NCT04537715 · ADVERSE EVENTS

Adverse events

Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels · Source last updated 2025-02-19

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: Treatment-emergent adverse events and all-cause mortality were reported from the first dose of study treatment (Day 1) through 30 days after the end of study treatment (approximately 33 months).
Other-event reporting threshold: 5%

The Safety population included all participants in the Enrolled population who received at least 1 dose or partial dose of the study treatments and had 1 post-dose safety observation recorded.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1: Tazemetostat + Itraconazole Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. A single oral dose of 200 mg itraconazole was administered daily from Day 18 to Day 20. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Itraconazole was also administered on Days 37 and 38 as a single oral 200 mg daily dose. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).	8 / 21	19 / 21	10 / 21
Part 2: Tazemetostat + Rifampin Participants received a single oral dose of 800 mg tazemetostat on Cycle 1 Day 1, BID dose of 800 mg of tazemetostat from Days 3 to 14 and a single oral dose of 800 mg tazemetostat on Day 15. From Days 17 to 23, they received an 800 mg BID dose of tazemetostat co-administered with a single dose of oral 600 mg rifampin. On Day 24, subjects received a single dose of 800 mg tazemetostat co-administered with a single dose of oral 600 mg rifampin. Rifampin was also administered on Cycle 1 Day 25 as a single oral 600 mg dose. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 27 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).	9 / 21	20 / 21	3 / 21

Group identifiers: EG000: Part 1: Tazemetostat + Itraconazole · EG001: Part 2: Tazemetostat + Rifampin

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
2
num At Risk
21
num Events
2
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Enterocolitis infectious
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Urinary tract infection

Other reported adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
6
num At Risk
21
num Events
10
group Id
EG001
num Affected
5
num At Risk
21
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
6
num At Risk
21
num Events
9
group Id
EG001
num Affected
5
num At Risk
21
num Events
6
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
5
num At Risk
21
num Events
5
group Id
EG001
num Affected
5
num At Risk
21
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
7
num At Risk
21
num Events
9
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
4
num At Risk
21
num Events
4
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
3
num At Risk
21
num Events
4
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
2
num At Risk
21
num Events
2
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
6
num At Risk
21
num Events
6
group Id
EG001
num Affected
9
num At Risk
21
num Events
10
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
3
num At Risk
21
num Events
3
term
Non-cardiac chest pain

Complete source fields

description

The Safety population included all participants in the Enrolled population who received at least 1 dose or partial dose of the study treatments and had 1 post-dose safety observation recorded.

event Groups

deaths Num Affected
10
deaths Num At Risk
21
description
Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. A single oral dose of 200 mg itraconazole was administered daily from Day 18 to Day 20. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Itraconazole was also administered on Days 37 and 38 as a single oral 200 mg daily dose. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
id
EG000
other Num Affected
19
other Num At Risk
21
serious Num Affected
8
serious Num At Risk
21
title
Part 1: Tazemetostat + Itraconazole
deaths Num Affected
3
deaths Num At Risk
21
description
Participants received a single oral dose of 800 mg tazemetostat on Cycle 1 Day 1, BID dose of 800 mg of tazemetostat from Days 3 to 14 and a single oral dose of 800 mg tazemetostat on Day 15. From Days 17 to 23, they received an 800 mg BID dose of tazemetostat co-administered with a single dose of oral 600 mg rifampin. On Day 24, subjects received a single dose of 800 mg tazemetostat co-administered with a single dose of oral 600 mg rifampin. Rifampin was also administered on Cycle 1 Day 25 as a single oral 600 mg dose. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 27 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).
id
EG001
other Num Affected
20
other Num At Risk
21
serious Num Affected
9
serious Num At Risk
21
title
Part 2: Tazemetostat + Rifampin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
6
num At Risk
21
num Events
10
group Id
EG001
num Affected
5
num At Risk
21
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
6
num At Risk
21
num Events
9
group Id
EG001
num Affected
5
num At Risk
21
num Events
6
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
5
num At Risk
21
num Events
5
group Id
EG001
num Affected
5
num At Risk
21
num Events
5
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
7
num At Risk
21
num Events
9
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
4
num At Risk
21
num Events
4
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
3
num At Risk
21
num Events
4
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
2
num At Risk
21
num Events
2
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
6
num At Risk
21
num Events
6
group Id
EG001
num Affected
9
num At Risk
21
num Events
10
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
3
num At Risk
21
num Events
3
term
Non-cardiac chest pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
2
num At Risk
21
num Events
2
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
2
num At Risk
21
num Events
2
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
1
num At Risk
21
num Events
1
group Id
EG001
num Affected
0
num At Risk
21
num Events
0
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Enterocolitis infectious
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (23.1)
stats
group Id
EG000
num Affected
0
num At Risk
21
num Events
0
group Id
EG001
num Affected
1
num At Risk
21
num Events
1
term
Urinary tract infection

time Frame

Treatment-emergent adverse events and all-cause mortality were reported from the first dose of study treatment (Day 1) through 30 days after the end of study treatment (approximately 33 months).

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