NCT02281084 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes · Source last updated 2024-10-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From first dose until 28 days after the last dose of CC-486 (90 days after the last dose of durvalumab) or the last follow up visit, whichever date is later (Up to 91 months)

What was measured

TEAEs were defined as AEs occurring or worsening on or after the date of the first dose of oral aza or durva and within 28 days after last dose of oral aza or 90 days after last dose of durva A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.

Analysis population: The safety population included all enrolled participants who received at least 1 dose of IP and had at least 1 post-dose safety assessment.

Groups in this outcome

Stable Disease (SD) Cohort: Oral Azacitidine

Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Progressive Disease (PD) Cohort: Oral Azacitidine

Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Stable Disease Cohort: Oral Azacitidine and Durvalumab

Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Progressive Disease Cohort: Oral Azacitidine and Durvalumab

Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Stable Disease (SD) Cohort: Oral Azacitidine	32
Progressive Disease (PD) Cohort: Oral Azacitidine	22
Stable Disease Cohort: Oral Azacitidine and Durvalumab	6
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	5

Reported measurements

≥ 1 TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	32	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	22	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	6	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	5	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Related to (R/T) Oral Azacitidine (AZA)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	28	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	20	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	6	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE R/T Durvalumab (Durva)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	5	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE R/T Oral AZA or Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	28	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	20	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	6	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported

≥ 1 Serious TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	25	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	15	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	5	Not reported	Not reported	Not reported	Not reported

≥ 1 Serious TEAE R/T Oral AZA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	4	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	3	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	2	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	1	Not reported	Not reported	Not reported	Not reported

≥ 1 Serious TEAE R/T Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	1	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	1	Not reported	Not reported	Not reported	Not reported

≥ 1 Serious TEAE R/T Oral AZA or Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	4	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	3	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	2	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	1	Not reported	Not reported	Not reported	Not reported

≥ 1 NCI CTC Grade (GR) 3 or 4 TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	32	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	19	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	5	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	5	Not reported	Not reported	Not reported	Not reported

≥ 1 NCI CTC GR 3 or 4 TEAE R/T Oral AZA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	18	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	10	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	3	Not reported	Not reported	Not reported	Not reported

≥ 1 NCI CTC GR 3 or 4 TEAE R/T Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	2	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	2	Not reported	Not reported	Not reported	Not reported

≥ 1 NCI CTC GR 3 or 4 TEAE R/T AZA or Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	18	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	10	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	3	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to Death

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	4	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	4	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	2	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	0	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to Death R/T Oral AZA

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to Death R/T Durva

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to Death R/T AZA or Durva

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to Dose Reduction of AZA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	10	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	8	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	1	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	0	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to Reduction of Durva

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to Reduction of AZA or Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	10	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	8	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	1	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	0	Not reported	Not reported	Not reported	Not reported

≥1 TEAE Leading to Interruption of AZA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	21	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	13	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	3	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported

≥1 TEAE Leading to Interruption of Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	2	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	0	Not reported	Not reported	Not reported	Not reported

≥1 TEAE Leading to Interruption of AZA or Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	21	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	13	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	3	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to Discontinuation (D/C) of AZA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	15	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	8	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to D/C of Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	0	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	3	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	3	Not reported	Not reported	Not reported	Not reported

≥ 1 TEAE Leading to D/C of AZA or Durva

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Stable Disease (SD) Cohort: Oral Azacitidine	15	Not reported	Not reported	Not reported	Not reported
Progressive Disease (PD) Cohort: Oral Azacitidine	8	Not reported	Not reported	Not reported	Not reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
32
group Id
OG001
value
22
group Id
OG002
value
6
group Id
OG003
value
5
title
≥ 1 TEAE
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
20
group Id
OG002
value
6
group Id
OG003
value
4
title
≥ 1 TEAE Related to (R/T) Oral Azacitidine (AZA)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
5
group Id
OG003
value
4
title
≥ 1 TEAE R/T Durvalumab (Durva)
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
20
group Id
OG002
value
6
group Id
OG003
value
4
title
≥ 1 TEAE R/T Oral AZA or Durva
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
15
group Id
OG002
value
4
group Id
OG003
value
5
title
≥ 1 Serious TEAE
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
1
title
≥ 1 Serious TEAE R/T Oral AZA
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
title
≥ 1 Serious TEAE R/T Durva
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
1
title
≥ 1 Serious TEAE R/T Oral AZA or Durva
categories
measurements
group Id
OG000
value
32
group Id
OG001
value
19
group Id
OG002
value
5
group Id
OG003
value
5
title
≥ 1 NCI CTC Grade (GR) 3 or 4 TEAE
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
10
group Id
OG002
value
4
group Id
OG003
value
3
title
≥ 1 NCI CTC GR 3 or 4 TEAE R/T Oral AZA
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
2
title
≥ 1 NCI CTC GR 3 or 4 TEAE R/T Durva
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
10
group Id
OG002
value
4
group Id
OG003
value
3
title
≥ 1 NCI CTC GR 3 or 4 TEAE R/T AZA or Durva

denoms

counts
group Id
OG000
value
32
group Id
OG001
value
22
group Id
OG002
value
6
group Id
OG003
value
5
units
Participants

description

groups

description
Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
id
OG000
title
Stable Disease (SD) Cohort: Oral Azacitidine
description
Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
id
OG001
title
Progressive Disease (PD) Cohort: Oral Azacitidine
description
Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
id
OG002
title
Stable Disease Cohort: Oral Azacitidine and Durvalumab
description
Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
id
OG003
title
Progressive Disease Cohort: Oral Azacitidine and Durvalumab

param Type

COUNT_OF_PARTICIPANTS

population Description

The safety population included all enrolled participants who received at least 1 dose of IP and had at least 1 post-dose safety assessment.

reporting Status

POSTED

time Frame

From first dose until 28 days after the last dose of CC-486 (90 days after the last dose of durvalumab) or the last follow up visit, whichever date is later (Up to 91 months)

title

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice