NCT02907359 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- From first dose through end of study (up to approximately 46.6 months)
- Other-event reporting threshold
- 5%
All-cause mortality:The Efficacy Analysis Set included all participants randomly assigned to study treatment. Serious and other adverse events:The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen. As pre-specified in the protocol, participants were grouped, and data was collected according to treatment received (Guadecitabine/Treatment Choice)for adverse events.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Guadecitabine | 216 / 270 | 266 / 270 | 237 / 277 |
| Treatment Choice | 65 / 122 | 107 / 122 | 122 / 140 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 80
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 122
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 122
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 122
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 122
- term
- Febrile Bone Marrow Aplasia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 122
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Leukocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Leukostasis Syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Lymphadenitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Lymphadenopathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Splenic Infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Thrombocytopenic Purpura
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 63
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 122
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 122
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 122
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 92
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 122
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 84
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 25
- num At Risk
- 122
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 122
- term
- Abdominal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 62
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 122
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 122
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 122
- term
- Haemorrhoids
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 122
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 122
- term
- Stomatitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 122
- term
- Vomiting
Complete source fields
- description
- All-cause mortality:The Efficacy Analysis Set included all participants randomly assigned to study treatment. Serious and other adverse events:The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen. As pre-specified in the protocol, participants were grouped, and data was collected according to treatment received (Guadecitabine/Treatment Choice)for adverse events.
- event Groups
- deaths Num Affected
- 237
- deaths Num At Risk
- 277
- description
- Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
- id
- EG000
- other Num Affected
- 266
- other Num At Risk
- 270
- serious Num Affected
- 216
- serious Num At Risk
- 270
- title
- Guadecitabine
- deaths Num Affected
- 122
- deaths Num At Risk
- 140
- description
- Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
- id
- EG001
- other Num Affected
- 107
- other Num At Risk
- 122
- serious Num Affected
- 65
- serious Num At Risk
- 122
- title
- Treatment Choice
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 63
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 122
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 122
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 122
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 92
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 122
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 84
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 25
- num At Risk
- 122
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 122
- term
- Abdominal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 62
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 122
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 60
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 20
- num At Risk
- 122
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 122
- term
- Haemorrhoids
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 122
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 38
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 122
- term
- Stomatitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 122
- term
- Vomiting
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 80
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 122
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 122
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 122
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 122
- term
- Febrile Bone Marrow Aplasia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 122
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Leukocytosis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Leukostasis Syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Lymphadenitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Lymphadenopathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Splenic Infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 21.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 270
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 122
- term
- Thrombocytopenic Purpura
- time Frame
- From first dose through end of study (up to approximately 46.6 months)
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