
2	Scripps Cancer Center	La Jolla	California	United States
3	University of Southern California	Los Angeles	California	United States	90033
4	University of Chicago	Chicago	Illinois	United States	60637
5	University of Kansas Medical Center	Westwood	Kansas	United States	66160
6	University of Minnesota Medical Center	Minneapolis	Minnesota	United States	55454
7	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
8	John Theurer Cancer Center at Hackensack	Hackensack	New Jersey	United States	07601
9	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131
10	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
11	Weill Cornell Medical College	New York	New York	United States	10021
12	Columbia University Medical Center	New York	New York	United States	10065
13	Stony Brook University Medical Center	Stony Brook	New York	United States	11790
14	Duke Cancer Center	Durham	North Carolina	United States
15	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
16	University Hospitals Monarch Medical Center	Cleveland	Ohio	United States
17	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
18	Temple University	Philadelphia	Pennsylvania	United States	19111
19	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
20	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
21	MD Anderson Cancer Center	Houston	Texas	United States	77030
22	University of Wisconsin	Madison	Wisconsin	United States	53792
23	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
24	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
25	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
26	Monash Medical Centre	Clayton	Victoria	Australia	3168
27	Austin Health	Heidelberg	Victoria	Australia
28	Medizinische Universität Graz	Graz	Styria	Austria
29	Hanusch Krankenhaus Wiener Gebietskrankenkasse	Wien	Vienna	Austria
30	Grand Hôpital de Charleroi	Charleroi	Hainaut	Belgium	6061
31	UZ Gent	Ghent	Oost-vlaanderen	Belgium	9000
32	Algemeen Ziekenhuis Sint-Jan	Brugge	West-vlaanderen	Belgium	8000
33	UMHAT 'Sveti Georgi' EAD	Plovdiv		Bulgaria
34	Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD	Varna		Bulgaria
35	Tom Baker Cancer Center	Calgary	Alberta	Canada	T2N 4N2
36	University of Alberta Hospital	Edmonton	Alberta	Canada	76B 2B7
37	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
38	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
39	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
40	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada
41	Fakultní nemocnice Brno	Brno	Jihormoravsky KRAJ	Czechia
42	Všeobecná fakultní nemocnice v Praze	Praha 2	Praha	Czechia
43	Fakultní nemocnice Královské Vinohrady	Praha 10		Czechia	Praha 10
44	Aarhus University Hospital	Aarhus		Denmark	8000
45	Rigshospitalet-Copenhagen University Hospital	Copenhagen		Denmark
46	Odense University Hospital	Odense		Denmark
47	Tampere University Hospital	Tampere	Southern Finland	Finland
48	Helsinki University Central Hospital	Helsinki		Finland
49	GHR Mulhouse Sud-Alsace	Mulhouse Cedex	Alsace	France
50	Hôpital Hôtel-Dieu	Bayonne	Aquitaine	France
51	Centre Henri-Becquerel	Rouen Cedex 1	Haute-normandie	France
52	Hôpital Saint Louis	Paris Cedex 10	Ile-de-france	France	75010
53	CHRU de Limoges - Hôpital Dupuytren	Limoges Cedex	Limousin, Lorraine	France	87000
54	Centre Hospitalier Universitaire de Toulouse	Toulouse cedex 9	Midi-pyrenees	France
55	Hôpital Hôtel-Dieu	Nantes cedex 1	PAYS DE LA Loire	France
56	Institut Paoli Calmettes	Marseille Cedex 9	Provence Alpes COTE D'azur	France
57	Centre Antoine Lacassagne	Nice	Provence Alpes COTE D'azur	France
58	Centre Hospitalier Universitaire Grenoble	La Tronche	Rhone-alpes	France	38700
59	Centre Léon Bérard	Lyon Cedex 08	Rhone-alpes	France
60	Centre Hospitalier Lyon Sud	Pierre Bénite Cedex	Rhone-alpes	France
61	Universitaetsklinikum Freiburg	Freiburg	Baden-wuerttemberg	Germany
62	Universitätsklinikum Ulm	Ulm	Baden-wuerttemberg	Germany
63	Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	Baden-wuerttemberg	Germany
64	Universitätsklinikum Frankfurt Goethe Universität	Frankfurt am Main	Hessen	Germany
65	Städtisches Klinikum Braunschweig gGmbH	Braunschweig	Niedersachsen	Germany	38114
66	Marien Hospital Düsseldorf GmbH	Düsseldorf	Nordrhein-westfalen	Germany
67	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-holstein	Germany
68	Bacs-Kiskun Megyei Korhaz	Kecskemét	Bacs-kiskun	Hungary
69	Semmelweis Egyetem	Budapest		Hungary	1085
70	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
71	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár		Hungary	7400
72	Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro	Pesaro E Urbino	Italy
73	IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture	Rionero in Vulture	Potenza	Italy
74	Azienda Ospedaliero-Univesitaria San Luigi Gonzaga	Orbassano	Torino	Italy
75	Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria	Alessandria		Italy
76	Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi	Bologna		Italy
77	Azienda Ospedaliera Ospedale di Busto Arsizio	Busto Arsizio		Italy	21052
78	Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino	Catania		Italy
79	IRCCS Azienda Ospedaliera Universitaria San Martino - IST	Genova		Italy
80	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano		Italy
81	Azienda Ospedaliero-Universitaria Policlinico di Modena	Modena		Italy
82	AORN A. Cardarelli	Napoli		Italy
83	Azienda Policlinico Umberto I di Roma	Roma		Italy
84	Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine	Udine		Italy
85		Chubu		Japan
86		Chugoku		Japan
87		Kanto		Japan
88		Kinki		Japan
89		Kyushu		Japan
90		Tohoku		Japan
91	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of
92	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do	Korea, Republic of
93	Seoul National University Hospital	Jongno Gu	Seoul	Korea, Republic of
94	Inje University Busan Paik Hospital	Busan		Korea, Republic of
95	Kyungpook National University Hospital	Daegu		Korea, Republic of
96	Asan Medical Center	Seoul		Korea, Republic of
97	Samsung Medical Center	Seoul		Korea, Republic of
98	Seoul Saint Mary's Hospital	Seoul		Korea, Republic of
99	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of
100	Ulsan University Hospital	Ulsan		Korea, Republic of
101	Universitair Medisch Centrum Utrecht	Utrecht		Netherlands
102	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu	Wroclaw	Dolnoslaskie	Poland
103	Wojewodzki Szpital Specjalistyczny im. M. Kopernika	Lódz	Lodzkie	Poland
104	Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie	Lublin	Lubelskie	Poland
105	Instytut Hematologii i Transfuzjologii	Warszawa	Mazowieckie	Poland
106	Samodzielny Publiczny Centralny Szpital Kliniczny	Warszawa	Mazowieckie	Poland
107	Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Opole	Opolskie	Poland
108	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich	Chorzów	Slaskie	Poland
109	Spitalul Clinic Judetean de Urgenta Tirgu-Mures	Targu-Mures	Mures	Romania
110	Institutul Regional de Oncologie Iasi	Iasi		Romania
111	Sverdlovsk Regional Clinical Hospital #1	Ekaterinburg		Russian Federation
112	Ryazan Regional Clinical Hospital	Ryazan		Russian Federation
113	Saratov State Medical University	Saratov		Russian Federation
114	Clinical Center of Serbia	Belgrade		Serbia
115	Clinical Centre of Vojvodina	Novi Sad		Serbia
116	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain
117	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona	Spain
118	Hospital Vall d´Hebrón	Barcelona		Spain
119	Hospital San Pedro de Alcantara	Caceres		Spain
120	Hospital General Virgen de las Nieves	Granada		Spain
121	Hospital General Universitario Gregorio Marañon	Madrid		Spain
122	Hospital Universitario 12 de Octubre	Madrid		Spain
123	Hospital Clínico Universitario de Salamanca	Salamanca		Spain
124	Hospital Universitario Virgen del Rocio	Sevilla		Spain
125	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain	46026
126	Skånes Universitetssjukhus i Lund	Lund	Skane	Sweden
127	Karolinska University Hospital Huddinge	Stockholm		Sweden
128	Chang Gung Medical Foundation-LinKou Branch	Tao-Yuan	Taoyuan	Taiwan
129	China Medical University Hospital	Taichung		Taiwan
130	Mackay Memorial Hospital	Taipei		Taiwan
131	National Taiwan University Hospital	Taipei		Taiwan
132	Taipei Veterans General Hospital	Taipei		Taiwan
133	Chelsea and Westminster Hospital NHS Foundation Trust	London	England	United Kingdom
134	King's College Hospital	London	England	United Kingdom
135	Medway Maritime Hospital	Gillingham	Kent	United Kingdom

Sponsors and Collaborators

Astex Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Astex Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT02348489

Other Study ID Numbers:

SGI-110-04

First Posted:

Jan 28, 2015

Last Update Posted:

Jan 14, 2021

Last Verified:

Dec 1, 2020

Keywords provided by Astex Pharmaceuticals, Inc.

AML

Acute Myeloid Leukemia

SGI-110

DNA Hypomethylating Agen

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Guadecitabine

Study Results

Participant Flow

Recruitment Details

A total of 949 participants were assessed for inclusion in the study. Of these, 134 participants failed screening assessments and 815 participants were randomized.

Pre-assignment Detail

For the efficacy analysis (all randomized participants), the total duration was 38 months, with a median follow-up of 766 days (25.5 months), lower quartile follow-up of 671 days (22.4 months), and upper quartile follow-up of 896 days (29.9 months). For safety analysis (all treated participants), total duration was 51 months. Combining participants into a single group as part of the Treatment Choice arm was pre-specified as part of the study design.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Period Title: Overall Study
STARTED	408	407
COMPLETED	55	40
NOT COMPLETED	353	367

Baseline Characteristics

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice	Total
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.	Total of all reporting groups
Overall Participants	408	407	815
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.9 (6.2)	75.9 (5.8)	75.9 (6.0)
Sex: Female, Male (Count of Participants)
Female	177 43.4%	165 40.5%	342 42%
Male	231 56.6%	242 59.5%	473 58%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 3.7%	14 3.4%	29 3.6%
Not Hispanic or Latino	365 89.5%	345 84.8%	710 87.1%
Unknown or Not Reported	28 6.9%	48 11.8%	76 9.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.2%	1 0.1%
Asian	71 17.4%	74 18.2%	145 17.8%
Native Hawaiian or Other Pacific Islander	2 0.5%	0 0%	2 0.2%
Black or African American	9 2.2%	5 1.2%	14 1.7%
White	311 76.2%	291 71.5%	602 73.9%
More than one race	0 0%	1 0.2%	1 0.1%
Unknown or Not Reported	15 3.7%	35 8.6%	50 6.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Complete Response (CR)
Description	Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.
Time Frame	Up to 38 months (median follow-up of 25.5 months)

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	408	407
Count of Participants [Participants]	79 19.4%	71 17.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SGI-110 (Guadecitabine), Treatment Choice
	Comments	The complete response rate was compared between the treatment groups using a Cochran Mantel-Haenszel (CMH) test at an alpha level of 0.04 stratified to adjust for stratification factors used at randomization: age (<75 or >=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.482
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Method of Estimation	Estimation Parameter	Difference in response rate (%)
	Estimated Value	1.92
	Confidence Interval	(2-Sided) 96% -3.67 to 7.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Overall Survival
Description	Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause.
Time Frame	At 676 death events (up to 38 months)

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	408	407
Median (95% Confidence Interval) [days]	213	254

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SGI-110 (Guadecitabine), Treatment Choice
	Comments	Overall survival curves were estimated using Kaplan-Meier method and compared between the treatment groups using a 2-sided stratification log-rank test, stratified by the same factors used at randomization: age (<75 or >=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.7328
	Comments
	Method	Stratified log-rank
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95% 0.83 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With Composite CR (CRc)
Description	CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi).
Time Frame	Up to 38 months (median follow-up of 25.5 months)

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	408	407
Count of Participants [Participants]	93 22.8%	91 22.4%

4. Secondary Outcome

Title	Number of Days Alive and Out of the Hospital
Description	The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The Number of Days Alive and Out of the Hospital (NDAOH) was calculated as: NDAOH=180 - total duration of all hospital stays within 180 days from the first treatment - number of death days before Day 180. For subjects who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the subject would have died the day after the last contact day.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	408	407
Mean (Standard Deviation) [days]	98.1 (63.6)	105.7 (63.58)

5. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	Progression-free survival was defined as the number of days from randomization to the earliest date of investigator's assessment of disease progression, participant receiving an alternative anti-leukemia therapy (including hematopoietic cell transplant), or relapse by peripheral blood (PB) assessment or blinded bone marrow (BM) assessment, whichever occurred first, or death, regardless of cause.
Time Frame	Up to 38 months (median follow-up of 25.5 months)

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	408	407
Median (95% Confidence Interval) [days]	159	166

6. Secondary Outcome

Title	Number of Red Blood Cell or Platelet Transfusions
Description	The total number of red blood cells (RBCs) transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	408	407
Red Blood Cell Transfusions	16.2 (11.84)	15.6 (13.02)
Platelet Transfusions	12.5 (18.78)	14.4 (39.10)

7. Secondary Outcome

Title	Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L
Description	EuroQol 5-level 5-dimension (EQ-5D-5L) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. Scores within each dimension for EQ-5D (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) were calculated using counts and proportions. Mean change in scores from baseline are summarized in which an index score of 0 represents the worst health state and 1 represents the best health state.
Time Frame	Baseline to Month 6

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	391	378
Baseline	0.7767 (0.2160)	0.7663 (0.2291)
Month 6	0.8252 (0.1825)	0.8240 (0.1948)
Change from Baseline	-0.0023 (0.1830)	0.0112 (0.2325)

8. Secondary Outcome

Title	Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS
Description	EuroQol-Visual Analogue Scale (EQ-VAS) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. A vertical 20-cm scale for EQ-VAS was used where the lowest value of 0 was labeled "the worst health you can imagine" and the top value of 100 was labeled "the best health you can imagine." Mean change in scores from baseline are summarized.
Time Frame	Baseline to Month 6

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	391	377
Baseline	64.64 (21.69)	63.58 (21.05)
Month 6	72.76 (18.61)	71.72 (18.88)
Change from Baseline	3.28 (19.35)	3.67 (22.16)

9. Secondary Outcome

Title	Duration of CR
Description	Duration of CR (in number of days) was calculated from the first time a CR was observed to the time of relapse, defined as the earliest time point whereby BM assessment or PB assessment indicated relapse/disease progression due to reappearance of leukemic blasts in PB or ≥ 5% leukemic blasts in BM.
Time Frame	Up to 38 months (median follow-up of 25.5 months)

Outcome Measure Data

Analysis Population Description
The efficacy analysis set includes all randomized participants.

Arm/Group Title	SGI-110 (Guadecitabine)	Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.	One of the following treatment regimens was administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Measure Participants	408	407
Median (95% Confidence Interval) [days]	217	231

Adverse Events

	SGI-110 (Guadecitabine)		Treatment Choice
Time Frame	Up to 51 months. Median (range) duration of treatment was 5 cycles (1-42) for SGI-110 and 5 cycles (1-37) for Treatment Choice (28 days per cycle). Treatment-emergent adverse events were events that first occurred or worsened after the first dose of study treatment until 30 days after the last dose or start of an alternative anti-leukemia treatment, whichever occurred first.
Adverse Event Reporting Description	Safety analysis set (randomized participants who received study treatment) was analyzed for TEAEs. All-cause mortality is presented for all randomized participants (participant flow shows number of deaths with primary reason for study withdrawal). Combining participants into a single group (Treatment Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Death is listed as an SAE when there is no identifiable cause or event.

Arm/Group Title	SGI-110 (Guadecitabine)		Treatment Choice
Arm/Group Description	Guadecitabine 60 mg/m^2 was administered subcutaneously daily for 5 days (Days 1-5) in 28-day cycles.		One of the following treatment regimens were administered: 20 mg cytarabine subcutaneously (SC) BID on Days 1-10 every 28 days; 20 mg/m^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	341/408 (83.6%)		344/407 (84.5%)
Serious Adverse Events
	SGI-110 (Guadecitabine)		Treatment Choice
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	327/401 (81.5%)		297/392 (75.8%)
Blood and lymphatic system disorders
Agranulocytosis	1/401 (0.2%)	1	1/392 (0.3%)	1
Anemia	1/401 (0.2%)	1	1/392 (0.3%)	1
Disseminated intravascular coagulation	2/401 (0.5%)	2	0/392 (0%)	0
Febrile bone marrow aplasia	3/401 (0.7%)	3	4/392 (1%)	4
Febrile neutropenia	101/401 (25.2%)	147	88/392 (22.4%)	138
Hemorrhagic diathesis	2/401 (0.5%)	3	0/392 (0%)	0
Histiocytosis hematophagic	1/401 (0.2%)	1	0/392 (0%)	0
Leukocytosis	6/401 (1.5%)	7	2/392 (0.5%)	2
Lymphoadenopathy	1/401 (0.2%)	1	0/392 (0%)	0
Lymphoadenopathy mediastinal	0/401 (0%)	0	1/392 (0.3%)	1
Monoclonal B-cell lymphocytosis	1/401 (0.2%)	1	0/392 (0%)	0
Neutropenia	2/401 (0.5%)	2	2/392 (0.5%)	2
Pancytopenia	2/401 (0.5%)	2	1/392 (0.3%)	1
Splenic infarction	0/401 (0%)	0	2/392 (0.5%)	2
Thrombocytopenia	15/401 (3.7%)	15	5/392 (1.3%)	5
Cardiac disorders
Acute coronary syndrome	3/401 (0.7%)	3	0/392 (0%)	0
Acute myocardial infarction	3/401 (0.7%)	6	3/392 (0.8%)	3
Angina pectoris	3/401 (0.7%)	4	4/392 (1%)	4
Arrhythmia	1/401 (0.2%)	1	0/392 (0%)	0
Atrial fibrillation	5/401 (1.2%)	5	6/392 (1.5%)	13
Atrial flutter	1/401 (0.2%)	1	0/392 (0%)	0
Atrial tachycardia	1/401 (0.2%)	1	0/392 (0%)	0
Atrioventricular block complete	0/401 (0%)	0	1/392 (0.3%)	1
Cardiac arrest	3/401 (0.7%)	3	9/392 (2.3%)	9
Cardiac failure	8/401 (2%)	8	10/392 (2.6%)	11
Cardiac failure acute	1/401 (0.2%)	1	1/392 (0.3%)	1
Cardiac failure chronic	1/401 (0.2%)	1	0/392 (0%)	0
Cardiac failure congestive	4/401 (1%)	7	3/392 (0.8%)	3
Cardiac tamponade	0/401 (0%)	0	1/392 (0.3%)	1
Cardio-respiratory arrest	1/401 (0.2%)	1	0/392 (0%)	0
Cardiogenic shock	1/401 (0.2%)	1	0/392 (0%)	0
Cardiopulmonary failure	2/401 (0.5%)	2	1/392 (0.3%)	1
Cardiorenal syndrome	1/401 (0.2%)	1	0/392 (0%)	0
Cardiovascular insufficiency	1/401 (0.2%)	1	0/392 (0%)	0
Coronary artery stenosis	1/401 (0.2%)	1	0/392 (0%)	0
Myocardial infarction	1/401 (0.2%)	1	3/392 (0.8%)	3
Pericardial effusion	0/401 (0%)	0	2/392 (0.5%)	2
Pericarditis	1/401 (0.2%)	1	0/392 (0%)	0
Sinus node dysfunction	1/401 (0.2%)	1	0/392 (0%)	0
Supraventricular tachycardia	1/401 (0.2%)	1	0/392 (0%)	0
Ear and labyrinth disorders
Mastoid disorder	1/401 (0.2%)	1	0/392 (0%)	0
Sudden hearing loss	0/401 (0%)	0	1/392 (0.3%)	1
Vertigo	0/401 (0%)	0	1/392 (0.3%)	1
Endocrine disorders
Diabetes insipidus	1/401 (0.2%)	1	0/392 (0%)	0
Inappropriate antidiuretic hormone secretion	1/401 (0.2%)	1	1/392 (0.3%)	1
Gastrointestinal disorders
Abdominal pain	4/401 (1%)	4	2/392 (0.5%)	2
Abdominal pain upper	0/401 (0%)	0	2/392 (0.5%)	2
Anal fissure	1/401 (0.2%)	2	1/392 (0.3%)	1
Anal fistula	1/401 (0.2%)	1	0/392 (0%)	0
Colitis	3/401 (0.7%)	4	2/392 (0.5%)	2
Colitis ischemic	0/401 (0%)	0	1/392 (0.3%)	1
Constipation	2/401 (0.5%)	2	1/392 (0.3%)	2
Diarrhea	8/401 (2%)	9	7/392 (1.8%)	10
Diverticular perforation	0/401 (0%)	0	1/392 (0.3%)	1
Diverticulum	0/401 (0%)	0	1/392 (0.3%)	1
Dyspepsia	0/401 (0%)	0	1/392 (0.3%)	1
Dysphagia	1/401 (0.2%)	1	0/392 (0%)	0
Enteritis	1/401 (0.2%)	1	0/392 (0%)	0
Fecaloma	0/401 (0%)	0	1/392 (0.3%)	1
Gastric hemorrhage	0/401 (0%)	0	1/392 (0.3%)	1
Gastrointestinal hemorrhage	2/401 (0.5%)	3	1/392 (0.3%)	2
Hemorrhoids	1/401 (0.2%)	1	1/392 (0.3%)	1
Ileus	2/401 (0.5%)	2	0/392 (0%)	0
Ileus paralytic	1/401 (0.2%)	1	0/392 (0%)	0
Incarcerated inguinal hernia	0/401 (0%)	0	1/392 (0.3%)	1
Intestinal perforation	0/401 (0%)	0	2/392 (0.5%)	2
Intussusception	0/401 (0%)	0	1/392 (0.3%)	1
Melaena	3/401 (0.7%)	3	2/392 (0.5%)	2
Mesenteric artery thrombosis	1/401 (0.2%)	1	0/392 (0%)	0
Nausea	0/401 (0%)	0	1/392 (0.3%)	1
Neutropenic colitis	1/401 (0.2%)	1	1/392 (0.3%)	1
Esophagitis	1/401 (0.2%)	1	0/392 (0%)	0
Pancreatitis	2/401 (0.5%)	2	0/392 (0%)	0
Pneumatosis intestinalis	1/401 (0.2%)	1	0/392 (0%)	0
Proctalgia	0/401 (0%)	0	1/392 (0.3%)	1
Rectal hemorrhage	2/401 (0.5%)	2	4/392 (1%)	4
Small intestinal hemorrhage	1/401 (0.2%)	1	0/392 (0%)	0
Small intestinal obstruction	0/401 (0%)	0	1/392 (0.3%)	1
Stomatitis	3/401 (0.7%)	3	1/392 (0.3%)	1
Tooth disorder	0/401 (0%)	0	1/392 (0.3%)	1
Vomiting	2/401 (0.5%)	2	1/392 (0.3%)	2
General disorders
Asthenia	2/401 (0.5%)	2	4/392 (1%)	4
Catheter site erythema	1/401 (0.2%)	1	0/392 (0%)	0
Chest pain	1/401 (0.2%)	1	0/392 (0%)	0
Death	5/401 (1.2%)	5	5/392 (1.3%)	5
Device related thrombosis	1/401 (0.2%)	1	0/392 (0%)	0
Discomfort	0/401 (0%)	0	1/392 (0.3%)	1
Fatigue	1/401 (0.2%)	1	1/392 (0.3%)	1
Gait disturbance	0/401 (0%)	0	2/392 (0.5%)	2
General physical health deterioration	9/401 (2.2%)	9	10/392 (2.6%)	10
Impaired healing	0/401 (0%)	0	1/392 (0.3%)	1
Injection site reaction	1/401 (0.2%)	1	0/392 (0%)	0
Malaise	1/401 (0.2%)	1	0/392 (0%)	0
Multiple organ dysfunction syndrome	5/401 (1.2%)	5	4/392 (1%)	4
Non-cardiac chest pain	2/401 (0.5%)	2	0/392 (0%)	0
Edema peripheral	1/401 (0.2%)	1	0/392 (0%)	0
Pyrexia	16/401 (4%)	19	13/392 (3.3%)	14
Sudden cardiac death	0/401 (0%)	0	1/392 (0.3%)	1
Sudden death	0/401 (0%)	0	2/392 (0.5%)	2
Systemic inflammatory response syndrome	1/401 (0.2%)	1	1/392 (0.3%)	2
Hepatobiliary disorders
Biliary colic	1/401 (0.2%)	1	0/392 (0%)	0
Cholangitis	0/401 (0%)	0	1/392 (0.3%)	1
Cholecystitis acute	1/401 (0.2%)	1	0/392 (0%)	0
Gallbladder obstruction	0/401 (0%)	0	1/392 (0.3%)	1
Hepatitis acute	1/401 (0.2%)	1	0/392 (0%)	0
Ischemic hepatitis	1/401 (0.2%)	1	0/392 (0%)	0
Jaundice cholestatic	1/401 (0.2%)	1	0/392 (0%)	0
Portal vein thrombosis	0/401 (0%)	0	1/392 (0.3%)	1
Immune system disorders
Anaphylactic reaction	1/401 (0.2%)	1	0/392 (0%)	0
Infections and infestations
Abdominal wall abscess	1/401 (0.2%)	2	0/392 (0%)	0
Abscess intestinal	0/401 (0%)	0	1/392 (0.3%)	1
Anal abscess	3/401 (0.7%)	3	1/392 (0.3%)	1
Appendicitis	1/401 (0.2%)	1	0/392 (0%)	0
Arthritis bacterial	0/401 (0%)	0	1/392 (0.3%)	1
Aspergillus infection	3/401 (0.7%)	3	0/392 (0%)	0
Atypical pneumonia	0/401 (0%)	0	2/392 (0.5%)	2
Bacteremia	7/401 (1.7%)	8	2/392 (0.5%)	2
Bacterial infection	2/401 (0.5%)	2	1/392 (0.3%)	1
Bacteroides bacteremia	0/401 (0%)	0	1/392 (0.3%)	1
Bronchitis	6/401 (1.5%)	6	2/392 (0.5%)	2
Bronchopulmonary aspergillosis	2/401 (0.5%)	2	2/392 (0.5%)	2
Campylobacter gastroenteritis	0/401 (0%)	0	1/392 (0.3%)	1
Cellulitis	3/401 (0.7%)	4	6/392 (1.5%)	7
Cellulitis orbital	1/401 (0.2%)	1	0/392 (0%)	0
Cellulitis staphylococcal	1/401 (0.2%)	1	1/392 (0.3%)	1
Clostridium colitis	1/401 (0.2%)	2	0/392 (0%)	0
Clostridium difficile colitis	4/401 (1%)	4	2/392 (0.5%)	3
Clostridium difficile infection	4/401 (1%)	5	2/392 (0.5%)	2
Cystitis	3/401 (0.7%)	3	0/392 (0%)	0
Dermo-hypodermitis	0/401 (0%)	0	1/392 (0.3%)	1
Device related infection	4/401 (1%)	4	7/392 (1.8%)	8
Device related sepsis	2/401 (0.5%)	2	2/392 (0.5%)	2
Diverticulitis	4/401 (1%)	6	1/392 (0.3%)	1
Encephalomyelitis	1/401 (0.2%)	1	0/392 (0%)	0
Endocarditis	0/401 (0%)	0	1/392 (0.3%)	1
Enterobacter infection	1/401 (0.2%)	1	0/392 (0%)	0
Epiglottitis	1/401 (0.2%)	1	0/392 (0%)	0
Erysipelas	2/401 (0.5%)	2	2/392 (0.5%)	2
Escherichia bacteremia	2/401 (0.5%)	2	0/392 (0%)	0
Escherichia infection	1/401 (0.2%)	1	0/392 (0%)	0
Escherichia urinary tract infection	2/401 (0.5%)	2	2/392 (0.5%)	2
Eye infection	1/401 (0.2%)	1	0/392 (0%)	0
Febrile infection	1/401 (0.2%)	1	0/392 (0%)	0
Gastric infection	1/401 (0.2%)	1	0/392 (0%)	0
Gastroenteritis	2/401 (0.5%)	2	2/392 (0.5%)	2
Gastroenteritis pseudomonas	1/401 (0.2%)	1	0/392 (0%)	0
Gastroenteritis viral	1/401 (0.2%)	1	0/392 (0%)	0
Gingivitis	1/401 (0.2%)	1	0/392 (0%)	0
H1N1 influenza	0/401 (0%)	0	1/392 (0.3%)	1
Hematoma infection	2/401 (0.5%)	2	0/392 (0%)	0
Hepatosplenic abscess	1/401 (0.2%)	1	0/392 (0%)	0
Herpes simplex	1/401 (0.2%)	1	0/392 (0%)	0
Herpes zoster	1/401 (0.2%)	1	1/392 (0.3%)	1
Herpes zoster oticus	1/401 (0.2%)	1	0/392 (0%)	0
Infection	6/401 (1.5%)	6	5/392 (1.3%)	6
Infectious colitis	0/401 (0%)	0	1/392 (0.3%)	1
Influenza	6/401 (1.5%)	6	3/392 (0.8%)	3
Injection site abscess	1/401 (0.2%)	1	0/392 (0%)	0
Injection site cellulitis	1/401 (0.2%)	1	0/392 (0%)	0
Injection site infection	1/401 (0.2%)	1	0/392 (0%)	0
Kidney infection	1/401 (0.2%)	1	0/392 (0%)	0
Klebsiella infection	3/401 (0.7%)	3	0/392 (0%)	0
Liver abscess	1/401 (0.2%)	1	0/392 (0%)	0
Localized infection	2/401 (0.5%)	2	1/392 (0.3%)	1
Lower respiratory tract infection	0/401 (0%)	0	1/392 (0.3%)	1
Mastoiditis	1/401 (0.2%)	1	0/392 (0%)	0
Mucormycosis	1/401 (0.2%)	1	1/392 (0.3%)	1
Muscle abscess	1/401 (0.2%)	1	1/392 (0.3%)	1
Neutropenic infection	0/401 (0%)	0	1/392 (0.3%)	1
Osteomyelitis	1/401 (0.2%)	1	1/392 (0.3%)	1
Otitis media	0/401 (0%)	0	1/392 (0.3%)	1
Otitis media acute	1/401 (0.2%)	1	1/392 (0.3%)	1
Parotitis	2/401 (0.5%)	3	0/392 (0%)	0
Pathogen resistance	1/401 (0.2%)	1	0/392 (0%)	0
Periorbital cellulitis	1/401 (0.2%)	1	0/392 (0%)	0
Peritonitis	0/401 (0%)	0	1/392 (0.3%)	1
Periumbilical abscess	1/401 (0.2%)	1	0/392 (0%)	0
Pharyngitis	2/401 (0.5%)	2	1/392 (0.3%)	2
Pneumocystis jirovecii pneumonia	0/401 (0%)	0	1/392 (0.3%)	1
Pneumonia	117/401 (29.2%)	147	79/392 (20.2%)	102
Pneumonia cytomegaloviral	0/401 (0%)	0	1/392 (0.3%)	1
Pneumonia influenzal	0/401 (0%)	0	1/392 (0.3%)	1
Pneumonia legionella	1/401 (0.2%)	1	0/392 (0%)	0
Pneumonia pseudomonal	1/401 (0.2%)	1	0/392 (0%)	0
Post procedural cellulitis	0/401 (0%)	0	1/392 (0.3%)	1
Postoperative wound infection	0/401 (0%)	0	1/392 (0.3%)	1
Pseudomembranous colitis	0/401 (0%)	0	1/392 (0.3%)	1
Pseudomonal sepsis	1/401 (0.2%)	1	0/392 (0%)	0
Pseudomonas infection	2/401 (0.5%)	2	0/392 (0%)	0
Pulmonary tuberculosis	1/401 (0.2%)	1	0/392 (0%)	0
Pulpitis dental	0/401 (0%)	0	1/392 (0.3%)	1
Pyelonephritis	2/401 (0.5%)	2	2/392 (0.5%)	2
Pyelonephritis acute	1/401 (0.2%)	1	0/392 (0%)	0
Rectal abscess	0/401 (0%)	0	1/392 (0.3%)	1
Respiratory syncytial virus infection	1/401 (0.2%)	1	0/392 (0%)	0
Respiratory tract infection	1/401 (0.2%)	1	0/392 (0%)	0
Scrotal infection	1/401 (0.2%)	1	0/392 (0%)	0
Sepsis	62/401 (15.5%)	83	44/392 (11.2%)	58
Septic shock	16/401 (4%)	17	17/392 (4.3%)	19
Septic vasculitis	1/401 (0.2%)	1	0/392 (0%)	0
Sinusitis	0/401 (0%)	0	4/392 (1%)	4
Sinusitis fungal	1/401 (0.2%)	1	0/392 (0%)	0
Skin infection	1/401 (0.2%)	1	0/392 (0%)	0
Soft tissue infection	3/401 (0.7%)	3	2/392 (0.5%)	2
Staphylococcal bacteremia	1/401 (0.2%)	1	0/392 (0%)	0
Staphylococcal infection	1/401 (0.2%)	1	1/392 (0.3%)	1
Staphylococcal sepsis	2/401 (0.5%)	2	3/392 (0.8%)	3
Streptococcal bacteremia	0/401 (0%)	0	1/392 (0.3%)	1
Systemic candida	0/401 (0%)	0	1/392 (0.3%)	1
Systemic infection	0/401 (0%)	0	1/392 (0.3%)	1
Tonsillitis	1/401 (0.2%)	1	1/392 (0.3%)	1
Tooth infection	2/401 (0.5%)	3	1/392 (0.3%)	1
Tuberculous pleurisy	1/401 (0.2%)	1	0/392 (0%)	0
Upper respiratory tract infection	4/401 (1%)	4	1/392 (0.3%)	1
Urethritis	1/401 (0.2%)	1	0/392 (0%)	0
Urinary tract infection	14/401 (3.5%)	16	10/392 (2.6%)	11
Urinary tract infection enterococcal	3/401 (0.7%)	3	0/392 (0%)	0
Urosepsis	3/401 (0.7%)	3	0/392 (0%)	0
Viral infection	1/401 (0.2%)	1	0/392 (0%)	0
Wound infection	1/401 (0.2%)	1	0/392 (0%)	0
Wound infection staphylococcal	2/401 (0.5%)	2	0/392 (0%)	0
Bronchopulmonary aspergillosis allergic	0/401 (0%)	0	1/392 (0.3%)	1
Urinary tract infection staphylococcal	1/401 (0.2%)	1	1/392 (0.3%)	1
Injury, poisoning and procedural complications
Allergic transfusion reaction	1/401 (0.2%)	2	1/392 (0.3%)	1
Ankle fracture	1/401 (0.2%)	1	0/392 (0%)	0
Concussion	0/401 (0%)	0	1/392 (0.3%)	1
Contusion	0/401 (0%)	0	1/392 (0.3%)	1
Craniocerebral injury	0/401 (0%)	0	1/392 (0.3%)	1
Fall	1/401 (0.2%)	1	2/392 (0.5%)	2
Femur fracture	2/401 (0.5%)	2	1/392 (0.3%)	1
Fibula fracture	0/401 (0%)	0	1/392 (0.3%)	1
Fracture	1/401 (0.2%)	1	0/392 (0%)	0
Hemolytic transfusion reaction	1/401 (0.2%)	1	0/392 (0%)	0
Head injury	1/401 (0.2%)	1	0/392 (0%)	0
Hip fracture	1/401 (0.2%)	1	0/392 (0%)	0
Humerus fracture	1/401 (0.2%)	1	0/392 (0%)	0
Infusion related reaction	1/401 (0.2%)	1	1/392 (0.3%)	1
Joint dislocation	0/401 (0%)	0	1/392 (0.3%)	1
Pelvic fracture	0/401 (0%)	0	1/392 (0.3%)	1
Rib fracture	0/401 (0%)	0	1/392 (0.3%)	1
Spinal compression fracture	1/401 (0.2%)	1	2/392 (0.5%)	2
Splenic rupture	0/401 (0%)	0	1/392 (0.3%)	1
Subarachnoid hemorrhage	1/401 (0.2%)	1	1/392 (0.3%)	1
Subdural hematoma	2/401 (0.5%)	2	1/392 (0.3%)	1
Subdural hemorrhage	1/401 (0.2%)	1	0/392 (0%)	0
Tibia fracture	0/401 (0%)	0	1/392 (0.3%)	1
Transfusion reaction	4/401 (1%)	4	0/392 (0%)	0
Traumatic lung injury	0/401 (0%)	0	1/392 (0.3%)	2
Upper limb fracture	0/401 (0%)	0	1/392 (0.3%)	1
Investigations
Blood bilirubin increased	1/401 (0.2%)	1	0/392 (0%)	0
C-reactive protein increased	3/401 (0.7%)	3	3/392 (0.8%)	3
Influenza A virus test positive	0/401 (0%)	0	1/392 (0.3%)	1
Metabolism and nutrition disorders
Decreased appetite	2/401 (0.5%)	2	0/392 (0%)	0
Dehydration	2/401 (0.5%)	2	4/392 (1%)	4
Failure to thrive	0/401 (0%)	0	1/392 (0.3%)	1
Hypercalcemia	1/401 (0.2%)	2	0/392 (0%)	0
Hyperglycemia	1/401 (0.2%)	1	2/392 (0.5%)	2
Hypoglycemia	1/401 (0.2%)	1	0/392 (0%)	0
Hypokalemia	2/401 (0.5%)	2	4/392 (1%)	5
Hyponatremia	1/401 (0.2%)	1	3/392 (0.8%)	4
Tumor lysis syndrome	5/401 (1.2%)	5	2/392 (0.5%)	2
Musculoskeletal and connective tissue disorders
Arthritis	1/401 (0.2%)	1	0/392 (0%)	0
Back pain	0/401 (0%)	0	2/392 (0.5%)	2
Bone pain	2/401 (0.5%)	2	0/392 (0%)	0
Bursitis	1/401 (0.2%)	1	0/392 (0%)	0
Intervertebral disc protrusion	0/401 (0%)	0	1/392 (0.3%)	1
Joint effusion	0/401 (0%)	0	1/392 (0.3%)	1
Lumbar spinal stenosis	0/401 (0%)	0	1/392 (0.3%)	1
Muscle atrophy	1/401 (0.2%)	1	0/392 (0%)	0
Muscle hemorrhage	1/401 (0.2%)	1	0/392 (0%)	0
Musculoskeletal pain	0/401 (0%)	0	2/392 (0.5%)	2
Neck pain	0/401 (0%)	0	1/392 (0.3%)	1
Osteoarthritis	2/401 (0.5%)	2	2/392 (0.5%)	3
Osteonecrosis	1/401 (0.2%)	1	0/392 (0%)	0
Pain in extremity	1/401 (0.2%)	1	2/392 (0.5%)	2
Rhabdomyolysis	1/401 (0.2%)	1	0/392 (0%)	0
Shoulder deformity	0/401 (0%)	0	1/392 (0.3%)	1
Spinal pain	0/401 (0%)	0	2/392 (0.5%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma	0/401 (0%)	0	1/392 (0.3%)	1
Basal cell carcinoma	2/401 (0.5%)	2	0/392 (0%)	0
Bile duct cancer	1/401 (0.2%)	1	0/392 (0%)	0
Biliary neoplasm	1/401 (0.2%)	1	0/392 (0%)	0
Central nervous system leukemia	0/401 (0%)	0	1/392 (0.3%)	1
Chloroma	1/401 (0.2%)	1	0/392 (0%)	0
Endometrial cancer metastatic	1/401 (0.2%)	1	0/392 (0%)	0
Kaposi's sarcoma	1/401 (0.2%)	1	0/392 (0%)	0
Lung adenocarcinoma	1/401 (0.2%)	1	0/392 (0%)	0
Metastatic squamous cell carcinoma	1/401 (0.2%)	1	0/392 (0%)	0
Squamous cell carcinoma	1/401 (0.2%)	1	0/392 (0%)	0
Transitional cell carcinoma	1/401 (0.2%)	1	0/392 (0%)	0
Tumor associated fever	0/401 (0%)	0	1/392 (0.3%)	1
Nervous system disorders
Cerebral hemorrhage	1/401 (0.2%)	1	2/392 (0.5%)	2
Cerebrovascular accident	6/401 (1.5%)	6	2/392 (0.5%)	2
Depressed level of consciousness	0/401 (0%)	0	1/392 (0.3%)	1
Epilepsy	0/401 (0%)	0	1/392 (0.3%)	1
Facial paralysis	1/401 (0.2%)	1	0/392 (0%)	0
Hemorrhage intracranial	1/401 (0.2%)	1	4/392 (1%)	5
Hemorrhagic stroke	1/401 (0.2%)	1	1/392 (0.3%)	1
Headache	1/401 (0.2%)	1	1/392 (0.3%)	1
Intracranial hematoma	0/401 (0%)	0	1/392 (0.3%)	1
Ischemic stroke	2/401 (0.5%)	2	1/392 (0.3%)	1
Lethargy	0/401 (0%)	0	1/392 (0.3%)	1
Nervous system disorder	1/401 (0.2%)	1	0/392 (0%)	0
Peroneal nerve palsy	0/401 (0%)	0	1/392 (0.3%)	1
Presyncope	0/401 (0%)	0	1/392 (0.3%)	2
Seizure	2/401 (0.5%)	2	2/392 (0.5%)	2
Syncope	2/401 (0.5%)	2	4/392 (1%)	6
Transient ischemic attack	1/401 (0.2%)	1	2/392 (0.5%)	2
Vocal cord paralysis	0/401 (0%)	0	1/392 (0.3%)	1
Product Issues
Device dislocation	0/401 (0%)	0	1/392 (0.3%)	1
Psychiatric disorders
Confusional state	4/401 (1%)	4	0/392 (0%)	0
Delirium	1/401 (0.2%)	1	1/392 (0.3%)	1
Depression	0/401 (0%)	0	1/392 (0.3%)	1
Personality change	0/401 (0%)	0	1/392 (0.3%)	1
Suicide attempt	1/401 (0.2%)	1	0/392 (0%)	0
Renal and urinary disorders
Acute kidney injury	11/401 (2.7%)	11	15/392 (3.8%)	16
Chronic kidney disease	0/401 (0%)	0	1/392 (0.3%)	1
Cystitis hemorrhagic	1/401 (0.2%)	2	0/392 (0%)	0
Hematuria	2/401 (0.5%)	2	2/392 (0.5%)	2
Renal colic	0/401 (0%)	0	1/392 (0.3%)	1
Renal failure	4/401 (1%)	4	2/392 (0.5%)	2
Ureterolithiasis	0/401 (0%)	0	1/392 (0.3%)	1
Urinary retention	1/401 (0.2%)	1	0/392 (0%)	0
Urinary tract obstruction	1/401 (0.2%)	1	0/392 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema	2/401 (0.5%)	2	1/392 (0.3%)	1
Acute respiratory distress syndrome	2/401 (0.5%)	2	0/392 (0%)	0
Acute respiratory failure	2/401 (0.5%)	2	6/392 (1.5%)	6
Aspiration	1/401 (0.2%)	1	2/392 (0.5%)	2
Asthma	0/401 (0%)	0	1/392 (0.3%)	1
Chronic obstructive pulmonary disease	2/401 (0.5%)	3	1/392 (0.3%)	1
Dyspnea	2/401 (0.5%)	2	2/392 (0.5%)	2
Epistaxis	3/401 (0.7%)	3	3/392 (0.8%)	3
Hemoptysis	0/401 (0%)	0	1/392 (0.3%)	1
Interstitial lung disease	1/401 (0.2%)	1	1/392 (0.3%)	1
Laryngeal inflammation	1/401 (0.2%)	1	0/392 (0%)	0
Laryngeal edema	0/401 (0%)	0	1/392 (0.3%)	1
Organizing pneumonia	2/401 (0.5%)	2	1/392 (0.3%)	1
Oropharyngeal pain	1/401 (0.2%)	1	0/392 (0%)	0
Pleural effusion	6/401 (1.5%)	7	3/392 (0.8%)	3
Pleuritic pain	1/401 (0.2%)	1	1/392 (0.3%)	1
Pneumonia aspiration	1/401 (0.2%)	1	1/392 (0.3%)	1
Pneumonitis	3/401 (0.7%)	3	0/392 (0%)	0
Pulmonary alveolar hemorrhage	0/401 (0%)	0	1/392 (0.3%)	1
Pulmonary embolism	2/401 (0.5%)	2	0/392 (0%)	0
Pulmonary hemorrhage	0/401 (0%)	0	1/392 (0.3%)	1
Pulmonary mass	1/401 (0.2%)	1	0/392 (0%)	0
Pulmonary edema	5/401 (1.2%)	5	1/392 (0.3%)	1
Respiratory distress	2/401 (0.5%)	2	1/392 (0.3%)	1
Respiratory failure	5/401 (1.2%)	5	2/392 (0.5%)	2
Stridor	1/401 (0.2%)	1	0/392 (0%)	0
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis	1/401 (0.2%)	1	0/392 (0%)	0
Angioedema	2/401 (0.5%)	2	0/392 (0%)	0
Dermatitis	0/401 (0%)	0	1/392 (0.3%)	1
Eczema	1/401 (0.2%)	1	0/392 (0%)	0
Hypersensitivity vasculitis	1/401 (0.2%)	1	0/392 (0%)	0
Pyoderma gangrenosum	1/401 (0.2%)	3	0/392 (0%)	0
Rash generalized	0/401 (0%)	0	1/392 (0.3%)	1
Rash maculo-papular	0/401 (0%)	0	1/392 (0.3%)	1
Skin disorder	0/401 (0%)	0	1/392 (0.3%)	1
Skin ulcer	0/401 (0%)	0	1/392 (0.3%)	1
Toxic skin eruption	1/401 (0.2%)	1	0/392 (0%)	0
Vascular disorders
Aortic aneurysm	0/401 (0%)	0	1/392 (0.3%)	1
Aortic dissection	1/401 (0.2%)	1	0/392 (0%)	0
Artery dissection	1/401 (0.2%)	1	0/392 (0%)	0
Circulatory collapse	5/401 (1.2%)	5	4/392 (1%)	4
Deep vein thrombosis	2/401 (0.5%)	2	0/392 (0%)	0
Hematoma	3/401 (0.7%)	3	1/392 (0.3%)	2
Hypertension	0/401 (0%)	0	2/392 (0.5%)	2
Hypotension	2/401 (0.5%)	2	3/392 (0.8%)	3
Iliac artery embolism	0/401 (0%)	0	1/392 (0.3%)	1
Leriche syndrome	1/401 (0.2%)	1	0/392 (0%)	0
Lupus vasculitis	0/401 (0%)	0	1/392 (0.3%)	1
Orthostatic hypotension	0/401 (0%)	0	1/392 (0.3%)	1
Peripheral arterial occlusive disease	1/401 (0.2%)	1	0/392 (0%)	0
Phlebitis	1/401 (0.2%)	1	0/392 (0%)	0
Shock	1/401 (0.2%)	1	0/392 (0%)	0
Shock hemorrhagic	0/401 (0%)	0	1/392 (0.3%)	1
Thrombophlebitis	2/401 (0.5%)	2	0/392 (0%)	0
Venous thrombosis	0/401 (0%)	0	1/392 (0.3%)	1
Other (Not Including Serious) Adverse Events
	SGI-110 (Guadecitabine)		Treatment Choice
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	379/401 (94.5%)		371/392 (94.6%)
Blood and lymphatic system disorders
Anemia	88/401 (21.9%)	211	78/392 (19.9%)	201
Febrile neutropenia	66/401 (16.5%)	103	40/392 (10.2%)	57
Leukopenia	37/401 (9.2%)	120	33/392 (8.4%)	124
Neutropenia	115/401 (28.7%)	319	88/392 (22.4%)	233
Thrombocytopenia	116/401 (28.9%)	380	101/392 (25.8%)	313
Gastrointestinal disorders
Abdominal pain	30/401 (7.5%)	43	46/392 (11.7%)	50
Abdominal pain upper	21/401 (5.2%)	25	15/392 (3.8%)	16
Constipation	125/401 (31.2%)	166	114/392 (29.1%)	168
Diarrhea	122/401 (30.4%)	169	83/392 (21.2%)	116
Hemorrhoids	24/401 (6%)	28	19/392 (4.8%)	24
Nausea	91/401 (22.7%)	141	108/392 (27.6%)	150
Stomatitis	46/401 (11.5%)	59	38/392 (9.7%)	44
Vomiting	58/401 (14.5%)	80	66/392 (16.8%)	82
General disorders
Asthenia	61/401 (15.2%)	102	55/392 (14%)	81
Fatigue	63/401 (15.7%)	97	50/392 (12.8%)	74
Injection site reaction	73/401 (18.2%)	148	48/392 (12.2%)	75
Edema peripheral	95/401 (23.7%)	125	78/392 (19.9%)	108
Pain	21/401 (5.2%)	22	14/392 (3.6%)	14
Pyrexia	89/401 (22.2%)	155	110/392 (28.1%)	176
Infections and infestations
Bronchitis	22/401 (5.5%)	30	13/392 (3.3%)	15
Cellulitis	29/401 (7.2%)	37	22/392 (5.6%)	25
Nasopharyngitis	18/401 (4.5%)	27	20/392 (5.1%)	21
Oral candidiasis	23/401 (5.7%)	27	17/392 (4.3%)	21
Oral herpes	31/401 (7.7%)	36	20/392 (5.1%)	21
Pneumonia	54/401 (13.5%)	64	31/392 (7.9%)	34
Upper respiratory tract infection	22/401 (5.5%)	34	20/392 (5.1%)	28
Urinary tract infection	33/401 (8.2%)	46	28/392 (7.1%)	39
Injury, poisoning and procedural complications
Contusion	20/401 (5%)	23	22/392 (5.6%)	27
Fall	34/401 (8.5%)	43	29/392 (7.4%)	37
Investigations
Weight decreased	35/401 (8.7%)	47	25/392 (6.4%)	28
Metabolism and nutrition disorders
Decreased appetite	89/401 (22.2%)	116	62/392 (15.8%)	80
Hyperkalemia	24/401 (6%)	33	13/392 (3.3%)	19
Hypoalbuminemia	26/401 (6.5%)	36	23/392 (5.9%)	43
Hypocalcemia	25/401 (6.2%)	30	18/392 (4.6%)	29
Hypokalemia	96/401 (23.9%)	173	77/392 (19.6%)	128
Hypomagnesemia	31/401 (7.7%)	50	27/392 (6.9%)	36
Musculoskeletal and connective tissue disorders
Arthralgia	24/401 (6%)	28	35/392 (8.9%)	39
Back pain	34/401 (8.5%)	43	36/392 (9.2%)	43
Musculoskeletal pain	17/401 (4.2%)	20	20/392 (5.1%)	22
Pain in extremity	40/401 (10%)	51	32/392 (8.2%)	39
Nervous system disorders
Dizziness	36/401 (9%)	47	42/392 (10.7%)	56
Headache	32/401 (8%)	44	38/392 (9.7%)	53
Psychiatric disorders
Anxiety	23/401 (5.7%)	23	22/392 (5.6%)	24
Depression	14/401 (3.5%)	15	21/392 (5.4%)	21
Insomnia	38/401 (9.5%)	52	45/392 (11.5%)	56
Renal and urinary disorders
Acute kidney injury	23/401 (5.7%)	24	16/392 (4.1%)	17
Respiratory, thoracic and mediastinal disorders
Cough	79/401 (19.7%)	100	66/392 (16.8%)	83
Dyspnea	63/401 (15.7%)	83	51/392 (13%)	60
Epistaxis	53/401 (13.2%)	71	36/392 (9.2%)	51
Oropharyngeal pain	22/401 (5.5%)	29	23/392 (5.9%)	27
Pleural effusion	21/401 (5.2%)	23	13/392 (3.3%)	13
Skin and subcutaneous tissue disorders
Erythema	21/401 (5.2%)	21	17/392 (4.3%)	20
Pruritis	22/401 (5.5%)	28	26/392 (6.6%)	32
Rash	41/401 (10.2%)	55	28/392 (7.1%)	33
Vascular disorders
Hematoma	25/401 (6.2%)	33	19/392 (4.8%)	29
Hypertension	28/401 (7%)	42	25/392 (6.4%)	37
Hypotension	31/401 (7.7%)	40	31/392 (7.9%)	37

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Dr. Harold Keer
Organization	Astex Pharmaceuticals, Inc.
Phone	925-560-2913
Email	harold.keer@astx.com

Responsible Party:

Astex Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT02348489

Other Study ID Numbers:

SGI-110-04

First Posted:

Jan 28, 2015

Last Update Posted:

Jan 14, 2021

Last Verified:

Dec 1, 2020

SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

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Certain Agreements

Results Point of Contact