NCT01897571 · ADVERSE EVENTS

Adverse events

Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL · Source last updated 2024-03-26

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 are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
Other-event reporting threshold: 5%

The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: Tazemetostat 100 mg Patients received tazemetostat 100 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	1 / 6	6 / 6	2 / 6
Phase 1: Tazemetostat 200 mg Patients received tazemetostat 200 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	1 / 3	3 / 3	2 / 3
Phase 1: Tazemetostat 400 mg Patients received tazemetostat 400 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	2 / 3	3 / 3	3 / 3
Phase 1: Tazemetostat 800 mg Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	2 / 14	12 / 14	6 / 14
Phase 1: Tazemetostat 1600 mg Patients received tazemetostat 1600 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	5 / 12	11 / 12	7 / 12
Phase 1: Food Effect (All Patients) Patients received tazemetostat 200 mg as a single oral dose on Day -8 either after fasting for 8 hours before dosing or immediately after consuming a high-fat breakfast on Day -8. Following a 7-day washout period, patients crossed over to receive the second tazemetostat 200 mg single oral dose on Day -1 in the opposite condition (fed or fasted).	6 / 13	12 / 13	9 / 13
Phase 1: Tazemetostat 800 mg + Midazolam 2 mg Patients received tazemetostat 800 mg orally BID continuously starting on Day 1, with a single oral dose of midazolam 2 mg administered on Day -1 and then on Day 15. Post Day 15, patients continued to receive tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	2 / 13	13 / 13	5 / 13
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2 Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	14 / 48	46 / 48	22 / 48
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2 Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	16 / 54	53 / 54	23 / 54
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.	84 / 163	147 / 163	129 / 163
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.	47 / 71	56 / 71	59 / 71

Group identifiers: EG000: Phase 1: Tazemetostat 100 mg · EG001: Phase 1: Tazemetostat 200 mg · EG002: Phase 1: Tazemetostat 400 mg · EG003: Phase 1: Tazemetostat 800 mg · EG004: Phase 1: Tazemetostat 1600 mg · EG005: Phase 1: Food Effect (All Patients) · EG006: Phase 1: Tazemetostat 800 mg + Midazolam 2 mg · EG007: Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2 · EG008: Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2 · EG009: Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy · EG010: Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy

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
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
1
num At Risk
48
group Id
EG008
num Affected
1
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
2
num At Risk
71
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
0
num At Risk
163
group Id
EG010
num Affected
0
num At Risk
71
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
1
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
0
num At Risk
163
group Id
EG010
num Affected
0
num At Risk
71
term
Empyema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
1
num At Risk
54
group Id
EG009
num Affected
2
num At Risk
163
group Id
EG010
num Affected
1
num At Risk
71
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
0
num At Risk
71
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
0
num At Risk
163
group Id
EG010
num Affected
1
num At Risk
71
term
Tumor pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
2
num At Risk
54
group Id
EG009
num Affected
3
num At Risk
163
group Id
EG010
num Affected
3
num At Risk
71
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
1
num At Risk
54
group Id
EG009
num Affected
8
num At Risk
163
group Id
EG010
num Affected
7
num At Risk
71
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
2
num At Risk
71
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
1
num At Risk
54
group Id
EG009
num Affected
12
num At Risk
163
group Id
EG010
num Affected
7
num At Risk
71
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
1
num At Risk
71
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
0
num At Risk
71
term
Anxiety

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
CTCAE v 4.03
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
6
num At Risk
13
group Id
EG007
num Affected
3
num At Risk
48
group Id
EG008
num Affected
10
num At Risk
54
group Id
EG009
num Affected
25
num At Risk
163
group Id
EG010
num Affected
13
num At Risk
71
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
4
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
4
num At Risk
48
group Id
EG008
num Affected
5
num At Risk
54
group Id
EG009
num Affected
37
num At Risk
163
group Id
EG010
num Affected
13
num At Risk
71
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
4
num At Risk
48
group Id
EG008
num Affected
4
num At Risk
54
group Id
EG009
num Affected
16
num At Risk
163
group Id
EG010
num Affected
7
num At Risk
71
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
6
num At Risk
12
group Id
EG005
num Affected
3
num At Risk
13
group Id
EG006
num Affected
2
num At Risk
13
group Id
EG007
num Affected
10
num At Risk
48
group Id
EG008
num Affected
14
num At Risk
54
group Id
EG009
num Affected
36
num At Risk
163
group Id
EG010
num Affected
9
num At Risk
71
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
4
num At Risk
13
group Id
EG007
num Affected
5
num At Risk
48
group Id
EG008
num Affected
7
num At Risk
54
group Id
EG009
num Affected
23
num At Risk
163
group Id
EG010
num Affected
12
num At Risk
71
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
3
num At Risk
13
group Id
EG006
num Affected
3
num At Risk
13
group Id
EG007
num Affected
5
num At Risk
48
group Id
EG008
num Affected
3
num At Risk
54
group Id
EG009
num Affected
14
num At Risk
163
group Id
EG010
num Affected
4
num At Risk
71
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
11
num At Risk
48
group Id
EG008
num Affected
10
num At Risk
54
group Id
EG009
num Affected
28
num At Risk
163
group Id
EG010
num Affected
11
num At Risk
71
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
8
num At Risk
48
group Id
EG008
num Affected
5
num At Risk
54
group Id
EG009
num Affected
12
num At Risk
163
group Id
EG010
num Affected
12
num At Risk
71
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
5
num At Risk
48
group Id
EG008
num Affected
2
num At Risk
54
group Id
EG009
num Affected
8
num At Risk
163
group Id
EG010
num Affected
2
num At Risk
71
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
4
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
10
num At Risk
14
group Id
EG004
num Affected
4
num At Risk
12
group Id
EG005
num Affected
7
num At Risk
13
group Id
EG006
num Affected
7
num At Risk
13
group Id
EG007
num Affected
7
num At Risk
48
group Id
EG008
num Affected
12
num At Risk
54
group Id
EG009
num Affected
16
num At Risk
163
group Id
EG010
num Affected
15
num At Risk
71
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
5
num At Risk
48
group Id
EG008
num Affected
3
num At Risk
54
group Id
EG009
num Affected
12
num At Risk
163
group Id
EG010
num Affected
8
num At Risk
71
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
3
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
2
num At Risk
48
group Id
EG008
num Affected
8
num At Risk
54
group Id
EG009
num Affected
25
num At Risk
163
group Id
EG010
num Affected
7
num At Risk
71
term
Pyrexia

Complete source fields

description

event Groups

deaths Num Affected
2
deaths Num At Risk
6
description
Patients received tazemetostat 100 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Phase 1: Tazemetostat 100 mg
deaths Num Affected
2
deaths Num At Risk
3
description
Patients received tazemetostat 200 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase 1: Tazemetostat 200 mg
deaths Num Affected
3
deaths Num At Risk
3
description
Patients received tazemetostat 400 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase 1: Tazemetostat 400 mg
deaths Num Affected
6
deaths Num At Risk
14
description
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG003
other Num Affected
12
other Num At Risk
14
serious Num Affected
2
serious Num At Risk
14
title
Phase 1: Tazemetostat 800 mg
deaths Num Affected
7
deaths Num At Risk
12
description
Patients received tazemetostat 1600 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG004
other Num Affected
11
other Num At Risk
12
serious Num Affected
5
serious Num At Risk
12
title
Phase 1: Tazemetostat 1600 mg
deaths Num Affected
9
deaths Num At Risk
13
description
Patients received tazemetostat 200 mg as a single oral dose on Day -8 either after fasting for 8 hours before dosing or immediately after consuming a high-fat breakfast on Day -8. Following a 7-day washout period, patients crossed over to receive the second tazemetostat 200 mg single oral dose on Day -1 in the opposite condition (fed or fasted).
id
EG005
other Num Affected
12
other Num At Risk
13
serious Num Affected
6
serious Num At Risk
13
title
Phase 1: Food Effect (All Patients)
deaths Num Affected
5
deaths Num At Risk
13
description
Patients received tazemetostat 800 mg orally BID continuously starting on Day 1, with a single oral dose of midazolam 2 mg administered on Day -1 and then on Day 15. Post Day 15, patients continued to receive tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG006
other Num Affected
13
other Num At Risk
13
serious Num Affected
2
serious Num At Risk
13
title
Phase 1: Tazemetostat 800 mg + Midazolam 2 mg
deaths Num Affected
22
deaths Num At Risk
48
description
Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG007
other Num Affected
46
other Num At Risk
48
serious Num Affected
14
serious Num At Risk
48
title
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2
deaths Num Affected
23
deaths Num At Risk
54
description
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG008
other Num Affected
53
other Num At Risk
54
serious Num Affected
16
serious Num At Risk
54
title
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
deaths Num Affected
129
deaths Num At Risk
163
description
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
id
EG009
other Num Affected
147
other Num At Risk
163
serious Num Affected
84
serious Num At Risk
163
title
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
deaths Num Affected
59
deaths Num At Risk
71
description
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
id
EG010
other Num Affected
56
other Num At Risk
71
serious Num Affected
47
serious Num At Risk
71
title
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
6
num At Risk
13
group Id
EG007
num Affected
3
num At Risk
48
group Id
EG008
num Affected
10
num At Risk
54
group Id
EG009
num Affected
25
num At Risk
163
group Id
EG010
num Affected
13
num At Risk
71
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
4
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
4
num At Risk
48
group Id
EG008
num Affected
5
num At Risk
54
group Id
EG009
num Affected
37
num At Risk
163
group Id
EG010
num Affected
13
num At Risk
71
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
4
num At Risk
48
group Id
EG008
num Affected
4
num At Risk
54
group Id
EG009
num Affected
16
num At Risk
163
group Id
EG010
num Affected
7
num At Risk
71
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
6
num At Risk
12
group Id
EG005
num Affected
3
num At Risk
13
group Id
EG006
num Affected
2
num At Risk
13
group Id
EG007
num Affected
10
num At Risk
48
group Id
EG008
num Affected
14
num At Risk
54
group Id
EG009
num Affected
36
num At Risk
163
group Id
EG010
num Affected
9
num At Risk
71
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
4
num At Risk
13
group Id
EG007
num Affected
5
num At Risk
48
group Id
EG008
num Affected
7
num At Risk
54
group Id
EG009
num Affected
23
num At Risk
163
group Id
EG010
num Affected
12
num At Risk
71
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
3
num At Risk
13
group Id
EG006
num Affected
3
num At Risk
13
group Id
EG007
num Affected
5
num At Risk
48
group Id
EG008
num Affected
3
num At Risk
54
group Id
EG009
num Affected
14
num At Risk
163
group Id
EG010
num Affected
4
num At Risk
71
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
11
num At Risk
48
group Id
EG008
num Affected
10
num At Risk
54
group Id
EG009
num Affected
28
num At Risk
163
group Id
EG010
num Affected
11
num At Risk
71
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
3
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
8
num At Risk
48
group Id
EG008
num Affected
5
num At Risk
54
group Id
EG009
num Affected
12
num At Risk
163
group Id
EG010
num Affected
12
num At Risk
71
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
5
num At Risk
48
group Id
EG008
num Affected
2
num At Risk
54
group Id
EG009
num Affected
8
num At Risk
163
group Id
EG010
num Affected
2
num At Risk
71
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
4
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
10
num At Risk
14
group Id
EG004
num Affected
4
num At Risk
12
group Id
EG005
num Affected
7
num At Risk
13
group Id
EG006
num Affected
7
num At Risk
13
group Id
EG007
num Affected
7
num At Risk
48
group Id
EG008
num Affected
12
num At Risk
54
group Id
EG009
num Affected
16
num At Risk
163
group Id
EG010
num Affected
15
num At Risk
71
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
13
group Id
EG007
num Affected
5
num At Risk
48
group Id
EG008
num Affected
3
num At Risk
54
group Id
EG009
num Affected
12
num At Risk
163
group Id
EG010
num Affected
8
num At Risk
71
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
3
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
2
num At Risk
48
group Id
EG008
num Affected
8
num At Risk
54
group Id
EG009
num Affected
25
num At Risk
163
group Id
EG010
num Affected
7
num At Risk
71
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
1
num At Risk
48
group Id
EG008
num Affected
1
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
2
num At Risk
71
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
0
num At Risk
163
group Id
EG010
num Affected
0
num At Risk
71
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
1
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
0
num At Risk
163
group Id
EG010
num Affected
0
num At Risk
71
term
Empyema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
1
num At Risk
54
group Id
EG009
num Affected
2
num At Risk
163
group Id
EG010
num Affected
1
num At Risk
71
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
0
num At Risk
71
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
0
num At Risk
163
group Id
EG010
num Affected
1
num At Risk
71
term
Tumor pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
2
num At Risk
54
group Id
EG009
num Affected
3
num At Risk
163
group Id
EG010
num Affected
3
num At Risk
71
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
2
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
1
num At Risk
54
group Id
EG009
num Affected
8
num At Risk
163
group Id
EG010
num Affected
7
num At Risk
71
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
2
num At Risk
71
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
1
num At Risk
54
group Id
EG009
num Affected
12
num At Risk
163
group Id
EG010
num Affected
7
num At Risk
71
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
14
group Id
EG004
num Affected
1
num At Risk
12
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
1
num At Risk
71
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v 4.03
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
14
group Id
EG004
num Affected
0
num At Risk
12
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
13
group Id
EG007
num Affected
0
num At Risk
48
group Id
EG008
num Affected
0
num At Risk
54
group Id
EG009
num Affected
1
num At Risk
163
group Id
EG010
num Affected
0
num At Risk
71
term
Anxiety

time Frame

Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2

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Preserved source evidence · Not medical advice