NCT05047536 · ADVERSE EVENTS

Adverse events

KZR-261 in Subjects With Advanced Solid Malignancies · Source last updated 2025-12-19

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: Through end of study, up to 2.25 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose 1 Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	0 / 2	2 / 2	0 / 2
Dose 2 Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	0 / 2	2 / 2	0 / 2
Dose 3 Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	0 / 2	1 / 2	0 / 2
Dose 4 Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	3 / 6	6 / 6	1 / 6
Dose 5 Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	3 / 6	6 / 6	1 / 6
Dose 6 Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	3 / 6	6 / 6	0 / 6
Dose 7 Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	0 / 5	5 / 5	0 / 5
Dose 8 Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	8 / 17	17 / 17	0 / 17
Dose 9 Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	4 / 8	7 / 8	0 / 8
Melanoma Expansion Cohort Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.	4 / 7	7 / 7	0 / 7

Group identifiers: EG000: Dose 1 · EG001: Dose 2 · EG002: Dose 3 · EG003: Dose 4 · EG004: Dose 5 · EG005: Dose 6 · EG006: Dose 7 · EG007: Dose 8 · EG008: Dose 9 · EG009: Melanoma Expansion Cohort

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
2
num At Risk
17
num Events
2
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
1
num At Risk
7
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Haematemesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Melaena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
1
num At Risk
7
num Events
1
term
Pancreatitis acute

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 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
2
num At Risk
5
num Events
3
group Id
EG007
num Affected
5
num At Risk
17
num Events
9
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
6
num Events
2
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
5
num Events
6
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
2
num At Risk
5
num Events
3
group Id
EG007
num Affected
6
num At Risk
17
num Events
15
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
2
num At Risk
7
num Events
6
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
1
num At Risk
8
num Events
2
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Cataract nuclear
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Dry eye

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
2
description
Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Dose 1
deaths Num Affected
0
deaths Num At Risk
2
description
Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG001
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Dose 2
deaths Num Affected
0
deaths Num At Risk
2
description
Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG002
other Num Affected
1
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Dose 3
deaths Num Affected
1
deaths Num At Risk
6
description
Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Dose 4
deaths Num Affected
1
deaths Num At Risk
6
description
Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Dose 5
deaths Num Affected
0
deaths Num At Risk
6
description
Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Dose 6
deaths Num Affected
0
deaths Num At Risk
5
description
Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG006
other Num Affected
5
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Dose 7
deaths Num Affected
0
deaths Num At Risk
17
description
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG007
other Num Affected
17
other Num At Risk
17
serious Num Affected
8
serious Num At Risk
17
title
Dose 8
deaths Num Affected
0
deaths Num At Risk
8
description
Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG008
other Num Affected
7
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
Dose 9
deaths Num Affected
0
deaths Num At Risk
7
description
Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
id
EG009
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
Melanoma Expansion Cohort

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
2
num At Risk
5
num Events
3
group Id
EG007
num Affected
5
num At Risk
17
num Events
9
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
6
num Events
2
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
1
num At Risk
5
num Events
6
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
2
num At Risk
5
num Events
3
group Id
EG007
num Affected
6
num At Risk
17
num Events
15
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
2
num At Risk
7
num Events
6
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
1
num At Risk
8
num Events
2
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Cataract nuclear
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Dry eye

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
2
num At Risk
17
num Events
2
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
1
num At Risk
7
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
1
num At Risk
8
num Events
1
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Haematemesis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
17
num Events
1
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Melaena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
6
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
0
num At Risk
7
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
2
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
6
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
17
num Events
0
group Id
EG008
num Affected
0
num At Risk
8
num Events
0
group Id
EG009
num Affected
1
num At Risk
7
num Events
1
term
Pancreatitis acute

time Frame

Through end of study, up to 2.25 years

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

Preserved source evidence · Not medical advice