NCT03364231 · ADVERSE EVENTS

Adverse events

Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma · Source last updated 2023-06-23

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 of study treatment up to end of study (up to approximately 4.2 years)
Other-event reporting threshold: 0%

Safety population included all enrolled participants who received at least one dose of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
MZL: Umbralisib Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.	1 / 8	8 / 8	1 / 8
WM: Umbralisib Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.	0 / 13	13 / 13	0 / 13

Group identifiers: EG000: MZL: Umbralisib · EG001: WM: Umbralisib

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 23.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
13
term
Colitis

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 23.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
4
num At Risk
13
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
3
num At Risk
13
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Mitral valve prolapse
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
13
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Otitis media
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Retinal vein occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Vision blurred

Complete source fields

description

Safety population included all enrolled participants who received at least one dose of study treatment.

event Groups

deaths Num Affected
1
deaths Num At Risk
8
description
Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
MZL: Umbralisib
deaths Num Affected
0
deaths Num At Risk
13
description
Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
id
EG001
other Num Affected
13
other Num At Risk
13
serious Num Affected
0
serious Num At Risk
13
title
WM: Umbralisib

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
8
group Id
EG001
num Affected
4
num At Risk
13
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
3
num At Risk
13
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Mitral valve prolapse
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
13
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Otitis media
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Retinal vein occlusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
13
term
Vision blurred

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
13
term
Colitis

time Frame

From first dose of study treatment up to end of study (up to approximately 4.2 years)

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Preserved source evidence · Not medical advice