NCT00629343 · ADVERSE EVENTS

Adverse events

Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide · Source last updated 2025-06-05

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: up to 59 months after enrollment
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Azacitidine 25 mg Cohort 1: Participants received 25 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.	0 / 3	0 / 3	0 / 3
Azacitidine 50 mg Cohort 2: Participants received 50 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.	0 / 3	0 / 3	0 / 3
Azacitidine 75 mg Cohort 3: Participants received 75 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.	15 / 17	0 / 17	15 / 17

Group identifiers: EG000: Azacitidine 25 mg · EG001: Azacitidine 50 mg · EG002: Azacitidine 75 mg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
15
num At Risk
17
term
Death due to progression of disease

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Cohort 1: Participants received 25 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
id
EG000
other Num Affected
0
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Azacitidine 25 mg
deaths Num Affected
0
deaths Num At Risk
3
description
Cohort 2: Participants received 50 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
id
EG001
other Num Affected
0
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Azacitidine 50 mg
deaths Num Affected
15
deaths Num At Risk
17
description
Cohort 3: Participants received 75 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
id
EG002
other Num Affected
0
other Num At Risk
17
serious Num Affected
15
serious Num At Risk
17
title
Azacitidine 75 mg

frequency Threshold

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
15
num At Risk
17
term
Death due to progression of disease

time Frame

up to 59 months after enrollment

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice